Download Register

ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER

S/No Product Name Generic Name Category of Dosage Form Marketing Marketing Authorisation Holder Distribution Authorisation Number Miconazole Nitrate Ceam - 1 A Miconazole Nitrate 20mg POM Cream Topical 046/002 1 A Pharma Gmbh, Germany 1 Pharma cream Cetirizine 10 - 1 A Pharma Cetirizine Dihydrochloride POM Tablet Uncoated 046/003 1 A Pharma Gmbh, Germany 2 tablets 10mg 3 Ateblock - 25 Tablets Atenolol 25mg POM Tablet Uncoated 116/001 AB Lifesciences, India 4 Ateblock - 50 Tablets Atenolol 50mg POM Tablet Uncoated 116/002 AB Lifesciences, India 5 Ateblock - 100 Tablets Atenolol 100mg POM Tablet Uncoated 116/003 AB Lifesciences, India 6 Nosieze Tablets Carbamazepine 400mg POM Tablet Uncoated 116/004 AB Lifesciences, India Amoxicillin Trihydrate POM Capsule Oral 116/006 AB Lifesciences, India Neumox Capsules 7 500mg Sodium Lactate + POM Solution for 316/001 Abacus Parenteral Drugs Ltd, India Sodium Chloride + infusion RL-500 Compound Sodium Potassium Chloride + Lactate Infusion Calcium Chloride 8 Dihydrate NS - 500 Sodium Chloride BP Sodium Chloride POM Solution for 316/002 Abacus Parenteral Drugs Ltd, India 9 Infusion 0.9%w/v infusion Dextrose 5.0g POM Solution for 316/003 Abacus Parenteral Drugs Ltd, India DS-500 Glucose Infusion 10 infusion Betamethasone Soduim POM Solution for Topical 316/004 Abacus Parenteral Drugs Ltd, India X-Beta Eye/Ear Drops 11 Phosphate 0.1% w/v Use Betamethasone Soduim POM Solution for Topical 316/005 Abacus Parenteral Drugs Ltd, India Phosphate 0.1% w/v + Use X- Beta - N Eye/Ear Drops Neomycin sulphate 0.5% 12 w/v Neomycin Sulphate POM Solution for Topical 316/006 Abacus Parenteral Drugs Ltd, India 0.35% w/v + Use X-Sone -N Eye/Ear Drops Dexamethasone 13 Phosphate 0.1% w/v Sodium Chloride 0.9% P Solution for Topical 316/007 Abacus Parenteral Drugs Ltd, India Abnal Nasal Drops 14 w/v Use Mannitol 20 %w/v POM Solution for 316/008 Abacus Parenteral Drugs Ltd, India Abtol 20% Intravenous Infusion 15 infusion Lopinavir 80mg + POM Solution for Oral 128/002 Abbott Laboratories S.A (Pty) Ltd, South Kaletra Solution 16 Ritonavir 20mg, per 5ml Use Africa

Page 1 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Klacid P 125 Granules for Clarithromycin 125mg POM Granules for 128/004 Abbott Laboratories S.A (Pty) Ltd, South 17 Suspension Suspension Africa Klacid P 250 Granules for Clarithromycin 250mg POM Granules for 128/005 Abbott Laboratories S.A (Pty) Ltd, South 18 Suspension Suspension Africa Isoflurane 99.9% w/w POM Solution for 128/015 Abbott Laboratories S.A (Pty) Ltd, South Forane Liquid 19 Inhalation Africa Lopinavir 200mg + POM Tablet Film Coated 128/026 Abbott Laboratories S.A (Pty) Ltd, South Aluvia 250/50mg Tablets 20 Ritonavir 50mg Africa Lopinavir 100mg + POM Tablet Film Coated 128/027 Abbott Laboratories S.A (Pty) Ltd, South Aluvia 100/25mg Tablets 21 Ritonavir 25mg Africa Sevoflurane 100% v/v POM Solution for 128/029 Abbott Laboratories S.A (Pty) Ltd, South Ultane Liquid 22 Inhalation Africa Ritonavir USP 100mg POM Tablet, Film Coated 128/030 Abbott Laboratories S.A (Pty) Ltd, South Norvir 100 Tablets 23 Africa Racecaggherdotril 100mg POM Capsule, Oral 128/031 Abbott Laboratories S.A (Pty) Ltd, South Hidrasec Capsules 24 Africa Racecaggherdotril 30mg POM Powder for 128/032 Abbott Laboratories S.A (Pty) Ltd, South Hidrasec Children Sachets 25 Suspension, Oral Africa Racecaggherdotril 10mg POM Powder for 128/033 Abbott Laboratories S.A (Pty) Ltd, South Hidrasec Infant Sachets 26 Suspension, Oral Africa Survanta Intratracheal Total Phospholipids POM Suspension, 128/034 Abbott Laboratories S.A (Pty) Ltd, South 27 Suspension, 4ml Vial 25mg, per ml Intratracheal Africa Calmettes Nite 45mg tablets Valerian Dry Root extract P Tablet Film coated 128/035L Abbott Laboratories S.A (Pty) Ltd, South 28 45mg Africa Calmettes Nite 125mg tablets Valerian Dry Root extract P Tablet Film coated 128/036L Abbott Laboratories S.A (Pty) Ltd, South 29 45mg Africa Mifepristone 200mg + POM Tablet, Uncoated 296/001 Acme Formulation Pvt Ltd, India Mariprist Combikit Tablets 30 Misoprostal 200mcg 31 Misoclear Tablets Misoprostal 200mcg POM Tablet Uncoated 296/002 Acme Formulation Pvt Ltd, India Mannitol 20% w/v POM Solution, Infusion 097/004 Adcock Ingram Pharmaceuticals Ltd, South Sabax Osmitrol 20% Injection 32 Africa Sabax Sodium Chloride 0.9% Sodium Chloride 0.9% POM Solution, Infusion 097/005 Adcock Ingram Pharmaceuticals Ltd, South 33 Injection w/v Africa Dextrose 5 %w/v + POM Solution, Infusion 097/006 Adcock Ingram Pharmaceuticals Ltd, South Sabax Glucose 5% + Sodium Soduim Chloride 0.9 Africa Chloride 0.9% Injection 34 %w/v

Page 2 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Sodium chloride + POM Solution, Infusion 097/007 Adcock Ingram Pharmaceuticals Ltd, South Sodium lactate + Africa Sabax Ringer Lactate Injection Potassium chloride + 35 Calcium chloride Peritoneal dialysis POM Solution, Injection 097/008 Adcock Ingram Pharmaceuticals Ltd, South Sabax Dianeal Injection, 1.5% 36 solution 1.5% Africa Peritoneal dialysis POM Solution, Injection 097/009 Adcock Ingram Pharmaceuticals Ltd, South Sabax Dianeal Injection, 2.5% 37 solution 2.5% Africa Peritoneal dialysis POM Solution, Injection 097/010 Adcock Ingram Pharmaceuticals Ltd, South Sabax Dianeal Injection, 4.25% 38 solution 4.25% Africa Paracetamol 250mg + P Capsule Oral 097/011 Adcock Ingram Pharmaceuticals Ltd, South Myprodol Capsules Ibuprofen 200mg + Africa 39 Codeine 10mg Paracetamol 250mg + P Suspension for 097/012 Adcock Ingram Pharmaceuticals Ltd, South Lotem Suspension 40 Ibuprofen 200mg Oral Use Africa Caffeine 30 mg + P Tablet oral 111/005 Adcock Ingram Pharmaceuticals Ltd, South Codeine 10 mg + Africa Syndol Tablets Doxylamine 5 mg + 41 Paracetamol 450 mg Paracetamol 450 mg + P Tablet oral 111/008 Adcock Ingram Pharmaceuticals Ltd, South Codeine phosphate 10 Africa mg + Doxylamine Betapyn Tablets succinate 5 mg + Caffeine alkaloid 50 42 mg Cetylpyridinium chloride GS Lozenges 111/009 Adcock Ingram Pharmaceuticals Ltd, South Medikeel A Throat Lozenges 1.5 mg + benzocaine 12 Africa 43 mg Benzocaine 10 mg + GS Lozenges 111/014 Adcock Ingram Pharmaceuticals Ltd, South Cepacol Throat Regular Cetylpyridinium chloride Africa Lozenges 44 1.47 mg Theophylline 16.667 mg POM Syrup 111/022 Adcock Ingram Pharmaceuticals Ltd, South + Hydroxyethyl Africa Theophylline 1.667 mg + Diphenhydramine HCl Alcophyllex Mixture 6.667 mg + Ammonium Chloride 120 mg + Sodium Citrate 50 mg/5 45 ml

Page 3 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Cetylpyridinium Chloride GS Solution for Topical 111/023 Adcock Ingram Pharmaceuticals Ltd, South Cepacol Antibacterial 50 mg + Alcohol 15.8 % Use Africa Mouthwash 46 v/v Cetylpyridinium Chloride GS Lozenges 111/024 Adcock Ingram Pharmaceuticals Ltd, South Cepacol Throat Menthol 1.47 mg + Benzyl Alcohol Africa Lozenges 47 6.5 mg Terbutaline 1.25mg + P Syrup 111/025 Adcock Ingram Pharmaceuticals Ltd, South Ammonium Chloride Africa Bronchoped Syrup 60mg + Sodium Citrate 48 25mg Sodium bicarbonate P Granules for 111/026 Adcock Ingram Pharmaceuticals Ltd, South 1.716mg + Tartaric acid Suspension Africa Citro Soda Orange Granules 856mg + Citric acid 702mg + Sodium citrate 49 613mg Sodium bicarbonate P Granules for 111/027 Adcock Ingram Pharmaceuticals Ltd, South 1.716mg + Tartaric acid Suspension Africa Citro Soda Granules 856mg + Citric acid 702mg + Sodium citrate 50 613mg Sennosides dry extract P Tablet Uncoated 111/028 Adcock Ingram Pharmaceuticals Ltd, South Adco-Senna Tablets 60% eq. to 13.50mg Africa 51 Senoside A & B Lignocaine Hydrochloride POM Solution for 111/029 Adcock Ingram Pharmaceuticals Ltd, South 20mg + Adrenaline Injection Africa Locaine A Injection Tartrate 12ug/ml 52 Efavirenz 600mg POM Tablet Film Coated 111/030 Adcock Ingram Pharmaceuticals Ltd, South Adco - Efavirenz 600 Tablets 53 Africa Efavirenz 200mg POM capsule Oral 111/031 Adcock Ingram Pharmaceuticals Ltd, South Adco Efavirenz 200 Capsules 54 Africa Medi - keel A Blackcurrant Benzocaine 12.0mg + P Lozenges 111/032 Adcock Ingram Pharmaceuticals Ltd, South 55 Throat Lozenges Cetylpyridinium 1.5mg Africa Medi - Keel A Honey and Lemon Benzocaine 12.0mg + P Lozenges 111/033 Adcock Ingram Pharmaceuticals Ltd, South 56 Throat Lozenges Cetylpyridinium 1.5mg Africa Theophylline 100mg + P Syrup 111/034 Adcock Ingram Pharmaceuticals Ltd, South Etofyline 10mg + Africa Actophlem Cough Syrup Diphenylpyramine 8mg + 57 Ammonium 720mg

Page 4 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Prednisolone 15mg/5ml POM Syrup 111/035 Adcock Ingram Pharmaceuticals Ltd, South Prelone Syrup 58 Africa Dextromethophan P Syrup 111/036 Adcock Ingram Pharmaceuticals Ltd, South Dilinct Dry Cough Syrup Hydrobromide Ph. Eur Africa 59 15mg/5ml Tramadol Hydrochloride POM Capsule Oral 060/001 Adlife Healthare Pvt Ltd, India Dolo Doc Capsules 60 BP 50mg Amoxycillin Trihdyrate POM Suspension for 060/002 Adlife Healthare Pvt Ltd, India Amoxycillin Oral Suspension 61 125mg/5ml Oral Use SNP IMMUNOboost Tablets Sida cordiflia (Bala) P Capsule oral 449/001L Adventura Investments Limited 150mg + Tinospora 62 cordiflia (Giloya) SNP JOINTcare Tablets Shallaki (Boswelia P Tablet Uncoated 449/002L Adventura Investments Limited serrata) 300mg + Rasna 63 (Pluchea lanceolat Snp Allergy Care Tablets Inula racemose P Tablet Uncoated 449/003L Adventura Investments Limited (Pushkarmool) 75mg + 64 Pistacia integerrima (Ka SNP Brain Tonic Tablets Ocimum sanctum (Tulsi) P Tablet Uncoated 449/004L Adventura Investments Limited 200mg + Centella 65 asiatica (Mandukparn 66 Oxacid 200mg Capsules Ofloxacin 200mg POM Capsule oral 137/002 Aegis Limited, Cyprus Cefixime Trihydrate POM Suspension for 137/003 Aegis Limited, Cyprus Cifex Suspension 67 100mg/5ml Oral Use 68 Cifex 200 Tablets Cefixime 200mg POM Tablet Uncoated 137/004 Aegis Limited, Cyprus Cefixime Trihydrate POM Tablet Uncoated 137/005 Aegis Limited, Cyprus Cefixime 400mg Tablets 69 400mg 70 Lasoprol 30 Capsules Lansoprazole 30 mg POM Capsule oral 137/001 Aegis Limited,Cyprus Alpha Lipoic Acid P Capsule Hard 368/001L African Health Solutions Ltd 18.75mg + Beta Gelatin Selenaid Forte Nutritional Carotene 0.31mg + Supplement Capsules Betaine (TMG) 12.5mg + Bioperine 0.3mg + Biotin 71 3mcg 72 Chlorosim - 250 Capsules Chlorampehicol 250mg POM Capsule oral 090/011 Africure Pharmaceuticals Ltd 73 Doxyrone - 100 Capsules Doxycycline 100mg POM Capsule oral 090/012 Africure Pharmaceuticals Ltd 74 Metrosim 200mg Tablets Metronidazole 200mg POM Tablet 286/002 Africure Pharmaceuticals Ltd 75 Simfen 200mg Tablets Ibuprofen 200mg P Tablet 286/003 Africure Pharmaceuticals Ltd

Page 5 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Magnesium Trisilicate GS Tablet 286/007 Africure Pharmaceuticals Ltd Compound Magnesium 250mg + Aluminium Trisilicate Tablets BP 76 Hydroxide 120mg 77 Erythone 250mg Tablets Erythromycin 250mg POM Tablet 286/011 Africure Pharmaceuticals Ltd 78 Cipone 500mg Tablets Ciprofloxacin 500mg POM Tablet 286/012 Africure Pharmaceuticals Ltd 79 Simdol 500mg Tablets Paracetamol 500 mg P Tablet 286/014 Africure Pharmaceuticals Ltd Ceftriaxone Sodium USP POM Powder for 406/002 Agila Specialties Pvt Limited. Celltriaxon Injection 80 1g Injection Dichlorobenzyl alcohol + GS Lozenges 176/001 Agio Pharmaceutical Limited, India Agisept Antiseptic Lozenges 81 Amyl metacresol Dichlorobenzyl alcohol + GS Lozenges 176/002 Agio Pharmaceutical Limited, India Agisept Antiseptic Lozenges 82 Amyl metacresol Agisept Antiseptic (Classical) Dichlorobenzyl alcohol + GS Lozenges 176/003 Agio Pharmaceutical Limited, India 83 Lozenges Amyl metacresol Diclofenac Sodium P Tablet Uncoated 176/004 Agio Pharmaceutical Limited, India Diclogen Tablets 84 100mg 85 Salbutamol Lifeforce Tablets Salbutamol 2mg POM Tablet Uncoated 176/005 Agio Pharmaceutical Limited, India 86 Griseofulvin 500 Tablets Griseofulvin 500mg POM Tablet Uncoated 176/006 Agio Pharmaceutical Limited, India Sulfamethoxazole BP POM Tablet Uncoated 176/007 Agio Pharmaceutical Limited, India Sepralin Tablets 400 mg + Trimethoprim 87 BP 80mg 88 Nalidixic Acid Lifeforce tablets Nalidixic Acid 500mg POM Tablet Uncoated 176/008 Agio Pharmaceutical Limited, India 89 Cloxacillin Lifeforce Capsules Cloxacllin 250mg POM Capsule Oral 176/009 Agio Pharmaceutical Limited, India Tetracycline 250mg POM Capsule Oral 176/010 Agio Pharmaceutical Limited, India Tetracycline Lifeforce Capsules 90 91 Para Force Tablets Paracetamol BP 500mg GS Tablet Uncoated 176/011 Agio Pharmaceutical Limited, India 92 Ferrous Sulphate Tablets Ferrous Sulphate 200mg P Tablet Film coated 176/012 Agio Pharmaceutical Limited, India Chloramphenicol Lifeforce Chloramphenicol BP POM Capsule oral 176/013 Agio Pharmaceutical Limited, India 93 Capsules 250mg Paracetamol 125mg/5ml GS Suspension for 176/015 Agio Pharmaceutical Limited, India Paraforce Suspension 94 Oral Use Paracetamol 125mg/5ml GS Suspension for 176/015 Agio Pharmaceutical Limited, India Paracetamol Agio Suspension 95 Oral Use Ferrous Sulphate and Folic Acid Ferrous Sulphate 200mg P Tablet Film coated 176/016 Agio Pharmaceutical Limited, India 96 tablets + Folic Acid 0.25mg 97 Moxforce Capsules Amoxicillin 250mg POM Capsule oral 176/017 Agio Pharmaceutical Limited, India 98 Doxycycline Life Capsules Doxycycline 100mg POM Capsule oral 176/018 Agio Pharmaceutical Limited, India 99 Doxycycline Life Capsules Doxycline 100mg BP POM Capsule oral 176/018 Agio Pharmaceutical Limited, India 100 Metroforce Tablets Metronidazole 200mg POM Tablet Uncoated 176/019 Agio Pharmaceutical Limited, India

Page 6 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 101 Metronidazole Agio Tablets Metronidazole 200mg POM Tablets 176/019 Agio Pharmaceutical Limited, India Aluminium Hydroxide P Tablet Uncoated 176/020 Agio Pharmaceutical Limited, India Compound Magnesium 120mg + Magnesium Trisilicate Tablets 102 Trisilscate 250mg 103 Ibufen Tablets Ibuprofen 200mg P Tablet Uncoated 176/021 Agio Pharmaceutical Limited, India 104 Nuamp Capsules Ampicillin 250mg POM Capsule oral 176/022 Agio Pharmaceutical Limited, India Albendazole Lifeforce Albendazole BP P Suspension for 176/023 Agio Pharmaceutical Limited, India 105 Suspension 400mg/10ml Oral Use Gentamicin 40mg/ml POM Solution for 176/024 Agio Pharmaceutical Limited, India Gentamicin Lifeforce Injection 106 Injection Metoclopramide Lifeforce Metoclopramide BP POM Solution for 176/025 Agio Pharmaceutical Limited, India 107 Injection 10mg/2ml Injection Diclofenac Sodium BP POM Solution for 176/026 Agio Pharmaceutical Limited, India Mobiram Injection 108 75mg/3ml Injection Dicyclomine POM Solution for 176/027 Agio Pharmaceutical Limited, India Dicyclone Lifeforce Injection 109 Hydrochloride 20mg/2ml Injection 110 Clovirax Cream Acyclovir 5%w/v POM Cream Topical 176/028 Agio Pharmaceutical Limited, India 111 Micoson 2% Cream Miconazole 2% w/v POM Cream Topical 176/029 Agio Pharmaceutical Limited, India Miconazole Nitrate 2% POM Topical cream 176/029 Agio Pharmaceutical Limited, India Micoson 2% Cream 112 w/v Erythromycin Stearate POM Tablet Uncoated 176/030 Agio Pharmaceutical Limited, India Erycin Tablets 113 BP 250mg 114 Methyldopa Lifeforce Tablets Methyldopa BP 250mg POM Tablet Film coated 176/031 Agio Pharmaceutical Limited, India Salbutamol Lifeforce 4mg Salbutamol 4mg POM Tablet Uncoated 176/032 Agio Pharmaceutical Limited, India 115 Tablets 116 Rulicin 150mg Tablets Roxithromycin 150mg POM Tablet Uncoated 176/033 Agio Pharmaceutical Limited, India B-Complex 10ml POM Solution for 176/034 Agio Pharmaceutical Limited, India B-Complex Agio Injection 117 Injection Dexamethasone BP POM Solution for 176/035 Agio Pharmaceutical Limited, India Dexamethasone - Agio Injection 118 4mg/ml Injection 119 Agovir Tablets Aciclovir 200mg POM Tablet Uncoated 202/001 Agog Pharma Ltd, India Aluminium Hydroxide GS Tablet Uncoated 202/002 Agog Pharma Ltd, India Compound Magnesium Tablets 120mg + Magnesium 120 Trisiliscate 250mg 121 Indo-25 Capsules Indomethacin BP 25mg P Capsule oral 202/003 Agog Pharma Ltd, India 122 Cipro 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 202/004 Agog Pharma Ltd, India Sulfamethoxazole 400mg POM Tablet Uncoated 202/005 Agog Pharma Ltd, India Trimago 480 Tablets + Trimethoprim 80mg 123

Page 7 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 124 Agofen 200mg Tablets Ibuprofen 200mg P Tablet Film coated 202/006 Agog Pharma Ltd, India 125 Agoxic Tablets Nalidixic Acid 500mg POM Tablet Uncoated 202/007 Agog Pharma Ltd, India 126 Metronidazole Tablets Metronidazole 200mg POM Tablet Film coated 202/008 Agog Pharma Ltd, India Diclofenac Sodium P Tablet Film coated 202/009 Agog Pharma Ltd, India Diclofenac Sodium Tablets 127 100mg Sulfamethoxazole 200mg POM Tablet Film coated 202/010 Agog Pharma Ltd, India Trimago 240 Tablets +Trimethoprim 40mg 128 129 Ibuprofen Tablets Ibuprofen 200mg P Tablet Uncoated 202/011 Agog Pharma Ltd, India 130 Heath E.Tonic Syrup Haematinic preparation P Syrup 202/012 Agog Pharma Ltd, India Metronidazole POM Suspension for 202/013 Agog Pharma Ltd, India Agometro Suspension 131 125mg/5ml Oral Use 132 B-Cox Tablets B Complex P Tablet Film coated 202/015 Agog Pharma Ltd, India 133 Agomol Tablets Paracetamol 500mg GS Tablet Uncoated 202/016 Agog Pharma Ltd, India 134 Fluconazole Capsules Fluconazole 200mg POM Capsule oral 202/017 Agog Pharma Ltd, India Ascorbic Acid BP 100mg GS Tablet Uncoated 202/018 Agog Pharma Ltd, India Ago-C 100mg Tablets 135 Ascorbic Acid BP 500mg GS Tablet Chewable 202/019 Agog Pharma Ltd, India Ago-C 500mg Tablets 136 137 B-twin Tablets B Complex P Tablet Film coated 202/020 Agog Pharma Ltd, India Metronidazole 5mg/ml POM Solution for 203/001 Ahlcon Parenterals (India) Ltd, India Metronidazole Injection 138 infusion Fluconazole 2mg/ml POM Solution for 203/002 Ahlcon Parenterals (India) Ltd, India Fluconazole Injection 139 infusion Ciprofloxacin 2mg/ml POM Solution for 203/003 Ahlcon Parenterals (India) Ltd, India Ciprofloxacin Injection 140 infusion Potassuim chloride + POM Solution for 203/004 Ahlcon Parenterals (India) Ltd, India Darrow's Solution Sodium chloride + infusion 141 Sodium lactate Potassuim Chloride + POM Solution for 203/005 Ahlcon Parenterals (India) Ltd, India Compound Sodium Lactate Sodium Chloride + infusion Solution 142 Sodium Lactate 143 Quinine Sulphate Tablets Quinine Sulphate 300mg POM Tablet Uncoated 115/001 Ajanta Pharma Limited, India 144 Fingurin Capsules Herbal extracts 407mg P Capsule Oral 115/001H Ajanta Pharma Limited, India 145 Indoflam Capsules Indomethacin BP 25mg P Capsule oral 115/002 Ajanta Pharma Limited, India 146 Apdyl-H Syrup Herbal extracts 335mg GS Syrup 115/002H Ajanta Pharma Limited, India 147 Apkef Capsules Cephalexin 250mg POM Capsule oral 115/003 Ajanta Pharma Limited, India 148 Tyflox Capsules Ciprofloxacin 250mg POM Capsule oral 115/004 Ajanta Pharma Limited, India 149 Thirty Plus Capsules Ginseng extract 1000mg P Capsule oral 115/004H Ajanta Pharma Limited, India

Page 8 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 150 Apthromycin Tablets Erythromycin 250mg POM Tablet Uncoated 115/005 Ajanta Pharma Limited, India Herbal extracts 45mg GS Solution for Oral 115/005H Ajanta Pharma Limited, India Pinkoo Gripe Water 151 Use 152 Optifenac Tablets Diclofenac 25mg P Tablet Uncoated 115/006 Ajanta Pharma Limited, India 153 Rheumanib Ointment Herbal extracts 14% w/w GS Ointment topical 115/006H Ajanta Pharma Limited, India 154 Optifenac Tablets Diclofenac 50mg P Tablet Uncoated 115/007 Ajanta Pharma Limited, India 155 Apcillin 250 Capsules Ampicillin 250mg POM Capsule oral 115/008 Ajanta Pharma Limited, India 156 Apcillin 500 Capsules Ampicillin 500mg POM Capsule oral 115/009 Ajanta Pharma Limited, India 157 Novaten 50 Tablets Atenonol 50mg POM Tablet Uncoated 115/010 Ajanta Pharma Limited, India 158 Mobaid Tablets Herbal extracts 950mg P Tablet Uncoated 115/010H Ajanta Pharma Limited, India 159 Novaten 100 Tablets Atenolol 100mg POM Tablet Uncoated 115/011 Ajanta Pharma Limited, India 160 Cloxil 250 Capsules Cloxacillin 250mg POM Capsule oral 115/012 Ajanta Pharma Limited, India Mebendazole USP P Tablet Uncoated 115/013 Ajanta Pharma Limited, India Anthalben Tablets 161 100mg 162 Apmox 250 Capsules Amoxicillin 250mg POM Capsule oral 115/014 Ajanta Pharma Limited, India Cloxacillin Sodium BP POM Capsule oral 115/015 Ajanta Pharma Limited, India Cloxa-Plus Capsules 250mg + Ampicillin 163 Trihydrate BP 250mg Sulfamethoxazole 400mg POM Tablet Uncoated 115/017 Ajanta Pharma Limited, India Supreme S.S. Tablet + Trimethoprim 80mg 164 165 Apcalis 10 Tablets Tadalafil 10mg POM Tablet Film coated 115/018 Ajanta Pharma Limited, India 166 Apcalis Plus 20 Tablets Tadalafil 20mg POM Tablet Film coated 115/019 Ajanta Pharma Limited, India Artovastatin Calcium POM Tablet Film coated 115/020 Ajanta Pharma Limited, India Atorfit-10 Tablets 167 10mg Artovastatin Calcium POM Tablet Film coated 115/021 Ajanta Pharma Limited, India Atorfit-20 Tablets 168 20mg Alpha-ß Artemether POM Solution for 115/030 Ajanta Pharma Limited, India Ather Injection 169 75mg/2ml Injection 170 Kamagra Oral Gel Sildenafil Citrate 50mg POM Gel Oral 115/031 Ajanta Pharma Limited, India Isoniazid BP 75mg + POM Tablet Film coated 115/035 Ajanta Pharma Limited, India Anacox Plus LD Tablets 171 Rifampicin BP 150mg 172 Kamagra 100 Tablets Sildenafil Citrate 100mg POM Tablet Uncoated 115/036 Ajanta Pharma Limited, India 173 Kamagra 50 Tablets Sildenafil Citrate 50mg POM Tablet Uncoated 115/037 Ajanta Pharma Limited, India Artemether 20 mg + POM Tablet Uncoated 115/038 Ajanta Pharma Limited, India Artefan 20/120mg Tablets 174 Lumefantrine 120mg Kamagra Oral Jelly 50mg POM 115/039 Sildenafil Citrate 50mg Gel Oral Ajanta Pharma Limited, India 175 Orange 176 Tibinil-P Tablets Pyrazinamide 500mg POM Tablet Uncoated 115/040 Ajanta Pharma Limited, India

Page 9 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 177 Apoxin Tablets Amoxicillin 250mg POM Tablet Uncoated 115/041 Ajanta Pharma Limited, India 178 Tibinil-E 200 Tablets Ethambutol 200mg POM Tablet Uncoated 115/042 Ajanta Pharma Limited, India 179 Tibnil E-400 Tablets Ethambutol 400mg POM Tablet Uncoated 115/043 Ajanta Pharma Limited, India Sulfadoxine 500mg + POM Tablet Uncoated 115/044 Ajanta Pharma Limited, India Combisunate Forte Kit Tablets Pyrimethamine 25mg + 180 Artesunate 100mg Sulphadoxine 500mg + POM Tablet Uncoated 115/045 Ajanta Pharma Limited, India Combisunate Tablets Pyrimethamine 25mg + 181 Artesunate 100mg Artemether 40 mg+ POM Tablet Uncoated 115/046 Ajanta Pharma Limited, India Artefan 40/240mg Tablets 182 Lumefantrine 240mg Artefan Dispersible 20/120 Artemether 20mg + POM Tablet Dispersible 115/047 Ajanta Pharma Limited, India 183 Tablets Lumefantrine 120mg Moxifloxacin HCl 0.5% POM Eye Drops 115/048 Ajanta Pharma Limited, India Adrops Eye Drops 184 w/v 185 Lacoma Eye Drops Lantanoprost 50mcg POM Eye Drops 115/048 Ajanta Pharma Limited, India Lantanoprost 50mcg + POM Eye Drops 115/049 Ajanta Pharma Limited, India Lacoma - T Eye Drops 186 Timolol 6.834mg Artesunate 100mg + POM Tablet Uncoated 115/050 Ajanta Pharma Limited, India Apmod 100/270 Tablets Amodiaquine 187 Hydrochloride 270mg Artesunate 50mg + POM Tablet Uncoated 115/051 Ajanta Pharma Limited, India Apmod 50/135 Tablets 188 Amodiaquine 135mg Artesunate 25mg + POM Tablet Uncoated 115/052 Ajanta Pharma Limited, India Apmod 25/67.5 Tablets 189 Amodiaquine 67.5mg Artemether 80 mg + POM Tablet Uncoated 115/053 Ajanta Pharma Limited, India Artefan 80/480 Tablets 190 Lumefantrine 480mg Artemether 180mg + POM Suspension for 115/054 Ajanta Pharma Limited, India Artefan Suspension 191 Lumefantrine 1080mg Oral Use 192 Levotop 500 Tablets Levofloxacin 500mg POM Tablet Uncoated 115/055 Ajanta Pharma Limited, India Folic acid 100mg + Iron P Capsule oral 115/056 Ajanta Pharma Limited, India 1.5mg + Vit B12 0.015mg Nurifer Capsules + Vit C 75mg + Zinc 193 61.8mg 194 Zaha-250 Tablets Azithromycin 250mg POM Tablet Uncoated 115/057 Ajanta Pharma Limited, India 195 Zaha-500 Tablets Azithromycin 500mg POM Tablet Uncoated 115/058 Ajanta Pharma Limited, India 196 Zolanas-15 Capsules Lansoprazole 15mg POM Capsule oral 115/059 Ajanta Pharma Limited, India 197 Zolanas-30 Capsules Lansoprazole 30mg POM Capsule oral 115/060 Ajanta Pharma Limited, India

Page 10 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Ciprofloxacin 500mg + POM Tablet Uncoated 115/061 Ajanta Pharma Limited, India Ciprozole Forte Tablets 198 Tinidazole 600mg Paracetamol 120mg + P Syrup 115/062 Ajanta Pharma Limited, India ChlorphenIramine Apflu Syrup 0.525mg + Vitamin C 199 50mg Paracetamol 350mg + POM Tablet Uncoated 115/063 Ajanta Pharma Limited, India Apflu Tablet Chlorpheniramine 2mg + 200 Vitamin C 100mg 201 Aprazole Tablets Omeprazole 20mg POM Tablet Uncoated 115/064 Ajanta Pharma Limited, India Atorvastatin 10mg + POM Tablet Uncoated 115/065 Ajanta Pharma Limited, India Atorfit-EZ Tablets 202 Ezetimibe 10mg 203 Fedate Syrup B Complex + Minerals P Syrup 115/066 Ajanta Pharma Limited, India Fluconazole 150mg + POM Tablet Uncoated 115/067 Ajanta Pharma Limited, India Dazel-Kit Tablets Azithromycin 1g + 204 Secnidazole 1g Dihydoartimimine 40mg + POM Tablet Uncoated 115/068 Ajanta Pharma Limited, India Ridmal 40/320 Tablets 205 Piperaquine 320mg Kamagra -100 Efferscent Sildenafil Citrate 100mg POM Tablet Effervescent 115/069 Ajanta Pharma Limited, India 206 Tablets - Orange Flavour 207 Kamagra Oral Jelly Sildenafil Citrate 100mg POM Gel Oral 115/070 Ajanta Pharma Limited, India Kamagra Oral Jelly - Pineapple Sildenafil Citrate 100mg POM Gel Oral 115/071 Ajanta Pharma Limited, India 208 Flavour Kamagra Oral Jelly - Strawberry Sildenafil Citrate 100mg POM Gel Oral 115/072 Ajanta Pharma Limited, India 209 Flavour 210 Instaclop 75 Tablets Clopidogrel USP 75mg POM Tablet Film coated 115/073 Ajanta Pharma Limited, India 211 Talimus 0.03% Ointment Tacrolimus 0.03% w/w POM Ointment topical 115/074 Ajanta Pharma Limited, India 212 Talimus 0.1% Ointment Tacrolimus 0.1% w/w POM Ointment topical 115/075 Ajanta Pharma Limited, India Candesartan cilexetil POM Tablet Uncoated 115/076 Ajanta Pharma Limited, India Aderan 8 Tablets 213 8mg Candesartan cilexetil POM Tablet Uncoated 115/077 Ajanta Pharma Limited, India Aderan 16 Tablets 214 16mg Candesartan cilexetil POM Tablet Uncoated 115/078 Ajanta Pharma Limited, India Aderan 32 Tablets 215 32mg Aceclofenac 100mg + P Tablet oral 115/079 Ajanta Pharma Limited, India Acinac Plus Tablets 216 Paracetamol 350mg 217 Apcalis SX 20 Orange Jelly Tadalafil 20mg POM Gel Oral 115/080 Ajanta Pharma Limited, India 218 Apcalis SX 20 Mint Jelly Tadalafil 20mg POM Gel Oral 115/081 Ajanta Pharma Limited, India

Page 11 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Azithromycin Dihydrate POM Suspension for 115/089 Ajanta Pharma Limited, India Zaha Suspension 219 USP 200mg Oral Use Aspirin BP 75mg + POM Capsule oral 115/090 Ajanta Pharma Limited, India Instaclop Plus Capsules Clopidogrel Bisulphate 220 USP 75mg Metoprolol Succinate POM Tablet extended 115/091 Ajanta Pharma Limited, India Met-XL 100 Tablets 221 100mg release Adapalene 0.1% w/w + POM 115/092 Adacin Gel Gel Topical Ajanta Pharma Limited, India 222 Clindamycin 1% w/w Moxifloxacin + POM 115/093 Addrops DX Eye Drops Eye Drops Ajanta Pharma Limited, India 223 Dexamethasone Artemether 80mg + POM 115/094 Artefan 80/480 Tablets Tablet Film Coated Ajanta Pharma Limited, India 224 Lumefantrine 480 mg Tritinoin 0.025%w/w + POM 115/095 Mometasone Furoate Melacare Cream 15mg Cream Topical Ajanta Pharma Limited, India 0.1%w/w + Hydroquinone 225 2% w/w 226 Ajanta's Stamina Herbal Extract P Capsule oral 115/HM008 Ajanta Pharma Limited, India Gentamicin + POM Ear/Eye Drops 158/001 Alcon Cusi SA Spain Colirucus Gentadexa Ear/Eye Dexamethasone + Drops Tetryzoline 227 (0.65mg/100ml) Trimethoprim + POM Eye Drops 158/002 Alcon Cusi SA Spain Oftalmotrin Eye Drops 228 Polymyxin B (1.1g) Sodium Cromoglycate POM Eye Drops 158/003 Alcon Cusi SA Spain Curicrom Eye Drops 229 2% w/v Disodium cromoglycate POM Eye Drops 158/004 Alcon Cusi SA Spain Cusicrom Eye Drops 230 4% w/v Colircusi Chloramphenicol Eye Chloramphenicol 0.5% POM Eye Drops 158/005 Alcon Cusi SA Spain 231 Drops 232 Cusimolol Eye Drops Timolol 0.5% w/v POM Eye Drops 158/006 Alcon Cusi SA Spain Sodium Cromoglycate POM Eye Drops 009/004 Alcon Laboratories SA Pty Ltd Cusicrom 4% Eye Drops 233 4% w/v cyclopentolate POM Eye Drops 009/024 Alcon Laboratories SA Pty Ltd Cyclogyl 15 Eye Drops 234 Hydrochloride 1% w/v Dexamethasone 0.1% POM Ointment topical 009/031 Alcon Laboratories SA Pty Ltd Maxidex Ointment 235 w/w

Page 12 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Neomycin sulphate POM Ointment topical 009/033 Alcon Laboratories SA Pty Ltd 3,500IU + Maxitrol Ointment Dexamethasone 1mg + Polymyxin B sulphate 236 6,000 IU 237 Mydriacyl Eye Drops Tropicamide 0.5% w/v POM Solution 009/034 Alcon Laboratories SA Pty Ltd Naphazoline POM Eye Drops 009/035 Alcon Laboratories SA Pty Ltd Hydrochloride 0.025% + Naphcon Eye Drops Pheniramine maleate 238 0.3% 239 Tetracaine 0.5% Eye Drops Lignocaine 0.5% w/v POM Eye Drops 009/037 Alcon Laboratories SA Pty Ltd 240 Tobrex Ointment Tobramycin 0.3% w/v POM Ointment topical 009/039 Alcon Laboratories SA Pty Ltd Tobramycin 0.3% + POM Ointment topical 227/001 Alcon Laboratories SA Pty Ltd Tobradex Ointment 241 Dexamethasone 0.1% Tobramycin 0.3% + POM Eye Drops 227/002 Alcon Laboratories SA Pty Ltd Tobradex Eye Drops 242 Dexamethasone 0.1% Bromhexine 4.2mg + P Solution for Oral 215/001 Alembic Chemical Works Co. Limited, India Brozeet Solution Terbutaline 1.575mg, per Use 243 5ml Benzathine Penicillin 2.4 MU Benzathine Penicillin 2.4 POM Powder for 215/002 Alembic Chemical Works Co. Limited, India 244 Injection Mega Units Injection Bromhexine 4mg + P Syrup 215/003 Alembic Chemical Works Co. Limited, India Guaiphenesin 50mg + Zeet Expectorant Syrup Diphenylhydramine 8mg, 245 per 5ml Clarithromycin 250mg POM Tablet Uncoated 215/004 Alembic Chemical Works Co. Limited, India Clarithro-250 Tablets 246 Codeine Phosphate P Syrup 215/005 Alembic Chemical Works Co. Limited, India 3.75mg + Alcohol 10mg + Glycodin Cough Syrup Menthol 0.07ml + Terpene Hydrate 10mg 247 per 5ml Loratadine 10mg POM Tablet Uncoated 215/006 Alembic Chemical Works Co. Limited, India Lomeg 10 Tablets 248 Procaine Penicillin 3MU POM Powder for 215/007 Alembic Chemical Works Co. Limited, India Procain Penicillin 3MU Injection 249 Injection Fortified Procaine Penicillin Procain Penicillin 4MU POM Powder for 215/008 Alembic Chemical Works Co. Limited, India 250 4MU Injection Injection

Page 13 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Benzyl Penicillin 5MU POM Powder for 215/009 Alembic Chemical Works Co. Limited, India Benzyl Penicillin 5MU Injection 251 Injection Sparfloxacin 200mg POM Tablet Uncoated 215/010 Alembic Chemical Works Co. Limited, India Sparta Tablets 252 Azithromycin 200mg POM Solution for Oral 215/011 Alembic Chemical Works Co. Limited, India Azithral 200 Liquid 253 Use Azithromycin 2050mg POM Solution for Oral 215/012 Alembic Chemical Works Co. Limited, India Althrocin S 250 Oral Solution 254 Use Omeprazole 20mg POM Capsule oral 215/013 Alembic Chemical Works Co. Limited, India Omezol-20 Capsules 255 Ciprofloxacin 500mg POM Tablet Uncoated 215/014 Alembic Chemical Works Co. Limited, India Ciprown-500 Tablets 256 Azithromycin 250mg POM Tablet Uncoated 215/015 Alembic Chemical Works Co. Limited, India Azithral-250 Tablets 257 Magaldrate 84mg + POM Suspension for 215/016 Alembic Chemical Works Co. Limited, India Ugel Liquid Simethicone 4.080mg, Oral Use 258 per ml Magaldrate 400mg + P Tablet Chewable 215/017 Alembic Chemical Works Co. Limited, India Ugel Chewable Tablets 259 Simethicone 20mg Aceclofenac 100mg POM Tablet Film coated 215/018 Alembic Chemical Works Co. Limited, India Fortafen Tablets 260 Azithromycin Dihydrate POM Tablet Film coated 215/019 Alembic Chemical Works Co. Limited, India Azithral - 500 Tablets 261 500mg Glimepiride USP 2mg + POM Tablet Film coated 215/020 Alembic Chemical Works Co. Limited, India Glisen MF 2 Tablets Metformin Hydrochloride 262 USP 500mg Glimepiride USP 1mg + POM Tablet Film coated 215/021 Alembic Chemical Works Co. Limited, India Glisen MF 1 Tablets Metformin Hydrochloride 263 USP 500mg Olopatadine POM Eye Drops 215/022 Alembic Chemical Works Co. Limited, India Neolap Eye Drops Hydrochloride USP 0.2% 264 w/v Moxifloxacin POM Eye Drops 215/023 Alembic Chemical Works Co. Limited, India Moxofi Eye Drops 265 Hydrochloride 5.4mg Doizolamide HCl USP POM Eye Drops 215/024 Alembic Chemical Works Co. Limited, India Dorembic Eye Drops 266 2.0%w/v Dozolamide Hcl USP 2% POM Eye Drops 215/025 Alembic Chemical Works Co. Limited, India Augdor Eye Drops w/v + Timolol maleate 267 USP 0.5%w/v

Page 14 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Carboxymethylcellulose POM Eye Drops 215/026 Alembic Chemical Works Co. Limited, India Vel Drop Gel 268 Sodium 1%/w/v Tobramycin USP POM Solution for Topical 215/027 Alembic Chemical Works Co. Limited, India Alemtob Eye Drops 269 0.3%w/v Use Tobramycin 0.3%w/v + POM Solution for Topical 215/028 Alembic Chemical Works Co. Limited, India Alemtob-D Eye Drops Dexamethasone 0.1%w/v Use 270 Ofloxacin 0.3%w/v + POM Solution for Topical 215/029 Alembic Chemical Works Co. Limited, India Owin D Eye Drops Dexamethasone 0.1%w/v Use 271 Carboxymethylcellulose POM Eye Drops 215/030 Alembic Chemical Works Co. Limited, India Vel Eye Drops 272 Sodium 0.5%w/v 273 Erythromycin Tablets Erythromycin 250mg POM Tablet Uncoated 166/001 Alkem Laboratories Ltd, India Erythromycin 125mg, per POM Suspension for 166/002 Alkem Laboratories Ltd, India Erythromycin Suspension 274 5ml Oral Use 275 Broadmex-250 Capsules Amoxicillin 250mg POM Capsule oral 166/003 Alkem Laboratories Ltd, India 276 Formin-500mg Tablets Metformin 500mg POM Tablet Uncoated 166/004 Alkem Laboratories Ltd, India 277 Cloxacillin Capsules Cloxacillin 250mg POM Capsule oral 166/005 Alkem Laboratories Ltd, India Cefotaxime 1g POM Powder for 166/006 Alkem Laboratories Ltd, India Taxim 1g Injection 278 Injection Cephalexin 125mg, per POM Powder for Oral 166/007 Alkem Laboratories Ltd, India Decacef Suspension 279 5ml Suspension 280 Decacef 500 Capsules Cephalexin 500mg POM Capsule oral 166/008 Alkem Laboratories Ltd, India Chloramphenicol Oral Chloramphenicol 125mg, POM Suspension for 166/009 Alkem Laboratories Ltd, India 281 Suspension per 5ml Oral Use 282 Alcipro 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 166/010 Alkem Laboratories Ltd, India Amoxicillin 125mg, per POM Powder for Oral 166/011 Alkem Laboratories Ltd, India Amoxicillin Suspension 283 5ml Suspension Ampicillin 125mg, per POM Suspension for 166/012 Alkem Laboratories Ltd, India Anpicillin Oral Suspension 284 5ml Oral Use Cloxacillin 125mg, per POM Powder for Oral 166/013 Alkem Laboratories Ltd, India Cloxacillin Oral Suspension 285 5ml Suspension 286 Omeprazole-20 Capsules Omeprazole 20mg POM Capsule oral 166/014 Alkem Laboratories Ltd, India Trimethoprim 80mg + POM Tablet Uncoated 166/015 Alkem Laboratories Ltd, India T-Prim 80/400mg Tablets Sulfamethoxazole 400mg 287 Cloxacillin 250mg POM Powder for 166/016 Alkem Laboratories Ltd, India Cloxacillin 250 Injection 288 Injection 289 Decacef 250 Capsules Cephalexin 250mg POM Capsule oral 166/017 Alkem Laboratories Ltd, India

Page 15 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Ampicillin + Cloxacillin POM Capsule oral 166/018 Alkem Laboratories Ltd, India Broadclox-500 Capsules 290 500mg Amitriptylline POM Tablet Uncoated 252/001 Alpharma Ltd, United Kingdom Amitriptylline Tablets 291 Hydrochloride 25mg 292 Allopurinol Tablets Allopurinol 100mg POM Tablet Uncoated 252/002 Alpharma Ltd, United Kingdom 293 Atenolol 25 Tablets Atenolol 25mg POM Tablet Film coated 252/003 Alpharma Ltd, United Kingdom 294 Atenolol 50 Tablets Atenolol 50mg POM Tablet Film coated 252/004 Alpharma Ltd, United Kingdom 295 Atenolol Tablets Atenolol 100mg POM Tablet Film coated 252/005 Alpharma Ltd, United Kingdom 296 Bendrofluazide Tablets Bendrofluazide 5mg POM Tablet Uncoated 252/006 Alpharma Ltd, United Kingdom 297 Captopril Tablets Captopril 25mg POM Tablet Uncoated 252/007 Alpharma Ltd, United Kingdom Hydrochlorothiazide POM Tablet Uncoated 252/008 Alpharma Ltd, United Kingdom Co-Amilozide Tablets 298 50mg + Amiloride 5mg 299 Glibenclamide Tablets Glibenclamide 5mg POM Tablet Uncoated 252/009 Alpharma Ltd, United Kingdom 300 Glyceryl Trinitrate Tablets Glyceryl Trinitrate 0.5mg POM Tablet Uncoated 252/010 Alpharma Ltd, United Kingdom Isosorbide mononitrate POM Tablet Uncoated 252/011 Alpharma Ltd, United Kingdom Isosorbide Mononitrate Tablets 301 10mg 302 Metformin Tablets Metformin 500mg POM Tablet Uncoated 252/012 Alpharma Ltd, United Kingdom Verapamil Hydrochloride POM Tablet Uncoated 252/013 Alpharma Ltd, United Kingdom Verapamil Tablets 303 40mg 304 Spironolactone 25 Tablets Spironolactone 25mg POM Tablet Uncoated 252/014 Alpharma Ltd, United Kingdom 305 Spironolactone 50 Tablets Spironolactone 50mg POM Tablet Uncoated 252/015 Alpharma Ltd, United Kingdom 306 Contempo Bareback Condom Latex Condom GS Protective barrier 439/001L Alston Garrard uk Contempo Erotica Ribbed Latex Condom GS Protective barrier 439/002L Alston Garrard uk 307 Condom 308 Contempo Flavours Condoms Latex Condom GS Protective barrier 439/003L Alston Garrard uk 309 Contempo King Size Condoms Latex Condom GS Protective barrier 439/004L Alston Garrard uk Contempo Power Play Condom Latex Condom GS Protective barrier 439/005L Alston Garrard uk 310 Contempo Rough Rider Latex Condom GS Protective barrier 439/006L Alston Garrard uk 311 Condom Contempo Wet N Wild Condom Latex Condom GS Protective barrier 439/007L Alston Garrard uk 312 313 Lifestyle Fantasy Condom Latex Condom GS Protective barrier 439/008L Alston Garrard uk 314 Lifestyles sensations Condom Latex Condom GS Protective barrier 439/009L Alston Garrard uk 315 Lifestyles Sensitive Condom Latex Condom GS Protective barrier 439/010L Alston Garrard uk Ascorbic Acid 500 + P Tablet Uncoated 020/003 Amoun Pharmaceuticals Company, Egypt Amovit C Calcium Tablets 316 Calcium Carbonate 1000 317 Amovit C Tablets Ascorbic Acid 1000mg P Tablet Uncoated 020/004 Amoun Pharmaceuticals Company, Egypt

Page 16 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Benzocaine 1500 mg+ GS Spray for Topical 020/005 Amoun Pharmaceuticals Company, Egypt Benzydamine Use B.B.C Spray hydrochloride 150mg + Cetalkonium chloride, per 318 100ml Olive Oil 10mg + Zinc GS Cream Topical 020/006 Amoun Pharmaceuticals Company, Egypt Baby Cream 319 Oxide 20mg, per 100g Sodium Cromoglycate POM Eye Drops 020/007 Amoun Pharmaceuticals Company, Egypt Collycrom 4% Eye Drops 320 4.0% w/v Monosodium phosphate POM Solution for Topical 020/008 Amoun Pharmaceuticals Company, Egypt Enemax Enema Solution 6mg + Disodium Use 321 phosphate 16mg Sodium Bicarbonate GS Granules for Oral 020/009 Amoun Pharmaceuticals Company, Egypt Xenos Fruit Effervescent 2.7mg + Citric Acid Use Granules 0.76mg + Tartaric Acid 322 1.257mg 323 For Hair and Nails Capsules GS Capsule oral 020/010 Amoun Pharmaceuticals Company, Egypt Glucose 3mg+ Ascorbic GS Tablet Uncoated 020/011 Amoun Pharmaceuticals Company, Egypt Glucose Tablets 324 Acid 120mg Paracetamol 400mg+ P Tablet Uncoated 020/012 Amoun Pharmaceuticals Company, Egypt Pseudoephedrine 60mg Michaelon Tablets + Carbinoxaine Maleate 325 4mg Bisacodyl 3mg + Dioctyl - P Tablet Uncoated 020/013 Amoun Pharmaceuticals Company, Egypt Minalax Tablets Sodium Sulphosuccinate 326 100mg Dill Oil + Caraway Oil + GS Syrup 020/014 Amoun Pharmaceuticals Company, Egypt My Sweet Baby Syrup Cardamon Oil + 327 Peppermint Oil Multivitamin GS Capsule oral 020/015 Amoun Pharmaceuticals Company, Egypt Vitamount for Women Capsules 328 329 Vitamount Syrup Multivitamin GS Syrup 020/016 Amoun Pharmaceuticals Company, Egypt Melatonin + Pyrodoxine POM Tablet Uncoated 020/017 Amoun Pharmaceuticals Company, Egypt Viva-Max 3mg Tablets 330 Hcl 3mg Bevacizumab Amring 400mg/ Bevacizumab 440mg/4ml POM Solution for 441/002 Amring Farma SRL 331 4ml Injection Paracetamol Amring Infusion Paracetamol 10mg/ml POM Solution for 441/004 Amring Farma SRL 332 infusion

Page 17 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Zoledronic Acid Amring Infusion Zoledronic Acid 0.8mg/ml POM Solution for 441/003 Amring Farma SRL 333 infusion Bevacizumab Amring 100mg/ Bevacizumab 25mg/ml POM Solution for 441/001 Amring Farma SRL 334 4ml Injection 335 Safe Pill Levonorgestrel 1.5mg P Tablet Film coated 404/001 Anant Pharmaceuticals Ltd Vitamin B12 2500mcg, POM Solution for 279/001 Anglo-French Drugs & Industries Ltd,India Folic acid 0.7mg, Injection Enerject-12 Injection Niacinamide 12 mg, 336 Benzyl Alcohol 1% v/v Vit B Complex + Vit C+ GS Tablet Film coated 279/002 Anglo-French Drugs & Industries Ltd,India Beplex Forte Tablets 337 Biotin 260mcg Multivitamin POM Solution for 279/003 Anglo-French Drugs & Industries Ltd,India Beplex Forte Injection 338 Injection 339 Maxamin Forte Tablets Vitamins + Minerals GS Tablet Uncoated 279/004 Anglo-French Drugs & Industries Ltd,India 340 Zincofer Capsules Haematinic preparation P Capsule oral 248/001 Apex Laboratories Ltd, India Betamethasone POM Cream Topical 248/002 Apex Laboratories Ltd, India Betzee Cream 0.05%w/w + Zinc 341 2.5%w/w Betamethasone POM Cream Topical 248/003 Apex Laboratories Ltd, India 0.05%w/w + Gentamicin Betzee G Cream 0.10%w/w+ Zinc 342 2.5%w/w Betamethasone POM Cream Topical 248/004 Apex Laboratories Ltd, India Betzee-M Cream 0.05%w/w + Miconazole 343 2%w/w + Zinc 2.5%w/w Betamethasone POM Cream Topical 248/005 Apex Laboratories Ltd, India 0.05%w/w+ Betzee-GM Cream Miconazole2%w/w + Gentamicin 0.10%w/w+ 344 Zinc 2.5%w/w Betamethasone0.05%w/ POM Ointment topical 248/006 Apex Laboratories Ltd, India Betzee-S Ointment w + Salicylic acid 345 3%w/w+ Zinc 2.5%w/w 346 Lozee Cream clobetasone 0.05% w/w POM Cream Topical 248/007 Apex Laboratories Ltd, India Clobetasone 0.05% + POM Cream Topical 248/008 Apex Laboratories Ltd, India Gentamicin 0.10% + Lozee-GM Cream Miconazole 2.0% + Zinc 347 1.0%w/w

Page 18 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Multivitamins GS Syrup for Oral Use 248/009 Apex Laboratories Ltd, India Zincovit Syrup 348 349 Zincovit Tablets Multivitamins GS Tablet Uncoated 248/010 Apex Laboratories Ltd, India Multivitamins GS Suspension for 248/011 Apex Laboratories Ltd, India Zincovit Drops 350 Oral Use Haematinic preparation P Suspension for 248/012 Apex Laboratories Ltd, India Zincofer Liquid 351 Oral Use 352 Nalidixic Acid Tablets Nalidixic acid 500mg POM Tablet Uncoated 248/013 Apex Laboratories Ltd, India 353 Monocef-O Tablets Cefpodoxine 200mg POM Tablet Uncoated 256/001 Aristo Pharmaceuticals Ltd, India 354 Tobacin Eye Drops Tobramycin 0.3% w/v POM Eye Drops 256/003 Aristo Pharmaceuticals Ltd, India Ampicillin 125mg, per POM Powder for 187/001 Arubhi International, India Ar- Ampi Powder 355 5ml suspension 356 Ar-Grisco 125mg Tablets Griseofulvin 125mg POM Tablet Uncoated 187/002 Arubhi International, India 357 Ar-Griseo 250 Tablets Griseofulvin 250mg POM Tablet Uncoated 187/003 Arubhi International, India Ampicillin 250mg + POM Capsule Oral 187/004 Arubhi International, India Ar-Ampicloc Capsules 358 Cloxacillin 250mg Ampicillin 62.5mg + POM Syrup 187/005 Arubhi International, India Ar-Ampiclox 125 Syrup 359 Cloxacillin 62.5mg 360 Ar-Clovir Tablets Acyclovir 200mg POM Tablet Uncoated 187/006 Arubhi International, India 361 Ar-Clox Capsules Cloxacillin 250mg POM Capsule Oral 187/009 Arubhi International, India Cloxacillin 125mg, per POM Syrup 187/010 Arubhi International, India Ar-Cloxa Syrup 362 5ml 363 Ar-Fol 5 Tablets Folic acid 5mg P Tablet Uncoated 187/011 Arubhi International, India Sodium chloride + GS Powder for Oral 187/012 Arubhi International, India Sodium citrate + Possium Solution Arol Solution chloride + Glucose 364 365 Ar-Cetamol Tablets Paracetamol 500mg P Tablet Uncoated 187/013 Arubhi International, India 366 Ar-Sal Tablets Salbutamol 4mg POM Tablet Uncoated 187/014 Arubhi International, India 367 Ar-Ibu Tablets Ibuprofen 200mg P Tablet Film coated 187/015 Arubhi International, India 368 Ar-Zole Capsules Fluconazole 150mg POM Capsule oral 187/016 Arubhi International, India 369 Ar-Ozine Tablets Promethazine 25mg P Tablet Film coated 187/017 Arubhi International, India Trimethoprim 80mg + POM Tablet Uncoated 187/018 Arubhi International, India Ar-Cotri Tablets Sulphamethoxazole 370 400mg Pyrantel pamoate 125mg P Tablet Uncoated 187/019 Arubhi International, India Ar-Pyra Tablets 371 372 Ar Cee Tablets Ascorbic Acid 200mg GS Tablet Uncoated 187/020 Arubhi International, India 373 Ar-Gliben - 5 Tablets Glibenclamide 5mg POM Tablet Uncoated 187/021 Arubhi International, India

Page 19 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 374 Ar-Pred Tablets Prednisolone 5mg POM Tablet Uncoated 187/022 Arubhi International, India Pyrimethamine 25mg + P Tablet Uncoated 187/023 Arubhi International, India Ar-Dar Tablets 375 Sulphadoxine 500mg 376 Ar-Peridol Tablets Haloperidol 5mg POM Tablet Uncoated 187/024 Arubhi International, India 377 Ar-Omycin Tablets Erythromycin 250mg POM Tablet Uncoated 187/025 Arubhi International, India 378 AR-Zole Capsules Fluconazole 200mg POM Capsule Oral 187/026 Arubhi International, India 379 Ar-Floxacin Tablets Ciprofloxacin 500mg POM Tablet Film coated 187/027 Arubhi International, India 380 Ar-Tetra Capsules Tetracycline 250mg POM Capsule Oral 187/028 Arubhi International, India 381 Ar-Diclo Tablets Diclofenac 100mg P Tablet Uncoated 187/029 Arubhi International, India 382 Ar- Pramide Tablets Loperamide 2mg POM Tablet Uncoated 187/030 Arubhi International, India 383 Ar-Mazepine Tablets Carbamazepine 200mg POM Tablet Uncoated 187/031 Arubhi International, India 384 Ar-Thylodopa Tablets Methyldopa 250mg POM Tablet Film coated 187/032 Arubhi International, India Aluminium hydroxide BP GS Tablet Chewable 187/033 Arubhi International, India Ar-Antacid Tablets 120mg + Magnesium 385 trisilscate BP 250mg Hyoscine Butybromide POM Tablet Uncoated 187/034 Arubhi International, India Ar-Hyoscine Tablets 386 10mg 387 Ar-Grisceo 500 Tablets Griseofulvin 500mg POM Tablet Uncoated 187/035 Arubhi International, India 388 Ar-Metro Tablets Metronidazole 200mg POM Tablet Uncoated 187/036 Arubhi International, India 389 Ar-Vitacee Tablets Ascorbic Acid 100mg GS Tablet Uncoated 187/037 Arubhi International, India 390 Arbimazole Tablets Carbimazole 5mg POM Tablet Uncoated 187/038 Arubhi International, India 391 Ardidol Tablets Propranolol 40mg POM Tablet Uncoated 187/039 Arubhi International, India 392 Arhexol 2mg Tablets Benzhexol 2mg POM Tablet Uncoated 187/040 Arubhi International, India 393 Arhexol 5mg Tablets Benzhexol 5mg POM Tablet Uncoated 187/041 Arubhi International, India 394 Arnadix Tablets Nalidixic Acid 500mg POM Tablet Uncoated 187/042 Arubhi International, India 395 Arphen Tablets Chlorpheniramine 4mg P Tablet Uncoated 187/043 Arubhi International, India 396 Artopril Tablets Captopril 25mg POM Tablet Uncoated 187/044 Arubhi International, India 397 Paradol Tablets Paracetamol 500mg GS Tablet Uncoated 187/045 Arubhi International, India Pyrantel Pamoate 50mg, P Suspension for 187/046 Arubhi International, India Ar-Pyron Suspension 398 per 1ml Oral Use 399 AR-INDO 25 Capsules Indomethacin 25mg P Capsule oral 187/047 Arubhi International, India 400 Ar-Ampi 250 Caspules Ampicillin 250mg POM Capsule oral 187/048 Arubhi International, India 401 Ar-Amox 250 Capsules Amoxicillin 250mg POM Capsule oral 187/049 Arubhi International, India 402 Diclonac Tablets Diclofenac 50mg P Tablet Uncoated 187/050 Arubhi International, India 403 Formin Tablets Metformin 500mg POM Tablet Uncoated 187/051 Arubhi International, India 404 Sharp Shoot Tablets Sildenafil 50mg POM Tablet Uncoated 187/052 Arubhi International, India 405 Sharp Shoot Tablets Sildenafil 100mg POM Tablet Uncoated 187/053 Arubhi International, India 406 Aramino Tablets Aminophylline 100mg POM Tablet Uncoated 187/054 Arubhi International, India 407 Armide Tablets Furosemide 40mg POM Tablet Uncoated 187/055 Arubhi International, India

Page 20 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Aspirin 75mg POM Tablet Sustained 187/056 Arubhi International, India Ar-Pirin Tablets 408 Release 409 Chloprazin Tablets Chlorpromazine 25mg POM Tablet Uncoated 187/057 Arubhi International, India 410 Cimedin Tablets Cimetidine 200mg POM Tablet Uncoated 187/058 Arubhi International, India 411 Digox Tablets Digoxin 0.25mg POM Tablet Uncoated 187/059 Arubhi International, India 412 Vita - B6 Tablets Pyridoxine 50 mg POM Tablet Uncoated 187/060 Arubhi International, India 413 Griseofulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 184/001 Arvind Remedies Limited, India 414 Cloxacillin Capsules Cloxacillin 250mg POM Capsule Oral 184/002 Arvind Remedies Limited, India 415 Phenobarbital Tablets Phenobarbitone 30mg POM Tablet Uncoated 184/003 Arvind Remedies Limited, India Rifampicin 150mg+ POM Tablet Uncoated 184/004 Arvind Remedies Limited, India Rifampicin + Isoniazid Tablets 416 Isoniazid 75mg 417 Propranolol Tablets Propranolol 40mg POM Tablet Uncoated 184/005 Arvind Remedies Limited, India 418 Promethazine Tablets Promethazine 25mg P Tablet Uncoated 184/006 Arvind Remedies Limited, India 419 Methyldopa Tablets Methyldopa 250mg POM Tablet Uncoated 184/007 Arvind Remedies Limited, India Diclofenac BP Enteric Coated Diclofenac 50mg P Tablet Enteric 184/008 Arvind Remedies Limited, India 420 Tablets Coated Sulfadoxine USP + Pyrimethamine 25mg + P Tablet Uncoated 184/010 Arvind Remedies Limited, India 421 Pyrimethamine Tablets Sulfadoxine USP 500mg 422 Suganril Tablets Piroxicam 20mg POM Tablet Uncoated 101/001 Asence Pharma Pvy Ltd., India. Diclofenac 75mg, per 3ml POM Solution for 101/002 Asence Pharma Pvy Ltd., India. Zodid Injection 423 Injection 424 Zobid SR Tablets Diclofenac 100mg P Tablet Uncoated 101/003 Asence Pharma Pvy Ltd., India. 425 Nifedipine 10 Tablets Nifedipine 10mg POM Tablet Uncoated 101/004 Asence Pharma Pvy Ltd., India. Penicillin G + Procaine POM Powder for 101/005 Asence Pharma Pvy Ltd., India. Pocilin 4 Mega Injection 426 Benzylpenicillin 4MU Injection B Complex POM Solution for 101/006 Asence Pharma Pvy Ltd., India. Trimin Injection 427 Injection Amoxicillin 25mg, per 5ml POM Powder for Oral 101/007 Asence Pharma Pvy Ltd., India. Amoxicillin Oral Suspension 428 Suspension Aluminium hydroxide 120 GS Tablet Uncoated 101/008 Asence Pharma Pvy Ltd., India. Compound Magnesium Tablets + Magnesium trisilscate 429 250mg Codein 10mg + P Syrup 101/009 Asence Pharma Pvy Ltd., India. Cofnil-N Expectorant Syrup Chlorpheniramine 4mg + 430 Methol 1.5mg, per 5ml Amphotericin B 5mg POM Solution for 101/010 Asence Pharma Pvy Ltd., India. Amphotericin B Injection 431 Injection Streptomycin 5 g POM Powder for 101/011 Asence Pharma Pvy Ltd., India. Streptocin Injection 432 Injection

Page 21 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 433 Amoxicillin Trihydrate Capsules Amoxicillin 250mg POM Capsule oral 101/012 Asence Pharma Pvy Ltd., India. 434 Hemomin Capsules Haemantic preparation P Capsule oral 101/013 Asence Pharma Pvy Ltd., India. Sodium Chloride + GS Powder for Oral 101/014 Asence Pharma Pvy Ltd., India. Sodium Citrate + Solution Oral Rehydration Salt Possium Chloride + 435 Glucose Phenoxymethyl Penicillin V Phenoxymethyl Penicillin POM Tablet Uncoated 101/015 Asence Pharma Pvy Ltd., India. 436 Tablets V 250mg Fluphenazine Decanoate Fluphenazine 25mg POM Solution for 101/017 Asence Pharma Pvy Ltd., India. 437 Injection Injection Sulphacetamide 75mg + POM Powder for Topical 101/018 Asence Pharma Pvy Ltd., India. Sulphabiotic Dusting Powder Neomycin 5mg + use 438 Gramicidin 0.5mg 439 Tetracycline Eye Ointment Tetracycline 1%w/w POM Eye Ointment 101/019 Asence Pharma Pvy Ltd., India. 440 Neuclar - 500 Tablets Clarithromycin 500mg POM Tablet Uncoated 101/020 Asence Pharma Pvy Ltd., India. Nifedipine 20mg POM Tablet extended 101/021 Asence Pharma Pvy Ltd., India. Nipine SR Tablets 441 release Thiamine Mononitrate P Tablet Film coated 101/022 Asence Pharma Pvy Ltd., India. USP 100mg + Pyridoxine Hydrochloride BP30mg + Trimin Tablets Cyanocobalamine 100mcg 442 Thiamine Mononitrate P Tablet Film coated 101/023 Asence Pharma Pvy Ltd., India. 10mg + Riboflavine + Maxiplex Tablets Pyridoxine Hydrochloridel + Niacinamide 443 444 Quinine Sulphate Tablets Quinine Sulphate 300mg POM Tablet Uncoated 145/001 Aspen Pharmacare Limited, South Africa Hydrochlorothiazide POM Tablet Uncoated 145/002 Aspen Pharmacare Limited, South Africa Amiloretic H.S Tablets 445 2.5mg + Amiloride 25mg 446 Arthrexin 25 Suppositories Indomethacin 25mg P Suppository 145/003 Aspen Pharmacare Limited, South Africa Diclofenac 100mg P Tablet Film coated, 145/005 Aspen Pharmacare Limited, South Africa Panamor 100 SR Tablets Sustained Release 447 Sulphamethoxazole POM Tablet Uncoated 145/006 Aspen Pharmacare Limited, South Africa Purbac Adult Tablets 400mg + Trimethoprim 448 80mg 449 Purata -10 Tablets Oxazepam 10mg POM Tablet Uncoated 145/007 Aspen Pharmacare Limited, South Africa

Page 22 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 450 Pur-Bloka Tablets Propranolol 40mg POM Tablet Uncoated 145/008 Aspen Pharmacare Limited, South Africa Codeine 10mg + P Tablet Uncoated 145/009 Aspen Pharmacare Limited, South Africa Mybulen Tablets Paracetamol 350mg + 451 Ibuprofen 200mg 452 Degramol 200 Tablets Carbamazepine 200mg POM Tablet Uncoated 145/010 Aspen Pharmacare Limited, South Africa 453 Arthrexin-100 Suppositories Indomethacin 100mg P Suppository 145/011 Aspen Pharmacare Limited, South Africa 454 Wormgo Tablets Mebendazole 100mg P Tablet Uncoated 145/013 Aspen Pharmacare Limited, South Africa 455 Cardifen-10 Capsules Nifedipine 10mg POM Capsule oral 145/014 Aspen Pharmacare Limited, South Africa Salbutamol 2mg, per 5ml POM Syrup 145/015 Aspen Pharmacare Limited, South Africa Venteze Syrup 456 Salbutamol 100mcg POM Powder for 145/016 Aspen Pharmacare Limited, South Africa Venteze Inhaler 457 Inhalation Erythromycin 125mg, per POM Suspension for 145/017 Aspen Pharmacare Limited, South Africa Purmycin 125 Suspension 458 5ml Oral Use 459 Hypotone Tablets Methyldopa 250mg POM Tablet Uncoated 145/018 Aspen Pharmacare Limited, South Africa 460 Trichazole Tablets Metronidazole 5mg POM Tablet Uncoated 145/020 Aspen Pharmacare Limited, South Africa 461 Glycomin Tablets Glibenclamide 5mg POM Tablet Uncoated 145/021 Aspen Pharmacare Limited, South Africa Amiloride Hydrochloride POM Tablet Uncoated 145/022 Aspen Pharmacare Limited, South Africa Amiloretic Tablets 462 50mg Sodium Bicarbonate + GS Solution for Oral 145/023 Aspen Pharmacare Limited, South Africa Woodward's Gripe Water 463 Dill oil Use 464 Lenisolone Tablets Prednisolone 5mg POM Tablet Uncoated 145/024 Aspen Pharmacare Limited, South Africa 465 AP Stavudine15 Capsules Stavudine 15mg POM Capsule oral 145/025 Aspen Pharmacare Limited, South Africa Lamivudine 150mg + POM Tablets 145/029 Aspen Pharmacare Limited, South Africa Aspen Lamizid Tablets 466 Zidovudine 300mg 467 Aspen Lamivudine Tablets Lamivudine 150mg POM Tablet Uncoated 145/030 Aspen Pharmacare Limited, South Africa Lamivudine 10mg, per ml POM Syrup 145/031 Aspen Pharmacare Limited, South Africa Aspen Lamivudine Syrup 468 469 Aspen Zidovudine Tablets Zidovudine 300mg POM Tablet Uncoated 145/032 Aspen Pharmacare Limited, South Africa Zidovudine 50mg, per POM Syrup 145/033 Aspen Pharmacare Limited, South Africa Aspen Zidovudine Syrup 470 5ml 471 Aspen Nevirapine Tablets Nevirapine 200mg POM Tablet Uncoated 145/034 Aspen Pharmacare Limited, South Africa Lamivudine 150mg + POM Tablet Uncoated 145/035 Aspen Pharmacare Limited, South Africa Aspen Lamzid + Nevirapine Zidovudine Combipack Tablets 300mg/Nevirapine 472 200mg Aspen Didanosine 50mg Didanosine 50mg POM Tablet Uncoated 145/036 Aspen Pharmacare Limited, South Africa 473 Tablets

Page 23 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Aspen Didanosine 100mg Didanosine 100mg POM Tablet Uncoated 145/037 Aspen Pharmacare Limited, South Africa 474 Tablets Aspen Didanosine 150mg Didanosine 150mg POM Tablet Uncoated 145/038 Aspen Pharmacare Limited, South Africa 475 Tablets 476 Viread Tablets Tenofovir 300mg POM Tablet Film coated 145/039 Aspen Pharmacare Limited, South Africa Emtricitabine 200mg + POM Tablet Film coated 145/040 Aspen Pharmacare Limited, South Africa Truvada Tablets 477 Tenofovir 300mg Aspen Didanosine 25mg Didanosine 25mg POM Tablet Uncoated 145/041 Aspen Pharmacare Limited, South Africa 478 Tablets 479 Prezista Tablets Darunavir 300mg POM Tablet Uncoated 145/042 Aspen Pharmacare Limited, South Africa 480 Intelence Tablets Etravirine 100mg POM Tablet Uncoated 145/043 Aspen Pharmacare Limited, South Africa 481 Prezista Tablets Darunavir 600mg POM Tablet Film coated 145/044 Aspen Pharmacare Limited, South Africa Hydrocortisone 100mg POM Powder for 145/045 Aspen Pharmacare Limited, South Africa Hycorcin 100mg Injection 482 Injection Escitalopram oxalate POM Tablet Film coated 145/046 Aspen Pharmacare Limited, South Africa Isolift 10mg Tablets 483 10mg Escitalopram oxalate POM Tablet Film coated 145/047 Aspen Pharmacare Limited, South Africa Isolift 20mg Tablets 484 20mg Atracurium 10mg, per ml POM Solution for 179/024 Aspen Pharmacare Limited, South Africa Tracruim Injection 485 Injection 486 Lanoxin Tablets Digoxin 0.25mg POM Tablet Uncoated 179/029 Aspen Pharmacare Limited, South Africa 487 Topilept 25 Tablets Topiramate 25mg POM Tablet Film coated 179/053 Aspen Pharmacare Limited, South Africa 488 Topilept 50 Tablets Topiramate 50mg POM Tablet Film coated 179/054 Aspen Pharmacare Limited, South Africa 489 Topilept 100 Tablets Topiramate 100mg POM Tablet Film coated 179/055 Aspen Pharmacare Limited, South Africa Cisatracurium besylate POM Solution for 179/060 Aspen Pharmacare Limited, South Africa Nimbex Injection 490 2mg, per ml Injection 491 Lanzine (ODT) Tablets Olanzepine 10mg POM Tablet Film coated 179/070 Aspen Pharmacare Limited, South Africa Ramipril BP 5mg + POM 179/070 Co-Rampil Tablets Hydrochlorothiazide USP Tablet Uncoated Aspen Pharmacare Limited, South Africa 492 12.5mg Levofloxacin POM Solution for 179/071 Aspen Pharmacare Limited, South Africa Lanprox Solution For Infusion Hemihydrate 250mg, per infusion 493 50ml Clopidogrel Bisulfate POM Tablet Film coated 179/072 Aspen Pharmacare Limited, South Africa Bidogrel 75mg Tablets 494 75mg Ramipril 5mg + POM Tablet Uncoated 179/073 Aspen Pharmacare Limited, South Africa Co-Rampil Tablets Hydrochlorothiazide 495 25mg

Page 24 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Stavudine 150mg + POM Tablet Uncoated 222/007MT Aspen Pharmacare Limited, South Africa Stavudine 30mg + Lamivudine + Nevirapine Lamivudine/Nevirapine Tablets 496 300mg 497 Quinas Tablets Quinine 300mg POM Tablet Film coated 290/004 Astra Lifecare Pvt Limited Trimethoprim 80mg + POM Tablet Uncoated 290/010 Astra Lifecare Pvt Limited Astrim Tablets Sulfamethoxazole 400mg 498 Ampicillin 250mg + POM Capsule oral 290/012 Astra Lifecare Pvt Limited Aspiclox Capsules 499 Cloxacillin 250mg Amoxicilin Trihydrate POM Capsule oral 290/013 Astra Lifecare Pvt Limited Asmox Capsules 500 250mg 501 Asfulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 290/014 Astra Lifecare Pvt Limited Nicotinamide15mg + P Tablet 290/015 Astra Lifecare Pvt Limited Riboflavin 1mg + As-B Tablets Thiamine Mononitrate 502 1mg 503 Femin-P Pessaries Nystatin 100,000 IU P Tablet Vaginal 290/016 Astra Lifecare Pvt Limited Artemether 120mg + POM Tablet Uncoated 290/001 Astra Lifecare Pvt Limited, India Lumether Tablets 504 Lumefantrine 20mg 505 Ascodyl Tablets Bisacodyl 5mg P Tablet Film coated 290/002 Astra Lifecare Pvt Limited, India Hyocine butylbromide POM Tablet Film coated 290/003 Astra Lifecare Pvt Limited, India Ascopan Tablets 506 10mg 507 Asmol Tablets Paracetamol 500mg P Tablet Uncoated 290/005 Astra Lifecare Pvt Limited, India 508 Asdoxin Capsules Doxycycline 100mg POM Capsule oral 290/006 Astra Lifecare Pvt Limited, India 509 Asid Capsules Omeprazole 20mg POM Capsule oral 290/007 Astra Lifecare Pvt Limited, India 510 Gynest Pessaries Clotrimazole 100mg POM Tablet Vaginal 290/008 Astra Lifecare Pvt Limited, India Paracetamol 650mg + P Tablet Uncoated 290/009 Astra Lifecare Pvt Limited, India Painol - P Tablets 511 Caffeine 50mg 512 Asfen -FC Tablets Ibuprofen 200mg P Tablet Uncoated 290/011 Astra Lifecare Pvt Limited, India 513 Inderal 10mg Tablets Propranolol 10mg POM Tablet Uncoated 023/009 Astra Zeneca UK Limited 514 Inderal 40mg Tablets Propranolol 40mg POM Tablet Uncoated 023/010 Astra Zeneca UK Limited 515 Nolvadex 10mg Tablets Tamoxifen 10mg POM Tablet Uncoated 023/013 Astra Zeneca UK Limited 516 Paludrine 100mg Tablets Proguanil 100mg POM Tablet Uncoated 023/014 Astra Zeneca UK Limited 517 Tenormin 50mg Tablets Atenolol 50mg POM Tablet Uncoated 023/021 Astra Zeneca UK Limited 518 Tenormin 100mg Tablets Atenolol 100mg POM Tablet Uncoated 023/022 Astra Zeneca UK Limited Atenolol 100mg + POM Tablet Uncoated 023/023 Astra Zeneca UK Limited Tenoretic 100/25mg Tablets 519 Chlorthalidone 25mg Atenolol 50mg + POM Tablet Uncoated 023/024 Astra Zeneca UK Limited Tenoret 50/12.4mg Tablets 520 Chlorthalidone 12.4mg

Page 25 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 521 Zestril 5mg Tablets Lisinopril 5mg POM Tablet Uncoated 023/026 Astra Zeneca UK Limited 522 Zestril 10mg Tablets Lisinopril 10mg POM Tablet Uncoated 023/027 Astra Zeneca UK Limited 523 Zestril 20mg Tablets Lisinopril 20mg POM Tablet Uncoated 023/028 Astra Zeneca UK Limited 524 Nolvadex 10mg Tablets Tamoxifen 10mg POM Tablet Uncoated 023/031 Astra Zeneca UK Limited Formoterol 4.5mg POM Powder for 023/039 Astra Zeneca UK Limited Oxis Turbuhaler 525 Inhalation Formoterol 9mg POM Powder for 023/040 Astra Zeneca UK Limited Oxis 9mg Turbuhaler 526 Inhalation Budesonide 100mg POM Powder for 023/041 Astra Zeneca UK Limited Pulmcort 100 Turbuhaler 527 Inhalation Budesonide 200mg POM Powder for 023/042 Astra Zeneca UK Limited Pulmcort 200 Turbuhaler 528 Inhalation Budesonide 400mg POM Powder for 023/043 Astra Zeneca UK Limited Pulmcort 400 Turbuhaler 529 Inhalation 530 Losec Mumps 20 Tablets Omeprazole 20mg POM Tablet Film coated 023/044 Astra Zeneca UK Limited Hydrochlorothiazide POM Tablet Uncoated 023/045 Astra Zeneca UK Limited Zestrorectic Tablets 12.5mg + Lisinopril 20mg 531 Goserelin acetate implant POM Implant, Injection 023/046 Astra Zeneca UK Limited Zoladex 3.6mg Injection 532 3.6mg Formoterol 4.5mcg + POM Powder for 023/047 Astra Zeneca UK Limited Symbicort Turbuhaler 533 Budesonide 80mcg Inhalation 534 Arimidex 10mg Tablets Anastrozole 10mg POM Tablet Uncoated 023/051 Astra Zeneca UK Limited 535 Nexium 20 Tablets Esomeprazole 20mg POM Tablet Film coated 023/052 Astra Zeneca UK Limited 536 Nexium 40 Tablets Esomeprazole 40mg POM Tablet Film coated 023/053 Astra Zeneca UK Limited 537 Zmox Capsules Amoxicillin 250mg POM Capsule oral 127/001 Aurobindo Pharma Limited, India 538 Recipro 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 127/002 Aurobindo Pharma Limited, India 539 Recipro 250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 127/003 Aurobindo Pharma Limited, India Ampicillin 250mg POM Powder for 127/004 Aurobindo Pharma Limited, India Zcil 250 Injection 540 Injection 541 Renor 400 Tablets Norfloxacin 400mg POM Tablet Uncoated 127/005 Aurobindo Pharma Limited, India 542 Aurocef Capsules Cephalexin 250mg POM Capsule oral 127/006 Aurobindo Pharma Limited, India Cloxacillin 250mg + POM Capsule oral 127/007 Aurobindo Pharma Limited, India Zuclox Capsules 543 Ampicillin 250mg 544 Cloxil Capsules Cloxacillin 250mg POM Capsule oral 127/008 Aurobindo Pharma Limited, India 545 Zolcer Capsules Omeprazole 200mg POM Capsule oral 127/009 Aurobindo Pharma Limited, India 546 Lamivox 150 Tablets Lamivudine 150mg POM Tablet Uncoated 127/010 Aurobindo Pharma Limited, India 547 Stavex 40 Capsules Stavudine 40mg POM Capsule oral 127/011 Aurobindo Pharma Limited, India 548 Nevirex 200 Tablets Nevirapine 200mg POM Tablet Uncoated 127/012 Aurobindo Pharma Limited, India

Page 26 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 549 Indivex 400 Tablets Indinavir 400mg POM Tablet Uncoated 127/013 Aurobindo Pharma Limited, India 550 Didavex 100 Chewable Tablets Didanosine 100mg POM Tablet Chewable 127/014 Aurobindo Pharma Limited, India Lamivudine 150mg + POM Tablet Uncoated 127/015 Aurobindo Pharma Limited, India Zidovex - L Tablets 551 Zidovudine 300mg Lamivudine 150mg + POM Tablet Uncoated 127/016 Aurobindo Pharma Limited, India Stavex 30 L Tablets 552 Stavudine 30mg Lamivudine 150mg + POM Tablet Uncoated 127/017 Aurobindo Pharma Limited, India Stavex 40 L Tablets 553 Stavudine 40mg 554 Nelvex 250 Tablets Nelfinavir 250mg POM Tablet Uncoated 127/018 Aurobindo Pharma Limited, India Cephalexin 250mg, per POM Suspension for 127/019 Aurobindo Pharma Limited, India Aurocef 250 Oral Suspension 555 5ml Oral Use Cephalexin 125mg, per POM Suspension for 127/020 Aurobindo Pharma Limited, India Aurocef 125 Oral Suspension 556 5ml Oral Use Cefotaxime 1000mg POM Powder for 127/021 Aurobindo Pharma Limited, India Cetax 1000 Injection 557 Injection Erythromycin 125mg, per POM Suspension for 127/022 Aurobindo Pharma Limited, India Erythromycin Suspension 558 5ml Oral Use Chloramphenicol 1000mg POM Powder for 127/023 Aurobindo Pharma Limited, India Chloramphenicol Injection 559 Injection Ceftriaxone 1000mg POM Powder for 127/024 Aurobindo Pharma Limited, India Triaxone 1000 Injection 560 Injection Cloxacillin 500mg POM Powder for 127/025 Aurobindo Pharma Limited, India Cloxil 500 Injection 561 Injection Lamivudine + Zidovudine Lamivudine 150mg + POM Tablet Uncoated 127/026 Aurobindo Pharma Limited, India 562 Tablets Zidovudine 300mg 563 Nevirapine Tablets Nevirapine 200mg POM Tablet Uncoated 127/027 Aurobindo Pharma Limited, India 564 Stavudine 30 Capsules Stavudine 30mg POM Capsule oral 127/028 Aurobindo Pharma Limited, India 565 Stavudine 40 Capsules Stavudine 40mg POM Capsule oral 127/029 Aurobindo Pharma Limited, India 566 Efavirenz 600 Tablets Efavirenz 600mg POM Tablet Uncoated 127/030 Aurobindo Pharma Limited, India 567 Lamivudine 150mg Tablets Lamivudine 150mg POM Tablet Uncoated 127/031 Aurobindo Pharma Limited, India 568 Lamivudine 300mg Tablets Lamivudine 300mg POM Tablet Uncoated 127/032 Aurobindo Pharma Limited, India Zidovudine 50mg, per POM Solution for Oral 127/033 Aurobindo Pharma Limited, India Zidovudine Oral Solution 569 5ml Use Lamivudine 10mg, per ml POM Solution for Oral 127/034 Aurobindo Pharma Limited, India Lamivudine Oral Solution 570 Use Nevirapine 50mg, per POM Solution for Oral 127/035 Aurobindo Pharma Limited, India Nevirapine Oral Solution 571 5ml Use 572 Zidovudine Tablets Zidovudine 200mg POM Tablet Uncoated 127/036 Aurobindo Pharma Limited, India

Page 27 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Stavudine + Lamivudine Stavudine 30mg + POM Tablet Uncoated 127/037 Aurobindo Pharma Limited, India 573 30/150mg Tablets Lamivudine150mg Stavudine 40mg + POM Tablet Uncoated 127/038 Aurobindo Pharma Limited, India Stavudine + Lamivudine Tablets 574 Lamivudine 150mg 575 Abacavir Tablets Abacavir 300mg POM Tablet Uncoated 127/039 Aurobindo Pharma Limited, India Stavudine 1mg, per ml POM Solution for Oral 127/040 Aurobindo Pharma Limited, India Stavudine Oral Solution 576 Use Abacavir 20mg, per ml POM Solution for Oral 127/041 Aurobindo Pharma Limited, India Abacavir Sulphate Oral Solution 577 Use 578 Stavudine 20mg Capsules Stavudine 20mg POM Capsule oral 127/042 Aurobindo Pharma Limited, India 579 Stavudine 15mg Capsules Stavudine 15mg POM Capsule oral 127/043 Aurobindo Pharma Limited, India 580 Efavirenz 100mg Capsules Efavirenz 100mg POM Capsule oral 127/044 Aurobindo Pharma Limited, India Lamivudine 150mg + POM Tablet Uncoated 127/045 Aurobindo Pharma Limited, India Lamivudine + Zidovudine + Zidovudine 300mg + Nevirapine Tablets 581 Nevirapine 200mg Lamivudine 150mg + POM Tablet Uncoated 127/046 Aurobindo Pharma Limited, India Lamivudine + Zidovudine + Zidovudine 300mg + Efavirenz Tablets 582 Efavirenz 600mg 583 Efavirenz 200mg Capsules Efavirenz 200mg POM Capsule oral 127/047 Aurobindo Pharma Limited, India 584 Kardam 10 Tablets Amlodipine 10mg POM Tablet Uncoated 127/049 Aurobindo Pharma Limited, India 585 Kardam 5 Tablets Amlodipine 5mg POM Tablet Uncoated 127/050 Aurobindo Pharma Limited, India Amoxicillin 125mg + POM Suspension for 127/051 Aurobindo Pharma Limited, India Koact Oral Suspension Clavulanic acid 31.25mg Oral Use 586 , per 5ml Amoxicillin 250mg + POM Suspension for 127/052 Aurobindo Pharma Limited, India Koact Oral Suspension Clauvulanic acid 62.5mg, Oral Use 587 per 5ml Cefuroxime 750mg POM Powder for 127/053 Aurobindo Pharma Limited, India Cefurxime 750 Injection 588 Injection Cefuroxime 1500mg POM Powder for 127/054 Aurobindo Pharma Limited, India Cefurxime 1500 Injection 589 Injection 590 Didanosine Chewable Tablets Didanosine 100mg POM Tablet Chewable 127/055 Aurobindo Pharma Limited, India 591 Didanosine Chewable Tablets Didanosine 150mg POM Tablet Chewable 127/056 Aurobindo Pharma Limited, India 592 Didanosine Chewable Tablets Didanosine 200mg POM Tablet Chewable 127/057 Aurobindo Pharma Limited, India Ampicillin 500mg POM Powder for 127/059 Aurobindo Pharma Limited, India Zcil 500mg Injection 593 Injection 594 Aurocef 500mg Capsules Cephalexin 500mg POM Capsule oral 127/060 Aurobindo Pharma Limited, India Amoxicillin 125mg, per POM Suspension for 127/061 Aurobindo Pharma Limited, India Zmox Oral Suspension 595 5ml Oral Use

Page 28 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Ampicillin 125mg, per POM Suspension for 127/062 Aurobindo Pharma Limited, India Zcil Oral Suspension 596 5ml Oral Use Sulphamethoxazole POM Tablet Uncoated 127/063 Aurobindo Pharma Limited, India Combact 480mg Tablets 400mg +Trimethoprim 597 80mg Trimethoprim 40mg + POM Suspension for 127/064 Aurobindo Pharma Limited, India Combact Suspension Sulfamethoxazole 200mg Oral Use 598 599 Cefuxime 125 Tablets Cefuroxime 125mg POM Tablet Uncoated 127/065 Aurobindo Pharma Limited, India 600 Cefuxime 250 Tablets Cefuroxime 250mg POM Tablet Uncoated 127/066 Aurobindo Pharma Limited, India 601 Cefuxime 500 Tablets Cefuroxime 500mg POM Tablet Uncoated 127/067 Aurobindo Pharma Limited, India Amoxicillin 250mg + POM Tablet Uncoated 127/068 Aurobindo Pharma Limited, India Koact 375 Tablets 602 Clavulanic acid 125mg Amoxicillin 500mg + POM Tablet Uncoated 127/069 Aurobindo Pharma Limited, India Koact 625 Tablets 603 Clavulanic acid 125mg Amoxicillin 875mg + POM Tablet Uncoated 127/070 Aurobindo Pharma Limited, India Koact 1000 Tablets 604 Clavulanic acid 125mg Stavudine 30mg + POM Tablet Uncoated 127/071 Aurobindo Pharma Limited, India Stavudine + Lamivudine + Lamivudine 150mg + Nevirapine Tablets 605 Nevirapine 200mg Didanosine Delayed Released Didanosine 400mg POM Capsule oral 127/072 Aurobindo Pharma Limited, India 606 Capsules 607 Didanosine Capsules Didanosine 250mg POM Capsule oral 127/073 Aurobindo Pharma Limited, India Tenofivir Disoproxil POM Tablet Uncoated 127/074 Aurobindo Pharma Limited, India Emtricitabine + Tenofovir Fumerate 200mg + Tablets 608 Emtricitabine 300mg Lopinavir 200mg + POM Tablet Uncoated 127/075 Aurobindo Pharma Limited, India Lopinavir/Ritonavir Tablets 609 Ritonavir 50mg 610 Angiram 2.5 Tablets Ramipril 2.5mg POM Tablet Uncoated 127/076 Aurobindo Pharma Limited, India 611 Angiram 5 Tablets Ramipril 5mg POM Tablet Uncoated 127/077 Aurobindo Pharma Limited, India 612 Angiram 10 Tablets Ramipril 10mg POM Tablet Uncoated 127/078 Aurobindo Pharma Limited, India 613 Aroxicam 7.5 Tablets Meloxicam 7.5mg POM Tablet Uncoated 127/079 Aurobindo Pharma Limited, India 614 Aroxicam 15 Tablets Meloxicam 15mg POM Tablet Uncoated 127/080 Aurobindo Pharma Limited, India 615 Auro Metformin 500 Tablets Metformin 500mg POM Tablet Uncoated 127/081 Aurobindo Pharma Limited, India 616 Auro Metformin 850 Tablets Metformin 850mg POM Tablet Uncoated 127/082 Aurobindo Pharma Limited, India Tenofivir Disoproxil Fumarate Tenofovir 300mg POM Tablet Film coated 127/083 Aurobindo Pharma Limited, India 617 Tablets

Page 29 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Lamivudine 300mg + POM Tablet Film coated 127/084 Aurobindo Pharma Limited, India Lamivudine & Tenofovir Tenofovir Disoproxil Disoproxil Fumarate Tablets 618 Fumarate 300mg Efavirenz 600mg + POM Tablet Uncoated 127/085 Aurobindo Pharma Limited, India Efavirenz + Emtricitabine + Emtricitabine 200mg + Tenofovir Tablets 619 Tenofovir 300mg Efavirenz 600mg + POM Tablet Uncoated 127/086 Aurobindo Pharma Limited, India Efavirenz + Lamivudine + Emtricitabine 300mg + Tenofovir Tablets 620 Tenofovir 300mg Dolutegravir 50mg + Lamivudine Dolutegravir 50mg + POM Tablet Film coated 127/087 Aurobindo Pharma Limited, India 300mg + Tenofovir Disoproxil Lamivudine 300mg + Fumarate 300mg Tenofovir Disoproxil 621 Fumarate 300mg 622 Tissop Capsules Indomethacin 25mg P Capsule oral 178/001 Aurochem Laboratories Pvt, Limited, India 623 Feverlet Tablets Paracetamol 500mg GS Tablet Uncoated 178/002 Aurochem Laboratories Pvt, Limited, India Antacid 550mg GS Suspension for 178/003 Aurochem Laboratories Pvt, Limited, India Nutrigel Suspension 624 Oral Use 625 Perfopil 50 Tablets Sildenafil 50mg POM Tablet Uncoated 178/004 Aurochem Laboratories Pvt, Limited, India 626 Cerocip 250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 178/005 Aurochem Laboratories Pvt, Limited, India 627 Cerocip 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 178/006 Aurochem Laboratories Pvt, Limited, India 628 Rumifen 200 Tablets Ibuprofen 200mg P Tablet Uncoated 178/007 Aurochem Laboratories Pvt, Limited, India Sulfadoxine 500mg + P Tablet Uncoated 178/008 Aurochem Laboratories Pvt, Limited, India Melamine Tablets 629 Pyrimethamine 25mg 630 Defnil-SR Tablets Diclofenac 100mg P Tablet Uncoated 178/009 Aurochem Laboratories Pvt, Limited, India Pyrantel Pamoate P Suspension for 178/010 Aurochem Laboratories Pvt, Limited, India Telmentic Suspension 631 250mg, per 5ml Oral Use Pyrantel Pamoate 125mg P Tablet Uncoated 178/011 Aurochem Laboratories Pvt, Limited, India Telmentic Tablets 632 633 Mucof Cough Lozenges Herbal Extracts P Lozenges 178/012 Aurochem Laboratories Pvt, Limited, India 634 Repisprin-300 Tablets Aspirin 300mg P Tablet Uncoated 178/013 Aurochem Laboratories Pvt, Limited, India Cloxacillin 125mg, per POM Solution for Oral 178/014 Aurochem Laboratories Pvt, Limited, India Betaclox Solution 635 5ml Use Paracetamol 120mg + P Syrup 178/015 Aurochem Laboratories Pvt, Limited, India Chlorpheniramine 0.5mg Dr Home Cough Syrup + Phenylephrine 2.5mg, 636 per 5ml Erythromycin 125mg, per POM Suspension for 178/016 Aurochem Laboratories Pvt, Limited, India Lymphocin Suspension 637 5ml Oral Use

Page 30 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Chlorpheniramine 2.2mg P Syrup 178/017 Aurochem Laboratories Pvt, Limited, India + Ammonium Chloride Alcof Syrup 110mg + Sodium citrate 50mg + Menthol 1.1mg, 638 per 5ml 639 Chlorpheniramine 4 Tablets Chlorpheniramine 4mg P Tablet Uncoated 178/018 Aurochem Laboratories Pvt, Limited, India 640 Chlorpheniramine 2 Tablets Chlorpheniramine 2mg P Tablet Uncoated 178/019 Aurochem Laboratories Pvt, Limited, India 641 Welvit Syrup Multivitamins GS Syrup 178/023 Aurochem Laboratories Pvt, Limited, India Metronidazole 125mg, POM Solution for Oral 178/024 Aurochem Laboratories Pvt, Limited, India Zobinace Solution 642 per 5ml Use 643 Neuroflex Tablets Vitamin B Complex P Tablet Uncoated 178/025 Aurochem Laboratories Pvt, Limited, India 644 Rocort-H Cream Hydrocortisone 2%w/w POM Cream Topical 178/026 Aurochem Laboratories Pvt, Limited, India 645 Adnicor Tablets Prednisolone 5mg POM Tablet Uncoated 178/027 Aurochem Laboratories Pvt, Limited, India 646 Bisix Tablets Pyridoxine 50mg POM Tablet Uncoated 178/028 Aurochem Laboratories Pvt, Limited, India 647 Aurovir Cream Acyclovir 5%w/w POM Cream Topical 178/029 Aurochem Laboratories Pvt, Limited, India Sodium chloride 0.9% POM Solution for 015/001 Autosterile (EA) Limited, Kenya Normal Saline Solution 648 w/v infusion Autosterile 10% Glucose Dextrose 10% w/v POM Solution for 015/002 Autosterile (EA) Limited, Kenya 649 Injection infusion Dextrose 5% w/v + POM Solution for 015/003 Autosterile (EA) Limited, Kenya Autosterile 5% Glucose + 0.9% Sodium Chloride 0.9% infusion Sodium Chloride Injection 650 w/v Sodium Chloride + POM Solution for 015/004 Autosterile (EA) Limited, Kenya Autosterile Half Strength Sodium lactate + infusion Darrows Injection 651 Potassium Chloride Dextrose 5% w/v POM Solution for 015/005 Autosterile (EA) Limited, Kenya Glucose 5% Injection 652 Injection Sodium Chloride + POM Solution for 015/006 Autosterile (EA) Limited, Kenya Sodium Lactate + infusion Ringers Lactate Injection Potassium Chloride + 653 Calcium Chloride Sodium Chloride + POM Solution for 096/001 Autosterile Pvt Limited, Zimbabwe Sodium Lactate + infusion Ringers Lactate Infusion Calcium Chloride + 654 Potassium Chloride Glucose 5% w/v POM Solution for 096/002 Autosterile Pvt Limited, Zimbabwe Glucose Infusion 655 infusion Sodium chloride 0.9% POM Solution for 096/003 Autosterile Pvt Limited, Zimbabwe Sodium Chloride Infusion 656 w/v infusion

Page 31 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Yellow Fever virus strain POM Suspension for 049/001 Aventis Pasteur SA Pty Limited Stamaril Vaccine 17D/AB 237- Live Injection 657 attenuated Meningococcal A + C POM Solution for 049/002 Aventis Pasteur SA Pty Limited Imovax Meningo A + C Vaccine 658 Polysaccharide vaccine Injection Measles + Mumps + POM Suspension for 049/003 Aventis Pasteur SA Pty Limited Trimovax Vaccine 659 Rubella - Live attenuated Injection Purified VI capsular POM Suspension for 049/004 Aventis Pasteur SA Pty Limited Typhim VI Vaccine polysaccaride of Injection 660 Salmonella typhi type 2 Tetanus toxoid- Purified POM Suspension for 049/005 Aventis Pasteur SA Pty Limited Tetavax Vaccine 661 Injection 662 Diabend Tablets Gliclazide 80mg POM Tablet Uncoated 288/001 Bal Pharma Limited, India 663 Grisoral 250mg Tablets Griseofulvin 250mg POM Tablet oral 288/002 Bal Pharma Limited, India 664 Regamol 500mg Tablets Paracetamol 500mg GS Tablet oral 288/003 Bal Pharma Limited, India 665 Dynamox - 250 Capsules Amoxicillin 250mg POM Capsule oral 288/004 Bal Pharma Limited, India 666 Dynamox - 500 Capsules Amoxicillin 500mg POM Capsule oral 288/005 Bal Pharma Limited, India 667 Ibuprofen Tablets Ibuprofen 400mg P Tablet Film coated 288/006 Bal Pharma Limited, India 668 Seregra-50 Tablets Sildenafil 50mg POM Tablet Uncoated 288/007 Bal Pharma Limited, India 669 Seregra-100 Tablets Sildenafil 100mg POM Tablet Uncoated 288/008 Bal Pharma Limited, India Diclofenac 50mg P Tablet Enteric 288/009 Bal Pharma Limited, India Diclofenac Sodium Tablets 670 Coated Miconazole 2% w/w POM Gel Oral 009/014 Baxy Pharmaceutical Manufacturing Ltd, Mycoral Oral Gel 671 Zambia Hyoscine butyl bromide POM Tablet Uncoated 009/047 Baxy Pharmaceutical Manufacturing Ltd, Hyoscine Butyl Bromide Tablets 672 20mg Zambia Cephalexin 125mg/5mls POM Suspension for 009/074 Baxy Pharmaceutical Manufacturing Ltd, Cephalexin Suspension 673 Oral Use Zambia Cephalexin 250mg POM Capsule oral 009/075 Baxy Pharmaceutical Manufacturing Ltd, Cephalexin 250mg Capsules 674 Zambia Cephalexin 500mg POM Capsule oral 009/076 Baxy Pharmaceutical Manufacturing Ltd, Cephalexin 500mg Capsules 675 Zambia Ampicillin 250mg POM Capsule oral 009/077 Baxy Pharmaceutical Manufacturing Ltd, Ampicillin 250mg Capsules 676 Zambia Ampicillin 500mg POM Capsule oral 009/078 Baxy Pharmaceutical Manufacturing Ltd, Ampicillin 500mg Capsules 677 Zambia Rifampicin 150mg POM Capsule oral 009/079 Baxy Pharmaceutical Manufacturing Ltd, Rifampicin Capsules 678 Zambia

Page 32 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Rifampicin 300mg POM Capsule oral 009/080 Baxy Pharmaceutical Manufacturing Ltd, Rifampicin Capsules 679 Zambia Amoxycillin 250mg POM Capsule oral 009/081 Baxy Pharmaceutical Manufacturing Ltd, Amoxycillin Capsules 680 Zambia Amoxycillin 500mg POM Capsule oral 009/082 Baxy Pharmaceutical Manufacturing Ltd, Amoxycillin 250mg Capsules 681 Zambia Doxycycline 100mg POM Capsule oral 009/083 Baxy Pharmaceutical Manufacturing Ltd, Doxycycline Capsules 682 Zambia Piroxicam 10mg POM Capsule oral 009/084 Baxy Pharmaceutical Manufacturing Ltd, Piroxicam Capsules 683 Zambia Cloxacillin 250mg + POM Suspension for 009/085 Baxy Pharmaceutical Manufacturing Ltd, Cloxamp Granules 684 Ampicillin 250mg Oral Use Zambia Mefenamic acid 250mg POM Capsule oral 009/086 Baxy Pharmaceutical Manufacturing Ltd, Mefenamic Acid Capsules 685 Zambia Tetracycline 250mg POM Capsule oral 009/087 Baxy Pharmaceutical Manufacturing Ltd, Tetracycline Capsules 686 Zambia Paracetamol 500mg GS Tablet Uncoated 009/089 Baxy Pharmaceutical Manufacturing Ltd, Paracetamol 500mg Tablets 687 Zambia Glibenclamide 5mg POM Tablet Uncoated 009/090 Baxy Pharmaceutical Manufacturing Ltd, Glibenclamide Tablets 688 Zambia Pyrazinamide 500mg POM Tablet Uncoated 009/091 Baxy Pharmaceutical Manufacturing Ltd, Pyrazinamide Tablets 689 Zambia Sulphadoxine 500mg + P Tablet Uncoated 009/092 Baxy Pharmaceutical Manufacturing Ltd, Gamsidar Tablets 690 Pyrimethamine 25mg Zambia Paracetamol 100mg GS Tablet Uncoated 009/093 Baxy Pharmaceutical Manufacturing Ltd, Paracetamol 100mg Tablets 691 Zambia Allopurinol 300mg POM Tablet Uncoated 009/094 Baxy Pharmaceutical Manufacturing Ltd, Alluopurinol Tablets 692 Zambia Metronidazole 200mg POM Tablet Uncoated 009/095 Baxy Pharmaceutical Manufacturing Ltd, Metronidazole Tablets 693 Zambia Ethambutol 400mg POM Tablet Uncoated 009/097 Baxy Pharmaceutical Manufacturing Ltd, Ethambutol Tablets 694 Zambia Amiloride 5mg + POM Tablet Uncoated 009/098 Baxy Pharmaceutical Manufacturing Ltd, Gamuretic Tablets Hydrochlorothiazide Zambia 695 50mg Griseofulvin 500mg POM Tablet Uncoated 009/099 Baxy Pharmaceutical Manufacturing Ltd, Griseofulvin Tablets 696 Zambia Promethazine 25mg, per POM Solution for 009/100 Baxy Pharmaceutical Manufacturing Ltd, Promethazine Injection 697 ml Injection Zambia

Page 33 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Streptomycin 1g POM Powder for 009/101 Baxy Pharmaceutical Manufacturing Ltd, Streptomycin Injection 698 Injection Zambia Cloxacillin 250mg POM Powder for 009/102 Baxy Pharmaceutical Manufacturing Ltd, Cloxacillin Injection 699 Injection Zambia Atropine 0.6mg, per ml POM Solution for 009/103 Baxy Pharmaceutical Manufacturing Ltd, Atropine Injection 700 Injection Zambia Gentamycin 10mg, per ml POM Solution for 009/104 Baxy Pharmaceutical Manufacturing Ltd, Gentamycin Injection 701 Injection Zambia Gentamycin 40mg, per ml POM Solution for 009/105 Baxy Pharmaceutical Manufacturing Ltd, Gentamycin Injection 702 Injection Zambia Kanamycin 1g POM Powder for 009/107 Baxy Pharmaceutical Manufacturing Ltd, Kanamycin Injection 703 Injection Zambia Allopurinol 100mg POM Tablet Uncoated 009/109 Baxy Pharmaceutical Manufacturing Ltd, Allopurinol Tablets 704 Zambia Ketamine 50mg, per ml POM Solution for 009/110 Baxy Pharmaceutical Manufacturing Ltd, Ketamine Injection 705 Injection Zambia Frusemide 10mg, per ml POM Solution for 009/111 Baxy Pharmaceutical Manufacturing Ltd, Frusemide Injection 706 Injection Zambia Metoclopramide 5mg, per POM Solution for 009/112 Baxy Pharmaceutical Manufacturing Ltd, Metoclopramide Injection 707 ml Injection Zambia Chlorpromazine 25mg, POM Solution for 009/113 Baxy Pharmaceutical Manufacturing Ltd, Chlorpromazine Injection 708 per ml Injection Zambia Praziquantel 600mg POM Tablet Uncoated 009/114 Baxy Pharmaceutical Manufacturing Ltd, Praziquantel Tablets 709 Zambia Metronidazole 0.5% w/v POM Solution for 009/115 Baxy Pharmaceutical Manufacturing Ltd, Metronidazole Injection 710 Injection Zambia Isoniazid 100mg POM Tablet Uncoated 009/117 Baxy Pharmaceutical Manufacturing Ltd, Isoniazid Tablets 711 Zambia Ibuprofen 400mg P Tablet Uncoated 009/118 Baxy Pharmaceutical Manufacturing Ltd, Ibuprofen Tablets 712 Zambia Pethidine 50mg, per ml POM Solution for 009/119 Baxy Pharmaceutical Manufacturing Ltd, Pethidine 50mg/ml Injection 713 Injection Zambia Propranolol 40mg POM Tablet Uncoated 009/120 Baxy Pharmaceutical Manufacturing Ltd, Propranolol Tablets 714 Zambia Phenobarbitone 30mg POM Tablet Uncoated 009/123 Baxy Pharmaceutical Manufacturing Ltd, Phenobarbitone Tablets 715 Zambia Phenobarbitone 60mg POM Tablet Uncoated 009/124 Baxy Pharmaceutical Manufacturing Ltd, Phenobarbitone Tablets 716 Zambia

Page 34 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Pethidine 25mg, per ml POM Solution for 009/125 Baxy Pharmaceutical Manufacturing Ltd, Pethidine 25mg/Ml Injection 717 Injection Zambia Cloxacillin + Ampicillin POM Powder for 009/126 Baxy Pharmaceutical Manufacturing Ltd, Cloxamp Injection 718 500mg Injection Zambia Cefotaxime 500mg POM Powder for 009/128 Baxy Pharmaceutical Manufacturing Ltd, Cefotaxime Injection 719 Injection Zambia Ampicillin 250mg POM Powder for 009/130 Baxy Pharmaceutical Manufacturing Ltd, Ampicilllin Injection 720 Injection Zambia Glucose 50% w/v POM Solution for 009/131 Baxy Pharmaceutical Manufacturing Ltd, Glucose Injection 721 infusion Zambia Ciprofloxacin 250mg POM Tablet Uncoated 009/134 Baxy Pharmaceutical Manufacturing Ltd, Ciprofloxacin Tablets 722 Zambia Diazepam 5mg, per ml POM Solution for 009/135 Baxy Pharmaceutical Manufacturing Ltd, Diazepam Injection 723 Injection Zambia Hyoscine Butyl Bromide Hyoscine butyl bromide POM Solution for 009/136 Baxy Pharmaceutical Manufacturing Ltd, 724 Injection 20mg, per ml Injection Zambia Norethisterone 5 mg POM Tablet Uncoated 009/137 Baxy Pharmaceutical Manufacturing Ltd, Norethisterone Tablets 725 Zambia Proguanil 100mg POM Tablet Uncoated 009/138 Baxy Pharmaceutical Manufacturing Ltd, Proguanil Tablets 726 Zambia Propantheline 15mg POM Tablet Uncoated 009/139 Baxy Pharmaceutical Manufacturing Ltd, Propantheline Tablets 727 Zambia Quinine Dihydrochloride Quinine 300mg, per ml POM Solution for 009/140 Baxy Pharmaceutical Manufacturing Ltd, 728 Injection Injection Zambia Quinine 300mg POM Tablet Uncoated 009/141 Baxy Pharmaceutical Manufacturing Ltd, Quinine Suphate Tablets 729 Zambia Mebendazole 100mg, per P Suspension for 009/142 Baxy Pharmaceutical Manufacturing Ltd, Wormcid Suspension 730 5ml Oral Use Zambia Metformin 500mg POM Tablet Uncoated 009/143 Baxy Pharmaceutical Manufacturing Ltd, Metformin Tablets 731 Zambia Ketoconazole 100mg POM Gel Oral 009/145 Baxy Pharmaceutical Manufacturing Ltd, Ketazole Gel 732 Zambia Diphenhydramine P Syrup 009/146 Baxy Pharmaceutical Manufacturing Ltd, Hydrochloride 14mg + Zambia Ammonium Chloride Gamma Cough Syrup 135mg + Sodium Citrate 52mg Menthol 1.1mg, per 733 5mls

Page 35 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Phytomenadione 10mg, per ml Phytomenadione 10mg, POM Solution for 009/148 Baxy Pharmaceutical Manufacturing Ltd, 734 Injection per ml Injection Zambia Ketoconazole 200mg POM Tablet Uncoated 009/149 Baxy Pharmaceutical Manufacturing Ltd, Ketoconazole Tablets 735 Zambia Benzhexol 2mg POM Tablet Uncoated 009/150 Baxy Pharmaceutical Manufacturing Ltd, Benzhexol Tablets 736 Zambia Promethazine 10mg, per POM Solution for 009/151 Baxy Pharmaceutical Manufacturing Ltd, Promethazine Injection 737 ml Injection Zambia Dexmethasone 4mg, per POM Solution for 009/152 Baxy Pharmaceutical Manufacturing Ltd, Dexmethasone Injection 738 ml Injection Zambia Phytomenadione 2mg, per ml Phytomenadione 2mg, POM Solution for 009/153 Baxy Pharmaceutical Manufacturing Ltd, 739 injection per ml Injection Zambia Enalapril 5mg POM Tablet Uncoated 009/154 Baxy Pharmaceutical Manufacturing Ltd, Enalapril Tablets 740 Zambia Benzhexol 5mg POM Tablet Uncoated 009/155 Baxy Pharmaceutical Manufacturing Ltd, Benzhexol Tablets 741 Zambia Nifedipine 10mg POM Tablet Uncoated 009/156 Baxy Pharmaceutical Manufacturing Ltd, Nifedipine Tablets 742 Zambia Bendroflumethiazide 5mg POM Tablet Uncoated 009/157 Baxy Pharmaceutical Manufacturing Ltd, Bendroflumethiazide Tablets 743 Zambia Theophylline 120mg + POM Tablet Uncoated 009/158 Baxy Pharmaceutical Manufacturing Ltd, Theophylline Compound Tablets Ephedrine hydrochloride Zambia 744 11mg Acyclovir 200mg POM Tablet Uncoated 009/159 Baxy Pharmaceutical Manufacturing Ltd, Acyclovir Tablets 745 Zambia Timolol 0.25% w/v POM Eye Drops 009/160 Baxy Pharmaceutical Manufacturing Ltd, Timolol Eye Drops 746 Zambia Gentamycin 0.3% w/v POM Eye Drops 009/161 Baxy Pharmaceutical Manufacturing Ltd, Gentamycin Eye Drops 747 Zambia Acetazolamide 250mg POM Tablet Uncoated 009/162 Baxy Pharmaceutical Manufacturing Ltd, Acetazolamide Tablets 748 Zambia Chloramphenicol 125mg, POM Suspension for 009/163 Baxy Pharmaceutical Manufacturing Ltd, Chloramphenicol Suspension 749 per 5ml Oral Use Zambia Bisacodyl 5mg POM Tablet Uncoated 009/165 Baxy Pharmaceutical Manufacturing Ltd, Biscodyl Tablets 750 Zambia Metoclopramide 10mg POM Tablet Uncoated 009/166 Baxy Pharmaceutical Manufacturing Ltd, Metoclopramide Tablets 751 Zambia Nystatin 500,000 I.U. POM Tablet Uncoated 009/167 Baxy Pharmaceutical Manufacturing Ltd, Nystatin Tablets 752 Zambia

Page 36 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Nitrofurantoin 100mg POM Tablet Uncoated 009/168 Baxy Pharmaceutical Manufacturing Ltd, Nitrofurantoin Tablets 753 Zambia Loperamide 2mg POM Tablet Uncoated 009/169 Baxy Pharmaceutical Manufacturing Ltd, Loperamide Tablets 754 Zambia Mebendazole 100mg P Tablet Uncoated 009/170 Baxy Pharmaceutical Manufacturing Ltd, Mebendazole Tablets 755 Zambia Fluconazole 2mg, per ml POM Solution for 009/171 Baxy Pharmaceutical Manufacturing Ltd, Fluconazole 2mg Injection 756 Injection Zambia Cetylpyridinium Throat Cetylpyridinium 1.4mg P Tablet Uncoated 009/172 Baxy Pharmaceutical Manufacturing Ltd, 757 Lozenges Zambia Aminophylline 100mg POM Tablet Uncoated 009/173 Baxy Pharmaceutical Manufacturing Ltd, Aminophylline Tablets 758 Zambia Ascorbic acid 100mg GS Tablet Uncoated 009/174 Baxy Pharmaceutical Manufacturing Ltd, Ascobic Acid Tablets 759 Zambia Atenolol 100mg POM Tablet Uncoated 009/175 Baxy Pharmaceutical Manufacturing Ltd, Atenolol 100mg Tablets 760 Zambia Betamethasone 0.1% w/v POM Eye Drops 009/176 Baxy Pharmaceutical Manufacturing Ltd, Betasone Eye Drops 761 Zambia Diclofenac 50mg P Tablet Uncoated 009/177 Baxy Pharmaceutical Manufacturing Ltd, Diclofenac 50mg Tablets 762 Zambia Digoxin 0.25mg POM Tablet Uncoated 009/178 Baxy Pharmaceutical Manufacturing Ltd, Digoxin 0.25mg Tablets 763 Zambia Digoxin 0.25mg POM Solution for 009/179 Baxy Pharmaceutical Manufacturing Ltd, Digoxin 0.25mg Injection 764 Injection Zambia Duosept Hospital Concentration Chlorhexidine 1.5% w/v + GS Solution for 009/180 Baxy Pharmaceutical Manufacturing Ltd, 765 Solution Cetrimide 15% w/v sterilisation Zambia Sodium Cromoglycate POM Eye Drops 009/181 Baxy Pharmaceutical Manufacturing Ltd, Eyecrom Eye/Ear Drops 766 2% w/v Zambia Fentanyl 50mcg, per 2ml POM Solution for 009/182 Baxy Pharmaceutical Manufacturing Ltd, Fentanyl 50mcg/2ml Injection 767 Injection Zambia Clotrimazole 1% w/w POM Cream Topical 009/183 Baxy Pharmaceutical Manufacturing Ltd, Fungicid Cream 768 Zambia Hydrocortisone 1% w/w POM Cream Topical 009/184 Baxy Pharmaceutical Manufacturing Ltd, Gammcort Cream 769 Zambia Nalbuphine 10mg, per POM Solution for 009/185 Baxy Pharmaceutical Manufacturing Ltd, Nalbuphine Injection 770 2mls Injection Zambia Glutaraldehyde 2% w/v GS Solution for 009/186 Baxy Pharmaceutical Manufacturing Ltd, Sterdidex Solution 771 sterilisation Zambia

Page 37 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Chlorpheniramine 2mg + P Syrup 009/187 Baxy Pharmaceutical Manufacturing Ltd, Ammonium chloride Zambia Tac Cough Syrup 135mg + Sodium citrate 772 59.26mg Dioctly Sulphosuccinate P Ear Drops 009/188 Baxy Pharmaceutical Manufacturing Ltd, Waxpel Ear Drops 773 sodium 312mg Zambia Atenolol 50mg POM Tablet Uncoated 009/189 Baxy Pharmaceutical Manufacturing Ltd, Atenolol 50mg Tablets 774 Zambia Zinc sulphate 20mg P Tablet Dispersible 009/190 Baxy Pharmaceutical Manufacturing Ltd, B Zinc Dispersible Tablets 775 Zambia Diphenhydramine P Syrup 009/191 Baxy Pharmaceutical Manufacturing Ltd, Hydrochloride 6.25mg + Zambia Baxylin 4Flu Cough Syrup Paracetamol 250mg + Pseudoephedrine 11.5mg 776 Dextromethophan P Syrup 009/192 Baxy Pharmaceutical Manufacturing Ltd, Baxylin Dry Cough Syrup 777 Hydrobromide 15mg Zambia Diphenhydramine P Syrup 009/193 Baxy Pharmaceutical Manufacturing Ltd, Baxylin Pediatric Cough Syrup Hydrochloride 7mg, per Zambia 778 5ml Guaphenesin 100mg, per P Syrup 009/194 Baxy Pharmaceutical Manufacturing Ltd, Baxylin Wet Cough Syrup 779 5ml Zambia Diphenhydramine P Syrup 009/195 Baxy Pharmaceutical Manufacturing Ltd, Hydrochloride 12.5mg + Zambia Baxylin with Codeine Cough Codeine Phosphate Syrup 10mg + Ammonium 780 Chloride 125mg Iopromide 300mg, per ml POM Solution for 140/015 Bayer (Pty) Limited, South Africa Ultravist 300 Injection 781 infusion Gadovist® (1.0 mmol/ml) Gadobutrol 604 mg, per POM Solution for 140/017 Bayer (Pty) Limited, South Africa 782 Injection ml (1.0 mmol/, per ml) infusion Ethinylestradiol 0.03mg + POM Tablet Uncoated 140/004 Bayer East Africa Ltd Microgynon Tablets Levonorgestrel 0.15mg 783 784 Primolut – N Tablets Norethisterone 5mg POM Tablet Uncoated 140/005 Bayer East Africa Ltd Ethinyestradiol 0.035mg POM Tablet Uncoated 140/007 Bayer East Africa Ltd Diane – 35 Tablets 785 + Cyproterone 2mg Norethisterone 200mg, POM Solution for 140/008 Bayer East Africa Ltd Noristerat Injection 786 per ml injection

Page 38 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Isoconazole Nitrate POM Suppositories 140/009 Bayer East Africa Ltd Gyno Trovogen Ovules 787 600mg Vaginal Acetyl Salicylic Acid POM Tablet Enteric 227/005 Bayer East Africa Ltd Bayer Aspirin Cardio 1 tablets 788 100mg Coated 789 Claritine Syrup Loratidine 5mg, per 5ml POM Syrup 042/001 Bayer Health Care PRIMOVIST 10ml Infusion Sodium Gadoxetate POM Solution for 140/021L Bayer Schering Pharma 790 Solution 0.25mol/L infusion UROGRAFIN 60% Solution for Meglumine amidotrizoate POM Solution for 140/019L Bayer Schering Pharma Infusion 0.52 g/ml plus sodium infusion amidotrizoate 0.080g/ml 791 UROGRAFIN 30% Solution for meglumine amidotrizoate POM Solution for 140/018L Bayer Schering Pharma Infusion 0,26 g/ml and infusion sodiumamidotrizoate 0,04 g/ml 792 UROGRAFIN 76% Solution for Meglumine amidotrizoate POM Solution for 140/020L Bayer Schering Pharma Injection 0.26 g/ml plus sodium infusion amidotrizoate 0,040g/ml 793 Metronidazole 750mg + POM Ovule Vaginal 140/010 Bayer Schering Pharma, Germany Neo - Penotran Forte Ovules 794 Miconazole 200mg Ethinylestradiol 0.15mg + POM Tablet Film coated 140/011 Bayer Schering Pharma, Germany Levonogestrel 0.03mg + Combination 3 Tablets Ferrous Fumurate 75mg 795 Ethinylestradiol 0.02mg + POM Tablet Film coated 140/012 Bayer Schering Pharma, Germany Yaz Tablets 796 Drospirenone 3.00mg Levonogesterel 0.15mg + POM Tablet Film coated 140/013 Bayer Schering Pharma, Germany Ethinylestradiol 0.03mg + Microgynon ED Fe Tablets Ferrous Sulphate 75mg 797 798 Microlut Tablets Levonogestrel 0.03mg POM Tablet Film coated 140/014 Bayer Schering Pharma, Germany 799 Praziquantel Tablets Praziquantel 600mg POM Tablet Uncoated 199/001 BDH Industries Ltd, India Hydrocortisone Ophthalmic Hydrocortisone 1%w/v POM Eye Suspension 199/002 BDH Industries Ltd, India 800 Suspension Chloramphenicol POM Eye Drops 199/003 BDH Industries Ltd, India Chloramphenicol Eye Drops 801 0.5%w/v 802 Atenol Tablets Atenolol 50mg POM Tablet Uncoated 199/004 BDH Industries Ltd, India

Page 39 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 803 Atenol Tablets Atenolol 100mg POM Tablet Uncoated 199/005 BDH Industries Ltd, India 804 Folid Tablets Folic acid 5mg GS Tablet Uncoated 199/006 BDH Industries Ltd, India Sulfamethoxazole 400mg POM Tablet Uncoated 199/007 BDH Industries Ltd, India Fortrim-A Tablets + Trimethoprim 80mg 805 806 Hydrocortisone Acetate Cream Hydrocortisone 1%w/v POM Cream Topical 199/008 BDH Industries Ltd, India 807 Hydrocortisone Ointment Hydrocortisone 1% POM Ointment topical 199/009 BDH Industries Ltd, India 808 Indosule Capsules Indomethacin 25mg P Tablet Uncoated 199/010 BDH Industries Ltd, India 809 Metadil Tablets Chlorpheniramine 4mg P Tablet Uncoated 199/011 BDH Industries Ltd, India 810 Metamol Tablets Paracetamol 500mg GS Tablet Uncoated 199/012 BDH Industries Ltd, India 811 Metapred Tablets Prednisolone 5mg POM Tablet Uncoated 199/013 BDH Industries Ltd, India 812 Acyclovir Cream Acyclovir 5%w/w POM Tablet Uncoated 199/014 BDH Industries Ltd, India 813 Micozol Cream Miconazole 2% POM Cream Topical 199/015 BDH Industries Ltd, India Tolnaftate 1%w/v POM Solution for Topical 199/016 BDH Industries Ltd, India Tolfet Solution 814 Use 815 Metacycline Ointment Tetracycline 1%w/v POM Eye Ointment 199/017 BDH Industries Ltd, India 816 Ciprofloxacin Eye Drops Ciprofloxacin 0.3% POM Eye Drops 199/018 BDH Industries Ltd, India Benzoic Acid BP 6%w/w P Ointment topical 199/019 BDH Industries Ltd, India Metaskinton Ointment + Salicylic Acid BP 817 3%w/w Hydrocortisone Acetate Hydrocortisone 1%w/w POM Eye topical 199/020 BDH Industries Ltd, India 818 Ophthalmic Ointment 819 Cevin Tablets Ascorbic Acid 500mg GS Tablet Uncoated 199/021 BDH Industries Ltd, India 820 Mebendazole Tablets Mebendazole 200mg P Tablet Uncoated 199/022 BDH Industries Ltd, India 821 Metagliben Tablets Glibenclamide 5mg POM Tablet Uncoated 199/023 BDH Industries Ltd, India 822 Salbamol-4 Salbutamol 4mg POM Tablet Uncoated 199/024 BDH Industries Ltd, India 823 Metamycin Ointment Chloramphehicol 1%w/v POM Eye Ointment 199/025 BDH Industries Ltd, India 824 Xiprox 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 199/026 BDH Industries Ltd, India 825 Acyclovir Tablets Acyclovir 200mg POM Tablet Uncoated 199/027 BDH Industries Ltd, India 826 Metazole Tablets Metronidazole 200mg POM Tablet Uncoated 199/028 BDH Industries Ltd, India 827 Nalop-20mg Tablets Enalapril 20mg POM Tablet Uncoated 199/029 BDH Industries Ltd, India 828 Napril-10 Tablets Enalapril 10mg POM Tablet Uncoated 199/030 BDH Industries Ltd, India 829 Acetazolamide Tablets Acetazolamide 250mg POM Tablet Uncoated 199/031 BDH Industries Ltd, India 830 Praziquantel Tablets Praziquantel 600mg POM Tablet Uncoated 199/032 BDH Industries Ltd, India Hydrochlorothiazide POM Tablet Uncoated 199/033 BDH Industries Ltd, India Hydrex-50 Tablets 831 50mg 832 CTM Cream Clotrimazole 1%w/w POM Cream Topical 199/034 BDH Industries Ltd, India Ferrous Sulphate and Folic Acid Ferrous sulphate 200mg POM Tablet Uncoated 199/035 BDH Industries Ltd, India 833 Tablets + Folic acid 5mg 834 Metalax Tablets Bisacodyl 5mg POM Tablet Uncoated 199/036 BDH Industries Ltd, India

Page 40 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 835 Griseofulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 199/037 BDH Industries Ltd, India 836 Fluconazole Capsules Fluconazole 200mg POM Capsule oral 199/038 BDH Industries Ltd, India 837 Metphage - 500 Tablets Metformin 500mg POM Tablet Uncoated 199/039 BDH Industries Ltd, India Potassium chloride POM Tablet extended 199/040 BDH Industries Ltd, India Alkay - ER Tablets 838 600mg release Povidone Iodine 10%w/v GS Solution for Topical 199/041 BDH Industries Ltd, India Pi-dine Solution 839 Use Quinine Sulphate BP POM Tablet Uncoated 310/007 BDH Industries Ltd, India Quinine Sulphate BP Tablets 840 300mg Mifepristone 25mg POM Tablet Uncoated 001/001 Beijing Zizhu Pharmaceutical Company Ltd, Mifepristone 25mg Tablets 841 China Misoprostol 200mg POM Tablet Uncoated 001/002 Beijing Zizhu Pharmaceutical Company Ltd, Misoprostol 200mg Tablets 842 China Mifepristone 200mg POM Tablet Uncoated 001/003 Beijing Zizhu Pharmaceutical Company Ltd, Mifepristone 200mg Tablets 843 China Miconazole cream 2% POM Cream Topical 241/001 Beltapharm SPA, Italy Miconazole Cream 844 w/w Betamethasone POM Ointment topical 241/002 Beltapharm SPA, Italy dipropionate 0.5%w/w + Phenylephrine Anti-Haemorrhoid Ointment ch/orhydrate 0.1 %w/w + Lidocaine chlorhydrate 845 2w/w Trimethoprim 40mg + POM Powder for Oral 241/003 Beltapharm SPA, Italy Clotrimazole Powder Sulphamethoxazole Solution 846 200mg/5ml Metronidazole 125mg, POM Powder for Oral 241/004 Beltapharm SPA, Italy Metronidazole Powder 847 per 5ml Solution Nystatin 100,000I.U., per POM Suspension for 241/005 Beltapharm SPA, Italy Nystatin Suspension 848 ml Oral Use Aspirin 600mg + Caffeine GS Tablet Uncoated 102/001 Beta Healthcare International Limited, Action Tablets 50mg + Paracetamol Kenya 849 300mg Action Junior Strawberry Paracetamol 120mg GS Tablet Uncoated 102/002 Beta Healthcare International Limited, 850 Flavoured Tablets Kenya Amylmetacresol 0.6mg + GS Lozenges 102/003 Beta Healthcare International Limited, Strepsils Regular Lozenges 2,4 Dichlorobenzyl Kenya 851 alcohol 1.2mg

Page 41 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Amylmetacresol 0.6mg + GS Lozenges 102/004 Beta Healthcare International Limited, Strepsils Honey & Lemon 2,4 Dichlorobenzyl Kenya Lozenges 852 alcohol 1.2mg Paracetamol 500mg GS Tablet Uncoated 102/005 Beta Healthcare International Limited, Paracetamol Tablets 853 Kenya Tolu 0.04ml + Capsium GS Tablet Uncoated 102/006 Beta Healthcare International Limited, Oleoresin 0.03ml + Kenya Goodmorning Cough Tablet Creosote 2.2mg + Anise oil 1.1mg + Liquorice 854 56.35mg Tolu 0.56ml + Capsium GS Syrup 102/007 Beta Healthcare International Limited, Ticnture 0.25ml + Kenya Goodmorning Lung Tonic Creosote 66.65mg + Anise oil 13.85mg + 855 Liquorice 25mg Aspirin 300mg P Tablet Uncoated 102/009 Beta Healthcare International Limited, Asprin Tablets 856 Kenya Aspirin 324mg GS Tablet Uncoated 102/010 Beta Healthcare International Limited, Aspro Tablets 857 Kenya Amodiaquine 260mg POM Tablet Uncoated 102/011 Beta Healthcare International Limited, Betaquine Tablets 858 Kenya Benzyl benzoate 25g, per P Lotion for Topical 102/012 Beta Healthcare International Limited, Opele Lotion 859 100ml Use Kenya Methyl salicylate 5.0ml + GS Ointment topical 102/013 Beta Healthcare International Limited, Turpentine oil 25ml + Kenya Salimia Linment Ointment Capiscum oleoresin 2.25mg + Camphor 860 2.0mg Sodium bicarbonate GS Solution for Oral 102/014 Beta Healthcare International Limited, Beta Gripe Water 60mg + Dill seed oil Use Kenya 861 2.15mg Tincture Ipecacuanha GS Syrup 102/015 Beta Healthcare International Limited, Prunol Cough Syrup 862 0.12ml, per 5ml Kenya Vitamin D 125IU + GS Powder for Oral 102/016 Beta Healthcare International Limited, Calcium Solution Kenya Glucolin Powder Glycerophosphate 0.5g + Dextrose Monohydrate qs 863 to100g

Page 42 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Vitamin C 0.012g + GS Powder for Oral 102/017 Beta Healthcare International Limited, Glucolin Dynomite Powder Dextrose Monohydrate qs Solution Kenya 864 to 15g Amylmetacresol 0.6mg+ GS Lozenges 102/019 Beta Healthcare International Limited, Betasil Regular Lozenges 2,4 Dichlorobenzyl Kenya 865 Alcohol 1.2 Amylmetacresol 0.6mg + GS Lozenges 102/020 Beta Healthcare International Limited, Beta Herbal Lozenges 2.4 Dichlorobenzyl Alchol Kenya 866 1.2mg Glycyrrhiza Globra 20mg P Tablet Uncoated 102/021L Beta Healthcare International Limited, + Terminalia 5mg + Kenya Memcap Tablets Zingiber 5mg + Curcuma 867 2mg + Metha 7mg Herbal Extracts GS Cream Topical 102/022L Beta Healthcare International Limited, Salima Cream 868 Kenya Dill Seed Oil 2.15mg + GS Solution for Oral 102/023 Beta Healthcare International Limited, Woodwards Gripe Water Sodium Bicarbonate Use Kenya 869 60mg Prednisolone 5mg POM Tablet Uncoated 168/001 Be-Tabs Pharmaceuticals (Pty) Ltd, South Betabs Prednisolone Tablets 870 Africa Phenoxymethyl Penicillin POM Suspension for 168/002 Be-Tabs Pharmaceuticals (Pty) Ltd, South Betapen Suspension 871 V 125mg, per 5ml Oral Use Africa Phenoxymethyl Penicillin POM Tablet Uncoated 168/003 Be-Tabs Pharmaceuticals (Pty) Ltd, South Betapen Tablets 872 V 250mg Africa Clotrimazole 1gm, per POM Cream Topical 168/004 Be-Tabs Pharmaceuticals (Pty) Ltd, South Candarspor Cream 873 100gm Africa Sodium Citrate 135mg + P Syrup 168/005 Be-Tabs Pharmaceuticals (Pty) Ltd, South Ammonium Chloride Africa Clear Cough Syrup 135mg + Diphenhydramine HCL 874 14.1mg/5ml Codeine 7.5mg + P Syrup 168/006 Be-Tabs Pharmaceuticals (Pty) Ltd, South Codef Syrup Ephedrine 15mg + Africa 875 Mepyramine 20mg/15ml Pseudoephedrine 30mg P Syrup 168/007 Be-Tabs Pharmaceuticals (Pty) Ltd, South Drilix Syrup 876 Africa

Page 43 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Dried Aluminium GS Suspension 168/008 Be-Tabs Pharmaceuticals (Pty) Ltd, South Hydrochloride 120mg + Africa Lo-acid Suspension Magnesium Trisilicate 877 250mg Codeine Phosphate P Tablet Uncoated 168/009 Be-Tabs Pharmaceuticals (Pty) Ltd, South 10mg + Caffeine 30mg + Africa B-dol Tablets SC Doxylamine Succinate 5mg + Paracetamol 878 450mg Ascorbic Acid 250mg GS Tablet Uncoated 168/010 Be-Tabs Pharmaceuticals (Pty) Ltd, South Betabs Chewy Tablets 879 Africa Pseudoephedrine P Syrup 168/011 Be-Tabs Pharmaceuticals (Pty) Ltd, South Hydrochloride 30mg/5ml Africa Betafed Syrup + Tripiolidine Hydrochloride 1.25mg, 880 per 5ml Ammonium chloride P Syrup 168/012 Be-Tabs Pharmaceuticals (Pty) Ltd, South 136mg + Africa Betalin Syrup Diphenhydramine HCL 881 14mg/5ml Pseudoephedrine P Syrup 168/013 Be-Tabs Pharmaceuticals (Pty) Ltd, South Hydrochloride 20mg + Africa Trifen Expectorant Adult Syrup Codeine Phosphare 7.5mg + Trivrolidine 882 Hydrochloride 1.25mg Pseudoephedrine P Syrup 168/014 Be-Tabs Pharmaceuticals (Pty) Ltd, South Hydrochloride 12mg + Africa Codeine Phosphate 3mg Trifen Expectorant Child Syrup + Triprolidine Hydrochloride 0.6mg + 883 Guaiphenesin, per 5ml Multivitamins GS Syrup 168/015 Be-Tabs Pharmaceuticals (Pty) Ltd, South Viteral Syrup 884 Africa Povidone Iodine 10%w/v GS Solution for Topical 168/016 Be-Tabs Pharmaceuticals (Pty) Ltd, South Septadine Solution 885 Use Africa Povidone Iodine 10%w/v GS Ointment topical 168/017 Be-Tabs Pharmaceuticals (Pty) Ltd, South Septadine Ointment 886 Africa Hydrochlorthiazide 50mg POM Tablet Uncoated 168/018 Be-Tabs Pharmaceuticals (Pty) Ltd, South Betaretic Tablets 887 + Amiloride 5mg Africa

Page 44 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Paracetamol 320mg + P Tablet Uncoated 168/019 Be-Tabs Pharmaceuticals (Pty) Ltd, South Painagon Tablets Codeine 8mg + Africa 888 Promethazine Vitamins + Minerals P Capsule oral 168/020 Be-Tabs Pharmaceuticals (Pty) Ltd, South Pre-Natal Forte Capsules 889 Africa Paracetamol + Codeine + P Syrup 168/021 Be-Tabs Pharmaceuticals (Pty) Ltd, South Painagon Syrup 890 Caffeine Africa Paracetamol 500mg + P Syrup 168/022 Be-Tabs Pharmaceuticals (Pty) Ltd, South Dextromethorphan Africa Flustat Syrup Hydrobromide 15mg + Phenylpropanolamine 891 HCL 25mg/20ml Ascorbic Acid 75mg + P Capsule oral 168/023 Be-Tabs Pharmaceuticals (Pty) Ltd, South Paracetamol 300mg + Africa Caffeine 30mg + Flustat Capsules Chlorpheniramine Maleate 2mg + 892 Phenylephrine HCL 5mg Mepyramine maleate P Cream Topical 168/024 Be-Tabs Pharmaceuticals (Pty) Ltd, South Be-Tabs Mepyraderm Cream 893 0.2g, per 10g Africa Pyridoxine Hydrochloride POM Tablet Uncoated 168/025 Be-Tabs Pharmaceuticals (Pty) Ltd, South Be-Tabs Pyridoxine Tablets 894 25mg Africa Magnesium Triscillate GS Suspension for 168/026 Be-Tabs Pharmaceuticals (Pty) Ltd, South 500mg + Magnesium Oral Use Africa Be-Tabs Antacids Suspension Carbonate Light 500mg + Sodium Carbonate 895 500mg, per 10ml Folic Acid 5mg POM Tablet Uncoated 168/027 Be-Tabs Pharmaceuticals (Pty) Ltd, South Be-Tabs Folic Acid Tablets 896 Africa Potassium Citrate 1.2g + P Solution for Oral 168/028 Be-Tabs Pharmaceuticals (Pty) Ltd, South Crystacist Solution 100mg Citric acid Monohydrate Use Africa 897 200mg, per 15ml Mebendazole 500mg P Tablet Uncoated 168/029 Be-Tabs Pharmaceuticals (Pty) Ltd, South Wormstop Tablets 898 Africa Propofol 1% POM Solution for 233/001 Bharat Biotech Ltd, India Propovan Injection 899 Injection Antihymocyte Globulin- POM Solution for 233/003 Bharat Biotech Ltd, India Thymogam Globulin Injection equine 250mg, per Injection 900 100mg

Page 45 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Recombinant Human POM Gel Topical 279/046 Bharat Biotech Ltd, India Epidermal Growth Factor Regen-D Gel 150mcg, per gram 901 Indirab Rabies Vaccine BP + Rabies vaccine BP 2.5IU, POM Solution for 233/004 Bharat Biotech Ltd, India Diluent for Indirab Injection 05ml + Sodium Chloride Injection 902 IP 0.3% w/v, Rhus toxicodendron 10% GS Solution for Topical 371/001 Bhargava Phytolab Pvt, India + Bryonia alba 20% + Use Terebinthena oleum 20% Rhomo Oil + Camphor 20% + Menthol 10% + Thymol 10% + Symphytum 903 officinalis 10% 904 Angel Gloss Cream Herbal Preparation P Cream Topical 389/001L Bhargava Phytolab Pvt, India Aluminium Hydroxide GS Tablets chewable 389/002L Bhargava Phytolab Pvt, India 100mg + Bismuth Carbonicum 75mg + Gass Off Tablets Magnesium Hydroxide 100mg + Natrum Bicarbonicum 75mg + 905 Herbal Extracts 906 Meniphib Tablets Herbal preparation P Tablets film coated 389/003L Bhargava Phytolab Pvt, India 907 Co-Ex Syrup Herbal Preparation P Syrup 389/004 Bhargava Phytolab Pvt, India Cisplatin 10mg POM Powder for 240/001 Biochem Pharmaceuticals industries Ltd, Ciplast 10mg Injection 908 Injection India Cyclophosphamide 1g POM Solution for 240/002 Biochem Pharmaceuticals industries Ltd, Cycloxan 1g Injection 909 Injection India Cyclophosphamide POM Powder for 240/003 Biochem Pharmaceuticals industries Ltd, Cycloxan 500mg Injection 910 500mg Injection India Fluorouracil 500mg, per POM Solution for 240/004 Biochem Pharmaceuticals industries Ltd, Flucracil 500mg/10ml Injection 911 10ml Injection India Tamoxifen 10mg POM Tablet Uncoated 240/005 Biochem Pharmaceuticals industries Ltd, Tamodex Citrate Tablets 912 India Etoposide 100mg, per POM Powder for 240/006 Biochem Pharmaceuticals industries Ltd, Bioposide 100mg Injection 913 5ml Injection India Methotrexate 2.5mg POM Tablet Uncoated 240/007 Biochem Pharmaceuticals industries Ltd, Biotrexate 2.5mg Tablets 914 India

Page 46 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Methotrexate 25mg, per POM Solution for 240/008 Biochem Pharmaceuticals industries Ltd, Biotrexate Injection 915 ml Injection India Cisplatin 50mg POM Powder for 240/010 Biochem Pharmaceuticals industries Ltd, Cisplat 50mg Injection 916 Injection India Cyclophosphamide 50mg POM Solution for 240/011 Biochem Pharmaceuticals industries Ltd, Cycloxan 50mg Injection 917 Injection India Doxorubicin 50mg POM Solution for 240/012 Biochem Pharmaceuticals industries Ltd, Doxorubicin Injection 918 Injection India Fluorouracil 500mg, per POM Solution for 240/013 Biochem Pharmaceuticals industries Ltd, Fluracil 250mg/10ml Injection 919 10ml Injection India Paclitaxel 6mg, per ml POM Powder for 240/015 Biochem Pharmaceuticals industries Ltd, Petaxel 30mg/5ml Injection 920 Injection India Vincristine 1mg POM Powder for 240/016 Biochem Pharmaceuticals industries Ltd, Biocristin Injection 921 Injection India Tamoxifen 20mg POM Tablet Uncoated 240/017 Biochem Pharmaceuticals industries Ltd, Tamodex 20 Tablets 922 India Paclitaxel 6mg, per ml POM Powder for 240/018 Biochem Pharmaceuticals industries Ltd, Pataxel 260 Injection 923 Injection India Folic acid 50mg, per 5ml POM Solution for 240/019 Biochem Pharmaceuticals industries Ltd, Biovorin Injection 924 Injection India Carboplatin 10mg, per ml POM Powder for 240/020 Biochem Pharmaceuticals industries Ltd, Biocarb 150 Injection 925 Injection India Carboplatin 450mg POM Powder for 240/021 Biochem Pharmaceuticals industries Ltd, Biocarb 450 Injection 926 Injection India Cyclophosphamide 50mg POM Tablet Uncoated 240/022 Biochem Pharmaceuticals industries Ltd, Cycloxan 50mg Tablets 927 India Cyclophosphamide POM Solution for 240/023 Biochem Pharmaceuticals industries Ltd, Cycloxan 200 Injection 928 200mg Injection India Letrozole 2.5mg POM Tablet Film coated 240/024 Biochem Pharmaceuticals industries Ltd, Oncolet Tablets 929 India Cyclophosphamide 50mg POM Tablet Film coated 290/022 Biochem Pharmaceuticals industries Ltd, Cycloxan Tablets 930 India Insulin 100IU, per ml POM Suspension for 305/001 Biocon Limited, India Insugen -R Injection 931 Injection Insugen -30/70 (Biphasic) Insulin 30/70 POM Suspension for 305/002 Biocon Limited, India 932 Injection Injection Insulin 100IU POM Suspension for 305/003 Biocon Limited, India Insugen - N (NPH) Injection 933 Injection 934 Biomol Tablets Paracetamol BP 500mg P Tablet Uncoated 020/001 Biodeal Laboratories Pvt Ltd, India

Page 47 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 935 Biovir Cream Aciclovir BP 5% w/w POM Cream Topical 020/002 Biodeal Laboratories Pvt Ltd, India One Q Gummy with Colostrum Colostrum Powder 30mg P Capsule oral 353/001L Biofact Life SND. BHD Ltd, Malysia 936 (Lemon Flavour) One Q Gummy with Vitamin C Vitamin C 40mg P Capsule oral 353/002L Biofact Life SND. BHD Ltd, Malysia 937 (Orange Flavour) One Q Gummy with Multivitamins & Minerals P Capsule oral 353/003L Biofact Life SND. BHD Ltd, Malysia Multivitamins (Strawberry 938 Flavour) Omega 3 8.6mg Total P Capsule oral 353/004L Biofact Life SND. BHD Ltd, Malysia One Q Gummy with Omega 3 939 EPA& DHA 7.9mg Acai Berry 25mg + P Capsule oral 353/005L Biofact Life SND. BHD Ltd, Malysia One Q Gummy with Acai Berry Lutein 10% powder And Luten 940 10mg Fluocinolone Acetonide P Gel Topical 023/018 Bioglan Laboratories Limited, UK Synalar Gel 941 Ph. Eur. 0.025% w/w Fluocinolone Acetonide P Cream Topical 023/019 Bioglan Laboratories Limited, UK Synalar C Cream 942 0.025% + Clioquinol 3% Fluocinolone Acetonide P Cream Topical 023/032 Bioglan Laboratories Limited, UK Synalar Cream 943 Ph. Eur. 0.025% w/w Fluocinolone Acetonide P Ointment topical 023/033 Bioglan Laboratories Limited, UK Synalar Ointment 944 Ph. Eur. 0.025% w/w (Fluocinolone Acetonide P Cream Topical 023/034 Bioglan Laboratories Limited, UK 0.25mg + Neomycin Synalar N Cream Sulphate 3500 IU), per 945 gram) Fluocinolone Acetonide P Ointment topical 023/035 Bioglan Laboratories Limited, UK 0.25mg, per g) + Synalar N Ointment Neomycin Sulphate 946 (3500 IU, per g) 947 Cetavlex Antiseptic Cream Cetrimide Solution BP P Cream Topical 235/001 Bioglan Laboratories Limited, UK Calcium Citrate 1000mg P Tablet Uncoated 304/001 Bioplus Lifesciences Ltd, India + Magnesium Hydroxide Supracal Tablets 239.9mg + Zinc Sulphate Monohydrate 10.978mg 948 949 Gvfluc 200 Capsules Fluconazole 200mg POM Capsule oral 245/001 Bliss GVS Pharma Ltd, India Artemether 300mg, per POM Suspension for 245/002 Bliss GVS Pharma Ltd, India Gvither Oral Suspension 950 100ml Oral Use

Page 48 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Clotrimazole 1.0%w/w + POM Cream Topical 245/003 Bliss GVS Pharma Ltd, India Neomycin sulphate Funbact A Cream 0.5%w/w + Betamethasone 951 0.05%w/w 952 Comit-50 Tablets Sildenafil 50mg POM Tablet Uncoated 245/004 Bliss GVS Pharma Ltd, India 953 Lofnac 100 Tablets Diclofenac 100mg P Tablet Uncoated 245/005 Bliss GVS Pharma Ltd, India Diclofenac 1.16%w/w + P Gel Topical 245/006 Bliss GVS Pharma Ltd, India Linseed Oil 3%w/w + Lofnac Gel Methyl Salicylate 10%w/w + Menthol 954 5%w/v Artemether 80mg, per ml POM Powder for 245/010 Bliss GVS Pharma Ltd, India Gvither Forte Injection 955 Injection Artesunate tablet 200mg POM Tablet Uncoated 245/011 Bliss GVS Pharma Ltd, India Gsunate Kit Tablets + Amodiaquine HCl BP 956 tablet 600mg Amodiaquine BP 600mg POM Tablet Uncoated 245/012 Bliss GVS Pharma Ltd, India tablet + Alaxin Kit Tablets Dihydroartemisinin 957 160mg tablets Artemether 20mg + POM Tablet Uncoated 245/013 Bliss GVS Pharma Ltd, India Lonart Tablets 958 Lumefantrine 120mg Artemether 40mg + POM Tablet Uncoated 245/014 Bliss GVS Pharma Ltd, India Lonart Forte Tablets 959 Lumefantrine 240mg Artemether 20mg + POM Suspension for 245/015 Bliss GVS Pharma Ltd, India Lonart Suspension Lumefantrine 120mg, per Oral Use 960 5ml Amoxicillin 125mg + POM Suspension for 245/016 Bliss GVS Pharma Ltd, India Clamoxin 125 Suspension Clavulanic Acid 125mg, Oral Use 961 per 5ml Amoxicillin 250mg + POM Suspension for 245/017 Bliss GVS Pharma Ltd, India Clamoxin 250 Suspension Clavulanic Acid 62.5mg, Oral Use 962 per 5ml 963 Today Pill Levonorgestrel 0.75mg POM Tablet Uncoated 245/018 Bliss GVS Pharma Ltd, India 964 Lofnac - 50 Tablets Diclofenac 50mg P Tablet Uncoated 245/019 Bliss GVS Pharma Ltd, India Diclofenac 50mg + P Tablet Uncoated 245/020 Bliss GVS Pharma Ltd, India Lofnac - P Tablets 965 Paracetamol 500mg

Page 49 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Sulfadoxine 500mg + POM Tablet Uncoated 245/021 Bliss GVS Pharma Ltd, India Paludoxin Tablets 966 Pyrimethamine 25mg Lonart Dispersible Tablets For Artemether 20mg + POM Tablet Dispersible 245/022 Bliss GVS Pharma Ltd, India 967 Infants And Children Lumefantrine120mg Clindamycin 100mg + POM Suppository 245/023 Bliss GVS Pharma Ltd, India Vagid -CL Suppositories 968 Clotrimazole 200mg 969 Glycerin Suppositories Glycerin 90%w/w P Suppository 245/024 Bliss GVS Pharma Ltd, India 970 Slipizem -5 Suppositories Diazepam 5mg POM Suppository 245/025 Bliss GVS Pharma Ltd, India Vitamin B12 2.5 mg + P Syrup 245/026 Bliss GVS Pharma Ltd, India Vitamin B1 1mg + Niacinamide 15mg + Amitone Syrup Vitamin B2 1.5mg + Vitamin B 6 0.5mg + Sorbitol 70% + Lysine 971 50mg + Choline 30mg Ferric Ammonium Citrate P Syrup 245/028 Bliss GVS Pharma Ltd, India 200mg + Folic Acid Gynofer B12 Syrup 1.5mg + Vitamin B12 972 50mg 973 Sirofen Syrup Ibuprofen 20mg P Syrup 245/031 Bliss GVS Pharma Ltd, India Paracetamol 0.500g + P Granules for 245/032 Bliss GVS Pharma Ltd, India Rinogrip Granules Chlorpheniramine 0.025g Suspension 974 + Ascorbic Acid 0.2g 975 Recticin 100 Suppositories Indomethacin 100mg POM Suppository 264/001 Bliss GVS Pharma Ltd, India Allantoin 0.5% + Zinc POM Suppository 264/002 Bliss GVS Pharma Ltd, India Oxide 5% + Lidocaine Anomex Suppositories 3% + Hydrocortisone 976 0.25% 977 Vagid Pessaries Clotrimazole 100mg POM Tablet Vaginal 264/003 Bliss GVS Pharma Ltd, India Dihydroartemisinin POM Suspension 245/007 BlissGVS Pharma Ltd, India Alaxin Oral Suspension 978 160mg, per 80ml 979 Alaxin Tablets Dihydroartemisinin 60mg POM Tablet Uncoated 245/008 BlissGVS Pharma Ltd, India 980 Gsunate Forte Tablets Artesuate 100mg POM Tablet Uncoated 245/009 BlissGVS Pharma Ltd, India 981 Bgmet Tablets Metformin 500mg POM Tablet Uncoated 245/027 BlissGVS Pharma Ltd, India 982 Azitrine Tablets Azithromycin 250mg POM Tablet Uncoated 245/029 BlissGVS Pharma Ltd, India Dihydroartemisinin 80mg POM Tablet Uncoated 245/030 BlissGVS Pharma Ltd, India P-Alaxin Tablets + Piperaquine Phosphate 983 320mg 984 Glycoben Tablets Glibenclamide 5mg POM Tablet Uncoated 245/030 BlissGVS Pharma Ltd, India

Page 50 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Chloramphenicol 1% Opthalmic Chloramphehicol 10mg POM Eye Ointment 245/033 BlissGVS Pharma Ltd, India 985 Ointment USP Silver Sulphadiazine POM Cream Topical 245/034 BlissGVS Pharma Ltd, India Hilderm - CH Cream 1%w/w + Chitosan2%w/w 986 Tetracycline 1% Opthalmic Tetracycline 10mg POM Eye Ointment 245/035 BlissGVS Pharma Ltd, India 987 Ointment USP Clobetasol propionate POM Cream Topical 245/036 BlissGVS Pharma Ltd, India BG-Sol Cream 988 0.05%w/w PEG 1500 80%w/w + P Tablet Vaginal 245/037 BlissGVS Pharma Ltd, India Maitri Vaginal Lubricant 989 PEG 1000 20%w/w 990 Asnorbin - 1000 Tablets Ascorbic Acid 1000mg P Tablet Uncoated 245/038 BlissGVS Pharma Ltd, India Paracetamol 500mg + P Tablet Uncoated 245/039 BlissGVS Pharma Ltd, India Caffeine 30mg + BG-Cold Tablets Chlorpheniramine 5mg + 991 Phenylephrine 2mg Clindamycin Phosphate POM Gel Topical 245/040 BlissGVS Pharma Ltd, India Pip - Off Gel 992 1.0%w/v L-Glutamic Acid 100mg + P Syrup 245/041 BlissGVS Pharma Ltd, India Thiamine Hydrochloride 4.5mg + Pyridoxine BG-Glutamin Syrup Hydrochloride 1.5mg + Cyano 5mcg 993 Dihydroartemisinin 80mg POM Suspension 245/042 BlissGVS Pharma Ltd, India P-Alaxin Suspension + Piperaquine Phosphate 994 640mg Artemether 80mg + POM Tablet Uncoated 245/043 BlissGVS Pharma Ltd, India Lonart DS Tablets 995 Lumefantrine 480mg Mefenamic Acid 100mg, P Suspension for 245/046 BlissGVS Pharma Ltd, India BG - Fenamex Suspesion 996 per 5ml Oral Use 997 Gacet - 500mg Tablets Paracetamol 500mg GS Tablet Uncoated 254/045 BlissGVS Pharma Ltd, India L-Glutamic Acid BP P Tablet Oral 254/046 BlissGVS Pharma Ltd, India 250mg + Thiamine Hydrochloride BP 10mg + BG-Glutamin Tablets Pyridoxine Hydrochloride BP 3mg + Cyanocobalamine 10mcg 998

Page 51 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 999 Secnagyl Tablets Secnidazole 1.0g POM Tablet Uncoated 254/047 BlissGVS Pharma Ltd, India Vitamin A 1000IU + P Syrup 254/048 BlissGVS Pharma Ltd, India Vitamin D3 200IU + Vitamin B1 1.5mg + Vitamin B2 1.0 mg + Vitavit Multivitamin Syrup Vitamin B6 1.0mg + Vitamin C 30.0mg + Nicotinamide 10.0mg + 1000 Panthenol 5.0mg Ambroxol Hydrochloride P Syrup 254/049 BlissGVS Pharma Ltd, India BP 15mg + Guaiphenesin BP 50mg + Terbutaline Broxol Syrup Sulphate BP 1.5mg + Menthol BP 1mg 1001 Pantoprazole sodium POM Tablet Uncoated 254/050 BlissGVS Pharma Ltd, India Upracid -40 Tablets 1002 sesquihydrate BP 40mg Cefuroxime Axetil USP POM Powder for Oral 254/051 BlissGVS Pharma Ltd, India Sanfurox - DS 125 Suspension 1003 125mg, per 5ml Suspension Sildenafil Citrate I.H POM Tablet Uncoated 254/052 BlissGVS Pharma Ltd, India Comit -100 Tablets 1004 100mg Metformin Hydrochloride POM Tablet Uncoated 254/053 BlissGVS Pharma Ltd, India BG - MET 850 Tablets 1005 BP 850mg Amino Acids and POM Syrup 254/054 BlissGVS Pharma Ltd, India X-Tone Forte Syrup 1006 Minerals Azithromycin Dihydrate POM Tablet Uncoated 254/055 BlissGVS Pharma Ltd, India Agycin 500 Tablets 1007 USP 500mg Paracetamol 325mg + P Tablet Uncoated 254/056 BlissGVS Pharma Ltd, India Finmol Plus Capsules Ibuprofen BP 200mg + 1008 Caffeine 30mg 1009 Vagid 500 Clotrimazole BP 500mg POM Tablet Vaginal 254/057 BlissGVS Pharma Ltd, India Pantoprazole 40mg + POM Capsule oral 254/058 BlissGVS Pharma Ltd, India Prodone Imazole Capsules 1010 Domperidone BP 30mg 1011 Conlax-5 Suppositories Bisacodyl USP 5mg POM Suppository 254/059 BlissGVS Pharma Ltd, India 1012 Conlax-10 Suppositories Bisacodyl USP 10mg POM Suppository 254/060 BlissGVS Pharma Ltd, India 1013 Fibrotin Tablets Fenofibrate BP 160mg POM Tablet Film coated 254/061 BlissGVS Pharma Ltd, India 1014 Comit-100 Oral Jelly Sildenafil 100mg POM Gel Oral 254/062 BlissGVS Pharma Ltd, India

Page 52 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER LOFNAC BALM Mentha piperita 6%w/w + P Ointment topical 254/071L BlissGVS Pharma Ltd, India Cinnamomum camhora 5.5%w/w + Pinus longifolia roxb 5%w/w + Pytchotis ajowan 2%w/w + Wintergreen oil 24%w/w Eucalyptus globulus labill 5%w/w 1015 LOFNAC ROLL - ON Pytchotis ajowan P Gel Topical 254/072L BlissGVS Pharma Ltd, India 0.5%w/v + Mentha piperita 3%w/v + Cinnamomum camhora 2%w/v + Eucalyptus globulus labill 0.5%w/v + Wintergreen oil 15%wv/v Pinus longifolia roxb 1016 1%w/v 1017 Sunfurox 500 Tablets Cefuroxime axetil 500mg POM Tablet Film coated 254/066 BlissGVS Pharma Ltd, India X-pro 500 Tablets Ciprofloxacin POM Tablet Film coated 254/067 BlissGVS Pharma Ltd, India 1018 hydrochloride 500mg Clamoxin 625 Tablets Amoxicillin trihydrate POM Tablet Film coated 254/068 BlissGVS Pharma Ltd, India 500mg + Clavulanate 1019 Potassium 125mg Clamoxin 1g Tablets Amoxicillin trihydrate POM Tablet Film coated 254/069 BlissGVS Pharma Ltd, India 875mg + Clavulanate 1020 Potassium 125mg 1021 Uprone 20 capsules Omeprazole 20mg POM Capsule oral 254/070 BlissGVS Pharma Ltd, India 1022 Agycin Suspension Azithromycin 40mg/ml POM Suspension 254/073 BlissGVS Pharma Ltd, India Gacet 250 Suppositories Acetaminophen USP POM Suppository 254/076 BlissGVS Pharma Ltd, India 1023 250mg Gacet 125 Suppositories Acetaminophen USP POM Suppository 254/075 BlissGVS Pharma Ltd, India 1024 125mg G-SUNATE Injection Artesunate BP 60mg POM Solution for 254/074 BlissGVS Pharma Ltd, India 1025 Injection Adrenaline 1.0mg, per ml POM Solution for 254/001 Bodene(PTY) Ltd, South Africa Adrenaline-Fresenius Injection 1026 Injection Chlorpromazine Hydrochloride Chlorpromazine 25mg, POM Solution for 254/002 Bodene(PTY) Ltd, South Africa 1027 Injection per ml Injection

Page 53 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Dextrose 50% w/v POM Solution for 254/003 Bodene(PTY) Ltd, South Africa Dextrose-Fresenius Injection 1028 infusion Dobutamine 250mg, per POM Solution for 254/004 Bodene(PTY) Ltd, South Africa Dobutamine-Fresenius Injection 1029 20ml Injection Ergometrine Maleate -Fresenius Ergometrine 0.5mg, per POM Solution for 254/005 Bodene(PTY) Ltd, South Africa 1030 Injection ml Injection Fentanyl 100mcg, per POM Solution for 254/006 Bodene(PTY) Ltd, South Africa Fentanyl-Frenesius Injection 1031 2ml Injection Furosemide 20mg, per POM Solution for 254/007 Bodene(PTY) Ltd, South Africa Furosemide-Fresenius Injection 1032 2ml Injection Heparin sodium 25,000IU, per Heparin 25000IU , per ml POM Solution for 254/008 Bodene(PTY) Ltd, South Africa 1033 ml Injection Injection Heparin 5,000IU, per ml Sodium Heparin 5000IU, per ml POM Solution for 254/009 Bodene(PTY) Ltd, South Africa 1034 Injection Injection Mannitol 100g, per 500ml POM Solution for 254/010 Bodene(PTY) Ltd, South Africa Intramed Mannitol 20 Injection 1035 infusion Intramed Sodium Bicarbonate Sodium Bicarbonate POM Solution for 254/011 Bodene(PTY) Ltd, South Africa 1036 Injection 4.25g, per 50ml infusion Metronidazole 500mg, POM Solution for 254/012 Bodene(PTY) Ltd, South Africa Intramed Trichazole Injection 1037 per 100ml infusion Ketamine 50mg, per ml POM Solution for 254/013 Bodene(PTY) Ltd, South Africa Ketamine Injection 1038 Injection Lignocaine 10mg, per POM Solution for 254/014 Bodene(PTY) Ltd, South Africa Lignocaine 1% Injection 1039 2ml Injection Lignocaine 20mg, per ml POM Solution for 254/015 Bodene(PTY) Ltd, South Africa Lignocaine 2% Injection, 20ml 1040 Injection Lignocaine 100mg, per POM Solution for 254/016 Bodene(PTY) Ltd, South Africa Lignocaine 2% Injection, 5ml 1041 5ml Injection Morphine 10mg, per ml POM Solution for 254/017 Bodene(PTY) Ltd, South Africa Morphine Sulphate 10 Injection 1042 Injection Morphine 15mg, per ml POM Solution for 254/018 Bodene(PTY) Ltd, South Africa Morphine Sulphate 15 Injection 1043 Injection Naloxone Neonatal-Fresenius Naloxone 0.042mg, per POM Solution for 254/019 Bodene(PTY) Ltd, South Africa 1044 0.02mg/ml Injection 2ml Injection Naloxone-Fresenius 0.4mg/ml Naloxone 0.42mg, per ml POM Solution for 254/020 Bodene(PTY) Ltd, South Africa 1045 Injection Injection Neostigmine 0.5mg, per POM Solution for 254/021 Bodene(PTY) Ltd, South Africa Neostigmine 0.5 Injection 1046 ml Injection

Page 54 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Neostigmine 2.5mg, per POM Solution for 254/022 Bodene(PTY) Ltd, South Africa Neostigmine 2.5 Injection 1047 ml Injection Pancuronium 4mg, per POM Solution for 254/023 Bodene(PTY) Ltd, South Africa Pancuronium Bromide Injection 1048 2ml Injection Pethidine 100mg, per 2ml POM Solution for 254/024 Bodene(PTY) Ltd, South Africa Pethidine 100 Injection 1049 Injection Pethidine 50mg, per ml POM Solution for 254/025 Bodene(PTY) Ltd, South Africa Pethidine 50 Injection 1050 Injection Promethazine 25mg, per POM Solution for 254/026 Bodene(PTY) Ltd, South Africa Promethazine Injection 1051 ml Injection Quinine 300mg, per ml POM Solution for 254/027 Bodene(PTY) Ltd, South Africa Quinine Injection 1052 Injection Suxamethonium Chloride Suxamethonium 100mg, POM Solution for 254/028 Bodene(PTY) Ltd, South Africa 1053 Injection per 2ml Injection Thiopentone 500mg, per POM Solution for 254/029 Bodene(PTY) Ltd, South Africa Thiopentone Sodium Injection 1054 20ml Injection Fresenius - Hyoscine Butyl Hyoscine ButylBromide POM Solution for 254/040 Bodene(PTY) Ltd, South Africa 1055 Bromide Injection 20mg, per ml Injection Promethazine Hydrochloride Promethazine 50mg, per POM Solution for 254/042 Bodene(PTY) Ltd, South Africa 1056 Fresenius Injection 2ml Injection Nevirapine 200mg POM Tablet Uncoated 119/001 Boehringer Ingelheim Pharmaceuticals (Pty) Viramune Tablets 1057 Ltd, SA Nevirapine 50mg, per POM Suspension 119/002 Boehringer Ingelheim Pharmaceuticals (Pty) Viramune Suspension 1058 5ml Ltd, SA Sodium Bicarbonate P Suspension for 318/001 Bricved Ltd,Republic of Ireland 133.5mg + Sodium Oral Use Acidex Oral Suspension Alginate 250mg + Calcium Carbonate 1059 80mg

Page 55 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Vitamin B1 5mg + P Syrup 318/002 Bricved Ltd,Republic of Ireland Vitamin B2 2mg + Vitamin B6 2mg + Vitamin B12 6mcg + Nicotinamide 20mg + Calcium Pantothenate 10mg +Liver extract 1.175% w/v + Folic Acid Pinoplex Fortified Blood Tonic 0.3mg +Sodium Glycerophosphate 300mg +Potassium Glycerophosphate BPC 49 20mg +Manganese Sulphate 4mg + Ferric Ammonium Sulphate 73mg + Caffeine 57mg 1060 Citric Acid 177mg/30mls Haemoglobin powder P Syrup 318/003 Bricved Ltd,Republic of Ireland HB 12 Syrup 0.5g + Vitamin B12 1061 20mcg, per 5mls Ondansetron 2mg POM Powder for 065/001 Cachet Pharmaceuticals Ltd, India Emitino Injection 1062 Injection Emitino Mouth Dissolving Ondansetron 4mg POM Tablet Uncoated 065/002 Cachet Pharmaceuticals Ltd, India 1063 Tablets Ondansetron 2mg, per POM Solution for Oral 065/003 Cachet Pharmaceuticals Ltd, India Emitino Solution 1064 5ml Use Iron Sucrose 100mg, per POM Solution for 065/004 Cachet Pharmaceuticals Ltd, India I-Up Injection 1065 5ml Injection Meropenem 500mg POM Powder for 065/005 Cachet Pharmaceuticals Ltd, India Canem 500mg Injection 1066 Injection Erythromycin 125mg, per POM Suspension for 065/006 Cachet Pharmaceuticals Ltd, India Erycach Suspension 1067 5ml Oral Use 1068 Erycach 250 Tablets Erythromycin 250mg POM Tablet Film coated 065/007 Cachet Pharmaceuticals Ltd, India 1069 Celza 250mg Tablets Cefuroxime 250mg POM Tablet Uncoated 065/008 Cachet Pharmaceuticals Ltd, India 1070 Celza 500mg Tablets Cefuroxime 500mg POM Tablet Uncoated 065/009 Cachet Pharmaceuticals Ltd, India Amoxycillin Trihydrate POM Tablet Uncoated 065/010 Cachet Pharmaceuticals Ltd, India Acinet 600mg Tablets 500mg + Clavulanate 1071 Potassium 100mg

Page 56 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Amoxicillin Trihydrate POM Tablet Uncoated 065/011 Cachet Pharmaceuticals Ltd, India Acinet 625mg Tablets 500mg + Clavulanate 1072 Potassium 125mg Amoxycillin Trihydrate POM Suspension for 065/012 Cachet Pharmaceuticals Ltd, India Acinet 228.5mg Suspension 200mg + Clavulanate Oral Use 1073 Potassium 28.5mg Alpha Lipoic Acid 100mg P Capsule oral 065/013 Cachet Pharmaceuticals Ltd, India + Gamma Linolenic Acid 60mg + Pyridoxine 3mg + Cachnerve Capsules Methycobalamin 1.5mg + Chromium 50mg 1074 Bromhexine 4mg + P Syrup 065/014 Cachet Pharmaceuticals Ltd, India Salbutamol 2mg + Eascof Expectorant Syrup Guaifenesin 100mg + 1075 Menthol 1mg 1076 Trama 50 Capsules Tramadol 50mg POM Capsule oral 065/015 Cachet Pharmaceuticals Ltd, India Tramadol 37.5mg + POM Tablet Uncoated 065/016 Cachet Pharmaceuticals Ltd, India Tramacetal Tablets 1077 Paracetamol 25mg Artemether 20mg + POM Tablet Uncoated 065/017 Cachet Pharmaceuticals Ltd, India Cach - ART 20/120 Tablets 1078 Lumefantrine 120mg Paracetamol 125mg, per GS Suspension for 065/018 Cachet Pharmaceuticals Ltd, India Cachpar Suspension 1079 5mg Oral Use Cefuroxime 125mg, per POM Powder for Oral 065/019 Cachet Pharmaceuticals Ltd, India Celza Dry Syrup 1080 5ml Suspension Amoxycillin 875mg + POM Tablet Uncoated 065/020 Cachet Pharmaceuticals Ltd, India Acinet 1000mg Tablets 1081 Clavulanate 125mg 1082 Cabalin -75 Capsules Pregabalin 75mg POM Capsule oral 065/021 Cachet Pharmaceuticals Ltd, India (Probiotics: L.Acidophi/u P Powder for Oral 065/022 Cachet Pharmaceuticals Ltd, India + B.longum + B.bifidum + Suspension B.lactis) 5 billions Actilosa Dry Syrup Prebiotics inulin(FOS)Fructo 1083 Oligosaccharide 25mq)

Page 57 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER (Probiotics: P Capsule oral 065/023 Cachet Pharmaceuticals Ltd, India L.Acidophilu+B.longum + B.bifidughm + Blactice) 5 Actilosa Capsules billions prebiotics inulin(FOS)Fructo 1084 Oliqosaccharide) 25mq Meropenem Trihydrate POM Powder for 065/024 Cachet Pharmaceuticals Ltd, India Canem Powder For Injection 1085 1g Injection Amoxicillin Trihydrate POM Caplets oral 065/025 Cachet Pharmaceuticals Ltd, India Moximon Capsules 1086 250mg Uncoated Linseed oil 3.0% w/v + P Gel Topical 065/026 Cachet Pharmaceuticals Ltd, India Diclofenac Diethylamine Lysoflam Gel 1.16% w/v + Methyl Salicylate 12.0% w/v + 1087 Menthol 5.5% w/v Ceftriaxone for Injection POM Solution for 065/027 Cachet Pharmaceuticals Ltd, India Traxol 1000 1088 USP 1000mg Injection 1089 Perflobid 400 Tablets Pefloxacin 400mg POM Tablet Uncoated 113/001 Cadilla Pharmaceuticals Limited, India 1090 Vivorax Tablets Acyclovir 200mg POM Tablet Uncoated 113/002 Cadilla Pharmaceuticals Limited, India 1091 Aciloc 300 Tablets Ranitidine 300mg POM Tablet Film coated 113/003 Cadilla Pharmaceuticals Limited, India 1092 Aciloc 150 Tablets Ranitidine 150mg POM Tablet Uncoated 113/004 Cadilla Pharmaceuticals Limited, India 1093 Amdepin 10 Tablets Amlodipine 10mg POM Tablet Uncoated 113/005 Cadilla Pharmaceuticals Limited, India Amlodipine Besylate 5mg POM Tablet Uncoated 113/006 Cadilla Pharmaceuticals Limited, India Amidepin 5 Tablets 1094 Ciprofloxacin 2mg, per ml POM Solution for 113/007 Cadilla Pharmaceuticals Limited, India Ciprodac Infusion 1095 Infusion 1096 Lovalip 20mg Tablets Lovastatin 20mg POM Tablet Uncoated 113/009 Cadilla Pharmaceuticals Limited, India 1097 Ciprodac 250mg Tablets Ciprofloxacin 250mg POM Tablet Uncoated 113/011 Cadilla Pharmaceuticals Limited, India 1098 Olit 20 Capsules Omeprazole 20mg POM Capsule oral 113/012 Cadilla Pharmaceuticals Limited, India 1099 Pirofen 20 Capsules Piroxicam 20mg POM Capsule oral 113/013 Cadilla Pharmaceuticals Limited, India Fluconazole 2mg, per POM Solution for 113/014 Cadilla Pharmaceuticals Limited, India Fluzon Infusion 1100 1ml infusion 1101 Fluzon 150mg Tablets Fluconazole 150mg POM Tablet Uncoated 113/015 Cadilla Pharmaceuticals Limited, India 1102 Fluzon 100mg Tablets Fluconazole 100mg POM Tablet Uncoated 113/016 Cadilla Pharmaceuticals Limited, India 1103 Wormin A 400mg Tablets Albendazole 400mg POM Tablet Uncoated 113/017 Cadilla Pharmaceuticals Limited, India 1104 Roxibid 150 Tablets Roxithromycin 150mg POM Tablet Uncoated 113/018 Cadilla Pharmaceuticals Limited, India 1105 Gempar 300 Capsules Gemfibrozil 300mg POM Capsule oral 113/019 Cadilla Pharmaceuticals Limited, India Cefotaxime 1000mg POM Powder for 113/020 Cadilla Pharmaceuticals Limited, India Oritaxim 1000mg Injection 1106 Injection

Page 58 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 1107 Envas 2.5mg Tablets Enalapril 2.5mg POM Tablet Uncoated 113/021 Cadilla Pharmaceuticals Limited, India 1108 Cefamor 250mg Capsules Cephalexin 250mg POM Capsule oral 113/022 Cadilla Pharmaceuticals Limited, India Mebendazole 100mg, per P Suspension for 113/023 Cadilla Pharmaceuticals Limited, India Wormin Suspension 1109 5ml Oral Use 1110 Cefamor 500mg Capsules Cephalexin 500mg POM Capsule oral 113/024 Cadilla Pharmaceuticals Limited, India 1111 Dolac 10mg Tablets Ketorolac 10mg POM Tablet Uncoated 113/025 Cadilla Pharmaceuticals Limited, India Ergotamine Tartrate 1mg POM Tablet Uncoated 113/026 Cadilla Pharmaceuticals Limited, India + Prochlorperazine Vasograin Tablets Maleate 2.5mg + Caffeine 100mg + 1112 Paracetamol 250mg 1113 Pirofen 10mg Capsules Piroxicam 10mg POM Capsule oral 113/027 Cadilla Pharmaceuticals Limited, India 1114 Glamide 5mg Tablets Glibenclamide 5mg POM Tablet Uncoated 113/028 Cadilla Pharmaceuticals Limited, India 1115 Fludac 20mg Capsules Fluxetine 20mg POM Capsule oral 113/029 Cadilla Pharmaceuticals Limited, India 1116 Wormin 100mg Tablets Mebendazole 100mg P Tablet Uncoated 113/030 Cadilla Pharmaceuticals Limited, India 1117 Norfen 400mg Tablets Norfloxacin 400mg POM Tablet Uncoated 113/031 Cadilla Pharmaceuticals Limited, India Sulphamethoxazole POM Tablet Uncoated 113/032 Cadilla Pharmaceuticals Limited, India Cadiprim 480mg Tablets 400mg + Trimethoprim 1118 80mg Trimethoprim 40mg + POM Suspension for 113/033 Cadilla Pharmaceuticals Limited, India Cadiprim 240 Mg Suspension Sulphamethoxazole Oral Use 1119 200mg Albendazole 200mg, per POM Suspension 113/035 Cadilla Pharmaceuticals Limited, India Wormin-A Suspension 1120 5ml 1121 Cadiphen 4mg Tablets Chlorpheniramine 4mg P Tablet Uncoated 113/037 Cadilla Pharmaceuticals Limited, India 1122 Decon Nasal Drops Xylometazoline 0.1%w/v POM Nasal drops 113/039 Cadilla Pharmaceuticals Limited, India 1123 Decon Pediatric Nasal Drops Xylometazoline 0.05% POM Nasal drops 113/040 Cadilla Pharmaceuticals Limited, India 1124 Ibunate 400 Tablets Ibuprofen 400mg P Tablet Uncoated 113/041 Cadilla Pharmaceuticals Limited, India 1125 Nilide 100mg Tablets Nimesulide 100mg POM Tablet Uncoated 113/042 Cadilla Pharmaceuticals Limited, India Neomycin Sulphate POM Ear/Eye Drops 113/043 Cadilla Pharmaceuticals Limited, India 0.35%w/v + Dexasone Eye/Ear Drops Dexamethasone Sodium 1126 Phosphate 0.1%w/v Paracetamol 500mg + P Tablet Uncoated 113/044 Cadilla Pharmaceuticals Limited, India Trigan-D Tablets 1127 Dicyclomine 20mg Ascorbic Acid 150mg + POM Capsule oral 113/045 Cadilla Pharmaceuticals Limited, India Vitamin E 25mg EC-350 Capsules +Selenium 75mg +Alpha 1128 Lipoic Acid 100mg

Page 59 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Isoniazid 150mg + POM Tablet Uncoated 113/046 Cadilla Pharmaceuticals Limited, India Mycocox Tablets 1129 Rifampicin 150mg 1130 Scat 200mg Tablets Sparfloxacin 200mg POM Tablet Uncoated 113/047 Cadilla Pharmaceuticals Limited, India Domperidone 5mg, per POM Solution for Oral 113/049 Cadilla Pharmaceuticals Limited, India Domperon Suspension 1131 5ml Use 1132 Herbisept Herbal Cream Herbal extract 30mg P Cream Topical 113/050 Cadilla Pharmaceuticals Limited, India Cefotaxime 250mg POM Powder for 113/051 Cadilla Pharmaceuticals Limited, India Oritaxim 250mg Injection 1133 Injection Ceftriaxone 1g POM Powder for 113/052 Cadilla Pharmaceuticals Limited, India Axone 1000 Injection 1134 Injection Azithromycin 200mg, per POM Syrup 113/053 Cadilla Pharmaceuticals Limited, India Zycin Dry Syrup 1135 5ml 1136 Zycin Capsules Azithromycin 250mg POM Capsule oral 113/054 Cadilla Pharmaceuticals Limited, India 1137 Zycin DT Tablets Azithromycin 100mg POM Tablet Uncoated 113/055 Cadilla Pharmaceuticals Limited, India 1138 Lorcap Eye/Ear Drops Pilocarpine 20mg POM Ear/Eye Drops 113/056 Cadilla Pharmaceuticals Limited, India Polyvinyl alcohol 14mg, P Eye Drops 113/057 Cadilla Pharmaceuticals Limited, India PVA Tears Eye Drops 1139 per 10ml 1140 Gentamycin Eye Drops Gentamicin 3mcg, per ml POM Ear/Eye Drops 113/058 Cadilla Pharmaceuticals Limited, India Polymyxin B 10000iu + POM Ear/Eye Drops 113/059 Cadilla Pharmaceuticals Limited, India Trimethroprim 1mg, per Cadiprim Eye/Ear Drops ml + Polyvinyl Alcohol 1141 1%v/v 1142 Cadilac Eye Drops Ketoralac 5mcg, per ml POM Ear/Eye Drops 113/060 Cadilla Pharmaceuticals Limited, India Sanvic Opthalmic Solutions Eye Hydroxypropylmethyl POM Eye Drops 113/061 Cadilla Pharmaceuticals Limited, India 1143 Drops. cellulose 2%w/v Cefuroxime 750mg POM Powder for 113/062 Cadilla Pharmaceuticals Limited, India Cefogen 750 Injection 1144 Injection Betamethasone 1mg, per POM Eye Drops 113/063 Cadilla Pharmaceuticals Limited, India Sanbeta Eye Drops 1145 ml 1146 Mycobutol 800mg Tablets Ethambutol 800mg POM Tablet Uncoated 113/065 Cadilla Pharmaceuticals Limited, India Naphazoline POM Eye Drops 113/066 Cadilla Pharmaceuticals Limited, India Decon Eye Drops 1147 Hydrochloride 0.01%w/w Benzalkonuim Chloride POM Eye Drops 113/067 Cadilla Pharmaceuticals Limited, India 0.01%w/v + Tmide Plus Eye Drops Phenylephrine 5%w/v + 1148 Tropicamide 0.8%w/v Rabeprazole 20mg, per POM Solution for 113/068 Cadilla Pharmaceuticals Limited, India Rabeloc Injection 1149 ml Injection 1150 Rabeloc 10 Tablets Rabeprazole 10mg POM Tablet Uncoated 113/069 Cadilla Pharmaceuticals Limited, India

Page 60 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 1151 Rabeloc-20 Tablets Rabeprazole 20mg POM Tablet Uncoated 113/070 Cadilla Pharmaceuticals Limited, India 1152 Scat Eye/Ear Drops Sparfloxacin 0.3% POM Ear/Eye Drops 113/071 Cadilla Pharmaceuticals Limited, India Aluminium Hydroxide + GS Suspension for 113/072 Cadilla Pharmaceuticals Limited, India Locid Suspension Magnesium Trisilscate Oral Use 1153 474mg Cefpodoxime 50mg, per POM Suspension for 113/073 Cadilla Pharmaceuticals Limited, India Tambac 50 Suspension 1154 5ml Oral Use 1155 Nodon 5 Tablets Nebivolol 5mg POM Tablet Uncoated 113/074 Cadilla Pharmaceuticals Limited, India 1156 Piozulin 15 Tablets Pioglitazone 15mg POM Tablet Uncoated 113/075 Cadilla Pharmaceuticals Limited, India 1157 Piozulin 30 Tablets Pioglitazone 30mg POM Tablet Uncoated 113/076 Cadilla Pharmaceuticals Limited, India Chlorpheniramine 80mg P Solution for Oral 113/077 Cadilla Pharmaceuticals Limited, India + Ammonium 100mg + Use Cadiphen Expectorant Sodium Citrate 44mg + 1158 Menthol 0.8mg Folic Acid 1.5mg + P Capsule oral 113/078 Cadilla Pharmaceuticals Limited, India Ferrous Fumarate 200mg Haem-Up Gems Capsules + Cupric Sulfate 2.5mg + Manganese Sulfate 1159 2.5mg Folic Acid 0.5mg + Ferric P Solution for Oral 113/079 Cadilla Pharmaceuticals Limited, India Ammonium Citrate Use 160mg + Cupric Sulphate Haem-Up Syrup 30 mcg + Manganese Sulphate 30 mcg 1160 Ranitidine 25mg POM Powder for 113/080 Cadilla Pharmaceuticals Limited, India Aciloc Injection 1161 Injection 1162 Amtba 500 Tablets Tinidazole 500mg POM Tablet Uncoated 113/081 Cadilla Pharmaceuticals Limited, India 1163 Calnif Retard Nifedipine 20mg POM Tablet Uncoated 113/082 Cadilla Pharmaceuticals Limited, India Cephalexin 125 mg, per 5 POM Syrup 113/083 Cadilla Pharmaceuticals Limited, India Cefamor Dry Syrup 1164 ml Idochlorohydroxyquinolon POM Ointment topical 113/084 Cadilla Pharmaceuticals Limited, India e 3%w/w + Dexaquin Ointment Dexamethasone 1165 0.05%w/w 1166 Domperon Tablets Domperidone 10mg POM Tablet Uncoated 113/085 Cadilla Pharmaceuticals Limited, India 1167 Envas 10mg Tablets Enalapril 10mg POM Tablet Uncoated 113/086 Cadilla Pharmaceuticals Limited, India 1168 Envas 5mg Tablets Enalapril 5mg POM Tablet Uncoated 113/087 Cadilla Pharmaceuticals Limited, India

Page 61 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Ocupress 2.5mg/ml Ophthalmic Timolol 2.5mg, per ml POM Eye Drops 113/088 Cadilla Pharmaceuticals Limited, India 1169 Solution Ocupress 5mg/ml Ophthalmic Timolol 5mg, per ml POM Eye Drops 113/089 Cadilla Pharmaceuticals Limited, India 1170 Solution Triamcinolone 40mg POM Solution for 113/090 Cadilla Pharmaceuticals Limited, India Tricort Injection 1171 Injection 1172 Wormin 500mg Tablets Mebendazole 500mg P Tablet Uncoated 113/091 Cadilla Pharmaceuticals Limited, India 1173 Allerstat 180 Tablets Fexofenadine 180mg P Tablet Uncoated 113/092 Cadilla Pharmaceuticals Limited, India 1174 Allerstat 120 Tablets Fexofenadine 120mg P Tablet Uncoated 113/093 Cadilla Pharmaceuticals Limited, India 1175 Cupid 50 Tablets Sildenafil 50mg POM Tablet Film coated 113/094 Cadilla Pharmaceuticals Limited, India Simvastatin 20mg + POM Capsule oral 113/095 Cadilla Pharmaceuticals Limited, India Ramipril 5mg + Atenolol Polycap Capsules 50mg + Hydrochlorothiazide 1176 12.5mg 1177 Cadigrel Tablets Clopidogrel 75mg POM Tablet Uncoated 113/096 Cadilla Pharmaceuticals Limited, India Ondansetron POM Solution for 113/097 Cadilla Pharmaceuticals Limited, India Onsett 2ml Injection hydrochloride 2mg, per Injection 1178 ml Ondansetron POM Tablet Uncoated 113/098 Cadilla Pharmaceuticals Limited, India Onsett 4 Tablets 1179 Hydrochloride 4mg Ondansetron POM Tablet Uncoated 113/099 Cadilla Pharmaceuticals Limited, India Onsett 8 Tablets 1180 Hydrochloride 8mg 1181 Teli -80 Tablets Telmisartan 80mg POM Tablet Uncoated 113/100 Cadilla Pharmaceuticals Limited, India 1182 Teli-40 Tablets Telmisartan 40mg POM Tablet Uncoated 113/101 Cadilla Pharmaceuticals Limited, India Telmisartan 40mg + POM Tablet Uncoated 113/102 Cadilla Pharmaceuticals Limited, India Teli -H Tablets Hydrochlorothiazide 1183 12.5mg Atorvastalin Calcium POM Tablet Uncoated 113/103 Cadilla Pharmaceuticals Limited, India Caditor 20 Tablets 1184 20mg Cefpodoxime Proxetil POM Tablet Uncoated 113/104 Cadilla Pharmaceuticals Limited, India Tambac 100 Tablets 1185 100mg Cefpodoxime Proxetil POM Tablet Uncoated 113/105 Cadilla Pharmaceuticals Limited, India Tambac 200 Tablets 1186 200mg Ketorolac Tromethamine POM Solution for 113/106 Cadilla Pharmaceuticals Limited, India Dolac 30 Injection 1187 USP 30mg Injection Lactitol Monohydrate POM Solution for Oral 113/107 Cadilla Pharmaceuticals Limited, India Procticad 1188 10gm, per 15ml Use 1189 Zealargy Tablets Rupatadine 10mg P Tablet Uncoated 113/109 Cadilla Pharmaceuticals Limited, India

Page 62 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 1190 Camedol Tablets Paracetamol 500mg GS Tablet Uncoated 271/001 Cameo Healthcare(L) Pvt Ltd, India 1191 Cafem- 200 Tablets Ibuprofen 200mg P Tablet Uncoated 271/002 Cameo Healthcare(L) Pvt Ltd, India 1192 Camelox-250 Capsules Cloxacillin BP 250mg POM Capsule oral 271/003 Cameo Healthcare(L) Pvt Ltd, India Cloxacillin BP 125mg, POM Powder for Oral 271/004 Cameo Healthcare(L) Pvt Ltd, India Camelox-125 Oral Suspension 1193 per 5ml Suspension 1194 Camecillin-250 Capsules Ampicillin BP 250mg POM Capsule oral 271/005 Cameo Healthcare(L) Pvt Ltd, India Ampicillin BP 125mg, per POM Powder for Oral 271/006 Cameo Healthcare(L) Pvt Ltd, India Camecillin-125 Oral Suspension 1195 5ml Suspension 1196 Camoxy-250mg Capsule Amoxicillin 250mg POM Capsule oral 271/007 Cameo Healthcare(L) Pvt Ltd, India Amoxicillin BP 125mg, POM Powder for Oral 271/008 Cameo Healthcare(L) Pvt Ltd, India Camoxy-125 Oral Suspension 1197 per 5ml Suspension 1198 Indocame Capsules Indomethacin 25mg P Capsule oral 271/009 Cameo Healthcare(L) Pvt Ltd, India Co-trimoxazole 240mg POM Powder for Oral 271/010 Cameo Healthcare(L) Pvt Ltd, India Cotricam 240 Oral Suspension 1199 Suspension Pyridoxine Hydrochloride P Tablet Uncoated 271/011 Cameo Healthcare(L) Pvt Ltd, India Vitacam B6 Tablets 1200 50mg 1201 Camvit-B Tablets Vitamin B complex P Tablet Uncoated 271/012 Cameo Healthcare(L) Pvt Ltd, India 1202 Cametrin Tablets Pyrantel Pamoate POM Tablet Uncoated 271/013 Cameo Healthcare(L) Pvt Ltd, India Paracetamol + P Syrup 271/014 Cameo Healthcare(L) Pvt Ltd, India Cold Off Junior Syrup 1203 Chlopheniramine Paracetamol BP + P Tablet Uncoated 271/015 Cameo Healthcare(L) Pvt Ltd, India Camflam Tablets 1204 Ibuprofen BP Diclofenac Sodium 50mg P Tablet Uncoated 271/016 Cameo Healthcare(L) Pvt Ltd, India Fenacam 50 Tablets 1205 Sulfadoxine BP + POM Tablet Uncoated 271/017 Cameo Healthcare(L) Pvt Ltd, India Malsycam Tablets Pyrimethamine BP 1206 525MG Nalidixic Acid 500mg POM Suspension for 271/018 Cameo Healthcare(L) Pvt Ltd, India Dixicam 500 Tablets 1207 Oral Use Trimethoprim 80 + POM Tablet Uncoated 271/019 Cameo Healthcare(L) Pvt Ltd, India Cotricam Tablets Sulphamethoxazole 1208 400mg Metronidazole BP 200mg POM Tablet Uncoated 271/020 Cameo Healthcare(L) Pvt Ltd, India Metrocam Tablets 1209 1210 Flucocam 200 Capsules Fluconazole 200mg POM Capsule oral 271/022 Cameo Healthcare(L) Pvt Ltd, India Ascorbic Acid BP 100mg GS Tablet Uncoated 271/023 Cameo Healthcare(L) Pvt Ltd, India Vitacam C Tablets 1211 1212 Maxivit Tablets Multivitamin GS Tablet Uncoated 271/024 Cameo Healthcare(L) Pvt Ltd, India 1213 Amocillin 250mg Capsules Amoxicillin 250mg POM Capsule oral 024/001 Caps (Private) Ltd, Zimbabwe

Page 63 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 1214 Amocillin 500mg Capsules Amoxicillin 500mg POM Capsule oral 024/002 Caps (Private) Ltd, Zimbabwe Amocillin 125mg/5ml Amoxicillin 125mg, per POM Suspension for 024/003 Caps (Private) Ltd, Zimbabwe 1215 Suspension 5ml Oral Use Amocillin 250mg/5ml Amoxicillin 250mg, per POM Suspension for 024/004 Caps (Private) Ltd, Zimbabwe 1216 Suspension 5ml Oral Use Benzyl Penicillin 1 MU POM Powder for 024/005 Caps (Private) Ltd, Zimbabwe Benzylpencillin 1 Mega Injection 1217 Injection Benzyl Penicillin 5 MU POM Powder for 024/006 Caps (Private) Ltd, Zimbabwe Benzylpencillin 5 Mega Injection 1218 Injection 1219 Capcycline 250mg Capsules Cloxacillin 250mg POM Capsule oral 024/007 Caps (Private) Ltd, Zimbabwe 1220 Chlornicol 250mg Capsules Chloramphenicol 250mg POM Capsule oral 024/008 Caps (Private) Ltd, Zimbabwe Chloramphenicol 1g POM Powder for 024/009 Caps (Private) Ltd, Zimbabwe Chlornicol 1g Injection 1221 Injection Chlornicol 125mg/5ml Chloramphenicol 125mg, POM Suspension for 024/010 Caps (Private) Ltd, Zimbabwe 1222 Suspension per 5ml Oral Use Trimethoprim 40mg + POM Tablet Uncoated 024/014 Caps (Private) Ltd, Zimbabwe Co-Trimoxazole Peadiatric Sulphamethoxazole Tablets 1223 200mg Trimethoprim + POM Suspension for 024/015 Caps (Private) Ltd, Zimbabwe Co-Trimoxazole Suspension 1224 Sulphamethoxazole Oral Use Trimethoprim 80mg + POM Tablet Uncoated 024/016 Caps (Private) Ltd, Zimbabwe Co-Trimoxazole Tablets Sulphamethoxazole 1225 400mg Diazepam 10mg, per ml POM Solution for 024/017 Caps (Private) Ltd, Zimbabwe Dizam Injection 1226 Injection 1227 Dizam 2mg Tablets Diazepam 2mg POM Tablet Uncoated 024/018 Caps (Private) Ltd, Zimbabwe 1228 Dizam 5mg Tablets Diazepam 5mg POM Tablet Uncoated 024/019 Caps (Private) Ltd, Zimbabwe Oflaxacin + Aflaxacin POM Capsule oral 024/020 Caps (Private) Ltd, Zimbabwe Dolex 200mg Capsules 1229 200mg Oflaxacin + Aflaxacin POM Capsule oral 024/021 Caps (Private) Ltd, Zimbabwe Dolex 400mg Capsules 1230 400mg 1231 Doxyclin Capsules Doxycycline 100mg POM Capsule oral 024/022 Caps (Private) Ltd, Zimbabwe 1232 Equemote 50mg Capsules Sulpiride 50mg POM Capsule oral 024/023 Caps (Private) Ltd, Zimbabwe 1233 Famicillin 250mg Capsules Ampicillin 250mg POM Capsule oral 024/024 Caps (Private) Ltd, Zimbabwe 1234 Famicillin 500mg Capsules Ampicillin 500mg POM Capsule oral 024/025 Caps (Private) Ltd, Zimbabwe Famicillin 125mg/5ml Ampicillin 125mg, per POM Suspension for 024/026 Caps (Private) Ltd, Zimbabwe 1235 Suspension 5ml Oral Use Ampicillin POM Powder for 024/027 Caps (Private) Ltd, Zimbabwe Famicillin Injection 1236 Injection

Page 64 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Famicillin 250mg/5ml Ampicillin 250mg, per POM Suspension for 024/028 Caps (Private) Ltd, Zimbabwe 1237 Suspension 5ml Oral Use 1238 Ferous Sulphate Tablets Ferrous Sulphate 200mg P Tablet Uncoated 024/029 Caps (Private) Ltd, Zimbabwe Hydrochlorothiazide POM Tablet Uncoated 024/030 Caps (Private) Ltd, Zimbabwe Hydrochlorothiazide Tablets 1239 25mg Hydrochlorothiazide POM Tablet Uncoated 024/031 Caps (Private) Ltd, Zimbabwe Hydrochlorothiazide Tablets 1240 50mg 1241 Hypotens Tablets Trifluoperazine 250mg POM Tablet Uncoated 024/032 Caps (Private) Ltd, Zimbabwe Kanamycin 250mg POM Powder for 024/033 Caps (Private) Ltd, Zimbabwe Kanamycin Injection 1242 Injection Pyrimethamine + P Tablet Uncoated 024/034 Caps (Private) Ltd, Zimbabwe Malasone Tablets 1243 Dapsone 1244 Methocid 25mg Capsules Indomethacin 25mg P Capsule oral 024/035 Caps (Private) Ltd, Zimbabwe 1245 Methocid 50mg Caspules Indomethacin 50mg P Capsule oral 024/036 Caps (Private) Ltd, Zimbabwe 1246 Methocid Suppositories Indomethacin 100mg POM Suppository 024/037 Caps (Private) Ltd, Zimbabwe Metronidazole 200mg, POM Suspension for 024/038 Caps (Private) Ltd, Zimbabwe Metronidazole Suspension 1247 per 5mls Oral Use 1248 Metronidazole 200mg Tablets Metronidazole 200mg POM Tablet Uncoated 024/039 Caps (Private) Ltd, Zimbabwe 1249 Metronidazole 400 Mg Tablets Metronidazole 400mg POM Tablet Uncoated 024/040 Caps (Private) Ltd, Zimbabwe Trimethoprim + POM Tablet Uncoated 024/041 Caps (Private) Ltd, Zimbabwe Mezenol DS Tablets 1250 Sulphamethoxazole Paracetamol 120mg, per GS Syrup 024/042 Caps (Private) Ltd, Zimbabwe Paracetamol Syrup 1251 5ml 1252 Paracetamol Tablets Paracetamol 500mg GS Tablet Uncoated 024/043 Caps (Private) Ltd, Zimbabwe Cyanocobalamine 1mg, POM Solution for 024/044 Caps (Private) Ltd, Zimbabwe Parecon Forte Injection 1253 per ml Injection Procaine Benzyl Penicillin POM Solution for 024/045 Caps (Private) Ltd, Zimbabwe Procillin Injection 1254 300mg/ml Injection 1255 Purinol Tablets Allopurinol 100mg POM Tablet Uncoated 024/046 Caps (Private) Ltd, Zimbabwe 1256 Rexigen 10mg Tablets Propranalol 10mg POM Tablet Uncoated 024/047 Caps (Private) Ltd, Zimbabwe 1257 Rexigen 40mg Tablets Propranalol 40mg POM Tablet Uncoated 024/048 Caps (Private) Ltd, Zimbabwe 1258 Rexigen 80mg Tablets Propranalol 80mg POM Tablet Uncoated 024/049 Caps (Private) Ltd, Zimbabwe 1259 Rexigen 160mg Tablets Propranalol 160mg POM Tablet Uncoated 024/050 Caps (Private) Ltd, Zimbabwe Streptosol 5g, per 15ml POM Solution for 024/051 Caps (Private) Ltd, Zimbabwe Streptosol 5g/15ml Injection 1260 injection Injection Tetracycline POM Eye Ointment 024/052 Caps (Private) Ltd, Zimbabwe Tetracycline Eye Ointment Hydrochloride 30mg, per 1261 g

Page 65 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Benzathine Penicillin POM Tablet Uncoated 024/053 Caps (Private) Ltd, Zimbabwe Ultracillin LA Injection 1262 2.4MU Amiloride Hydrochloride POM Tablet Uncoated 024/054 Caps (Private) Ltd, Zimbabwe 5mg + Urazide Tablets Hydrochlorothiazide 1263 50mg Water for injection POM Solution for 024/055 Caps (Private) Ltd, Zimbabwe Water For Injection 1264 Injection Lignocaine Hydrochloride POM Solution for 024/056 Caps (Private) Ltd, Zimbabwe Xylonor Injection 2% + Norepinephrine Injection 1265 1266 Prednisolone Tablets Prednisolone 5mg POM Tablet Uncoated 024/057 Caps (Private) Ltd, Zimbabwe Dextromethorphan P Syrup 024/058 Caps (Private) Ltd, Zimbabwe Hydrobromide 9mg + Histalix D Syrup Diphenylhydramine 10mg+ Ammonium 1267 Chloride 90mg 1268 Phenobarbitone Tablets Phenobarbitone 30mg POM Tablet Uncoated 024/059 Caps (Private) Ltd, Zimbabwe 1269 Allergon Cream Mepyramine 400mg P Cream Topical 024/060 Caps (Private) Ltd, Zimbabwe Paracetamol 500mg + P Tablet Uncoated 024/061 Caps (Private) Ltd, Zimbabwe Flumel Tablets Chlorpheniramine 2mg + 1270 Phenylephrine 10mg Paracetamol 120mg + P Syrup 024/062 Caps (Private) Ltd, Zimbabwe Chlorpheniramine 2mg + 4C's Cold Syrup Phenylephrine 2.5mg + Dextromethorphan 0.5mg 1271 per 5mls Codeine Phosphate 9mg P Syrup 024/063 Caps (Private) Ltd, Zimbabwe + Ammonium Chloride Histalix Syrup 90mg + Diphenhydramine 10mg, 1272 per 5ml Cefuroxime Axetil POM Powder for Oral 343/001 CCL Pharmaceuticals (PVT) Ltd, India Kefrox Oral Suspension 1273 125mg, per 5ml Suspension Cefuroxime Axetil 500mg POM Tablet Uncoated 343/002 CCL Pharmaceuticals (PVT) Ltd, India Kefrox Tablets 1274 Leucovorin 15mg, per POM Solution for 073/001MT Celon Laboratories Limited Lucal 15 Injection 1275 3ml Injection

Page 66 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Fluorouracil 500mg, per POM Powder for 073/002MT Celon Laboratories Limited 5 Flucel 500 Injection 1276 10ml Injection L-Asparaginase 10,000 POM Powder for 073/003MT Celon Laboratories Limited Celginase 1000 Injection 1277 IU Injection Vitamin A USP 1000 IU + GS Syrup 061/001 Centaur Pharmaceuticals (Pvt Limited, India Vitamin B1 BP 1.5 mg + Riboflavine Sodium Phosphate BP 1.5 mg + Centavit Syrup Nicotinamide BP 10 mg + Vitamin B12 USP 2.5 mcg + Vitamin C BP 40 mg+ Vitamin D3 BP 200 1278 IU, per 5ml Soya Protein Hydrolysate P Syrup 061/002 Centaur Pharmaceuticals (Pvt Limited, India 1.0g + Iron Choline Citrate 15mg+ Cyanocobalamine 5mcg + Thiamine Nitrate 2.5mg + Riboflavin 2.5mg Protobex Syrup + Pyridoxine Hydrochloride 1.5mg + Niacinamide 25mg + Panthenol 3mg + Zinc Sulphate eq to zinc 1279 7.5mg Dextromethorphan 10mg P Solution for Oral 061/003 Centaur Pharmaceuticals (Pvt Limited, India Sinarest Linctus + Chlopheniramine 2mg Use 1280 + Menthol 1.5mg Terbutalin Sulphate P Syrup 061/004 Centaur Pharmaceuticals (Pvt Limited, India 2.5mg + Ambroxol Kofarest Syrup Hydrochloride 30mg + Guaiphenesin 100mg + 1281 Menthol 5mg, per 10ml Diclofenac Sodium 1mg + POM Solution for Topical 061/005 Centaur Pharmaceuticals (Pvt Limited, India Diclogenta Eye Drops Gentamycin Sulphate Use 1282 3mg Acyclovir 3% POM Eye Ointment 061/006 Centaur Pharmaceuticals (Pvt Limited, India Eyevir Eye Ointment 1283

Page 67 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Diclofenac Sodium USP POM Eye Drops 061/007 Centaur Pharmaceuticals (Pvt Limited, India I-Gesic Eye Drops 1284 0.1%w/v Dextromethorphan 5mg + P Lozenges 061/008 Centaur Pharmaceuticals (Pvt Limited, India Kofarest Lozenges Cetylpyridium 1.3mg + 1285 Menthol 5.2mg Levofloxacin 0.5% POM Ear/Eye Drops 061/009 Centaur Pharmaceuticals (Pvt Limited, India Leeflox Eye/Ear Drops 1286 Phenylephrine POM Solution for Topical 061/010 Centaur Pharmaceuticals (Pvt Limited, India Hydrochloride 0.12% w/v Use + Naphazoline Hydrochloride 0.05%w/v Ocurest - AH Eye Drops + Chlorpheniramine Maleate 0.1% w/v + Menthol 0.0005% w/v + 1287 Camphor 0.01%w/v Tobramycin Sulphate POM Eye Drops 061/011 Centaur Pharmaceuticals (Pvt Limited, India 0.3% + Dexamethasone Ocutob D Eye Drops 0.1% + Benzalkonium 1288 Chloride 0.01% Polyvinyl Alcohol 1.4% + POM Eye Drops 061/012 Centaur Pharmaceuticals (Pvt Limited, India Povidone 0.6% + Ocuwet Eye Drops Benzalkonium Chloride 1289 0.01% Chloramphenicol POM Solution for Topical 061/013 Centaur Pharmaceuticals (Pvt Limited, India Opticol Eye Drops 1290 0.5%w/v Use Potassium Iodide POM Eye Drops 061/014 Centaur Pharmaceuticals (Pvt Limited, India 3.3%w/v + Sodium Catarest Eye Drops Chloride 0.83%w/v + Calcium Chloride 1291 1.0%w/v Silymarin 70 mg + P Capsule oral 061/015 Centaur Pharmaceuticals (Pvt Limited, India Thiamine Mononitrate 5 mg + Riboflavin 5 mg + Pyridoxine Hydrochloride Livosil-B Capsules 1.5 mg + Niacinamide 25 mg +Calcium Panthothenate 7.5 mg +Vitamin B12 5 mcg 1292

Page 68 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 1293 Manoll Syrup Herbal Extracts P Syrup 370/001L Charak Pharma Pvt Ltd. 1294 Ojus Syrup Herbal Extracts P Syrup 370/002L Charak Pharma Pvt Ltd. 1295 Addyzoa Tablets Herbal Extracts P Tablet Uncoated 370/003L Charak Pharma Pvt Ltd. 1296 M2 Tone Tablets Herbal Extracts P Tablet Uncoated 370/004L Charak Pharma Pvt Ltd. 1297 Hyponidd Tablets Herbal Extracts P Tablet Uncoated 370/005L Charak Pharma Pvt Ltd. 1298 Arthrelia Tablets Herbal Extracts P Tablet Uncoated 370/006L Charak Pharma Pvt Ltd. 1299 Vigomax Forte Tablets Herbal Extracts P Tablet Film coated 370/007L Charak Pharma Pvt Ltd. 1300 LO.Ivomyn Tablets Herbal Extracts P Tablet Uncoated 370/008L Charak Pharma Pvt Ltd. 1301 Pilief Tablets Herbal Extracts P Tablet Uncoated 370/009L Charak Pharma Pvt Ltd. 1302 Richelth Tablets Herbal Extracts P Tablet Uncoated 370/010L Charak Pharma Pvt Ltd. 1303 Kofol SF Syrup Herbal Extracts P Tablet Uncoated 370/011L Charak Pharma Pvt Ltd. 1304 Paedritone Syrup Herbal Extracts P Syrup 370/012L Charak Pharma Pvt Ltd. 1305 Athrella Ointment Herbal Extracts P Ointment topical 370/014L Charak Pharma Pvt Ltd. 1306 Pilief Ointment Herbal Extracts P Ointment topical 370/015L Charak Pharma Pvt Ltd. Vitamin A acetate 1500µg P Tablet Film coated 402/001 Chempure Pty Ltd Vitamin A 1500µg Tablets 1307 Iron BisGlycinate Chelate P Capsule oral 402/002 Chempure Pty Ltd 10mg + Activated Folate Iron Plus Capsules 400mcg + Vtamin B12 100mcg 1308 Chromium Polynicotinate Chromium Polynicotinate P Tablet Uncoated 402/003L Chempure Pty Ltd 1309 Tablets 200mcg Mixed Tocotrienols + P Capsule oral 402/004L Chempure Pty Ltd Full Spectrum Vitamin E 400mg Mixed Tocopherols Capsules 1310 400mg 1311 Ubiquinol CO-Q10 Capsules Ubiquinol 50mg P Capsule oral 402/005L Chempure Pty Ltd Calcium Glycinate 750mg P Tablet Film coated 402/006L Chempure Pty Ltd Calcium Glycinate with Vitamin + Vitamin D3 200IU + D3 and Boron Tablets 1312 Boron 500µg 500mg + 110mg + 60mg P Capsule oral 402/007L Chempure Pty Ltd Krill Oil Omega-3 Capsules 1313 Magnesium Glycinate P Tablet Film coated 402/008L Chempure Pty Ltd Magnesium Glycinate Tablets 1110mg + Boron 500mcg 1314 Irvingia extract 100mg + P Capsule oral 402/009L Chempure Pty Ltd Irvingia Plus Fat Burner Berberine 200mg + Kelp Capsules extract 17mg + Zinc 5mg 1315 + Panax

Page 69 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER L-arginine Hydrochloride P Capsule oral 402/010L Chempure Pty Ltd Libido & Performance Enhancer 4425mg + Tongkat ali for Men Capsules 37.5mg + Tribulus 1316 terrestris 125mg + Pana Vitamin C-water soluble GS Capsule oral 402/011L Chempure Pty Ltd Double Vitamin C Capsules 233mg + Vitamin C-fat 1317 soluble 100mg Methyl-Sulfonyl-Methane (MSM) Methylsulfonylmethane Pharmacy Capsule oral 402/012L Chempure Pty Ltd 1318 Capsules 700mg Medicine Calmlite with Relora® and Relora 250mg + P Capsule oral 402/013L Chempure Pty Ltd 1319 Theanine Capsules Theanine 125mg Folic Acid 500mcg Pharmacy Tablet Uncoated 402/014L Chempure Pty Ltd Folic Acid Natural Folate Tablets 1320 Medicine Povidone-Iodine 5 % w/w P Ointment topical 381/001 Cian Health Care Pvt Ltd. Iodin Plus Ointment 1321 Stogel Forte Tablets Methyl Sulfonyl Methane P Tablet Uncoated 381/002L Cian Health Care Pvt Ltd. 350mg + Glucosamine Sulfate 150mg +Tricalcium Phosphate 150mg + Guggul 100mg + Bromelain 60mg + Chondroitin Sulfate 50mg + Ashwagandha 40mg + Hadjod 40mg + Rutin 25mg + Boswellia Serrata Gum Powder Extract 25mg + Lecithin Granular 15mg + Cat’s Claw Bark Powder 15mg + Hyaluronic Acid 7.5mg+Boron Aspartate 1322 3mg Lycogel Extra Capsules Lycopene 10mg + P Capsule oral 381/004L Cian Health Care Pvt Ltd. Multivitamin + Multi mineral + Ginseng Extract Powder 30mg + Grape Seed Extract 10mg + Green Tea 1323 Extract 10mg

Page 70 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER G - Biloba Tablets Multivitamin + P Tablet Uncoated 381/003L Cian Health Care Pvt Ltd. Multimineral + Beta- Carotene 400mcg + Ginseng Extract Powder 200mg + Ginkgo Biloba 1324 125mg 1325 Zidovir 100 Capsules Zidovudine 100mg POM Capsule oral 099/001 Cipla Limited, India 1326 Ciplox 250mg Tablets Ciprofloxacin 250mg POM Tablet Uncoated 099/002 Cipla Limited, India 1327 Ciplox 500mg Tablets Ciprofloxacin 500mg POM Tablet Uncoated 099/003 Cipla Limited, India 1328 Ciplox Eye Ointment Ciprofloxacin 0.3%w/w POM Eye Ointment 099/004 Cipla Limited, India 1329 Ciplox Eye/Ear Drops Ciprofloxacin 0.3%w/v POM Ear/Eye Drops 099/005 Cipla Limited, India 1330 Profenac Eye Drops Diclofenac 0.1%w/v POM Eye Drops 099/006 Cipla Limited, India 1331 Fungicip Cream Clotrimazole 1%w/v POM Cream Topical 099/007 Cipla Limited, India 1332 Fungicip - 100 Tablets Clotrimazole 100mg POM Tablet Vaginal 099/008 Cipla Limited, India 1333 Fungicip 200 Tablets Clotrimazole 200mg POM Tablet Vaginal 099/009 Cipla Limited, India Stavudine 30mg + POM Tablet Uncoated 099/010 Cipla Limited, India Triomune 30 Tablets Nevirapine 200mg + 1334 Lamivudine 150mg Lamivudine 150mg + POM Tablet Uncoated 099/011 Cipla Limited, India Lamivir-S 30 Tablets 1335 Stavudine 30mg Lamivudine 150mg + POM Tablet Uncoated 099/012 Cipla Limited, India Lamivir-S 40 Tablets 1336 Stavudine 40mg 1337 Efivir -200 Tablets Efavirenz 200mg POM Tablet Uncoated 099/013 Cipla Limited, India 1338 Nelvir Tablets Nelfinavir 250mg POM Tablet Uncoated 099/014 Cipla Limited, India 1339 Lamivir Tablets Lamivudine 150mg POM Tablet Uncoated 099/015 Cipla Limited, India Zidovudine 50mg, per POM Solution for Oral 099/016 Cipla Limited, India Zidovir Solution 1340 5ml Use Nevirapine 50mg, per POM Suspension for 099/018 Cipla Limited, India Nevimune Oral Suspension 1341 5ml Oral Use 1342 Indivan 200mg Capsules Indinavir 200mg POM Capsule oral 099/019 Cipla Limited, India Zidovudine 300mg + POM Tablet Uncoated 099/020 Cipla Limited, India Duovir N Tablets Lamivudine 150mg + 1343 Nevirapine 200mg 1344 Stavir 30 Tablets Stavudine 30mg POM Tablet Uncoated 099/021 Cipla Limited, India 1345 Stavir 40 Tablets Stavudine 40mg POM Tablet Uncoated 099/022 Cipla Limited, India Lamivudine 50mg, per POM Solution for Oral 099/023 Cipla Limited, India Lamivir 50mg/ml Oral Solution 1346 5ml Use 1347 Divir 100 Tablets Didanosine 100mg POM Tablet Uncoated 099/024 Cipla Limited, India

Page 71 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Spectinomycin 2g POM Powder for 099/025 Cipla Limited, India Spectin Injection 1348 Injection 1349 Tadacip 10 Tablets Tadalafil 10mg POM Tablet Uncoated 099/026 Cipla Limited, India 1350 Lovacard 20 Tablets Levostatin 20mg POM Tablet Uncoated 099/027 Cipla Limited, India 1351 Cipril 5 Tablets Lisinopril 5mg POM Tablet Uncoated 099/028 Cipla Limited, India Cefotaxime 1000mg POM Powder for 099/029 Cipla Limited, India Novatax 1000 Injection 1352 Injection 1353 Simcard 10 Tablets Simvastatin 10mg POM Tablet Uncoated 099/030 Cipla Limited, India 1354 Acivir 200 Dispersible Tablets Acyclovir 200mg POM Tablet Uncoated 099/032 Cipla Limited, India Salbutamol 100mcg POM Solution for 099/033 Cipla Limited, India Asthalin 100mcg/Spray Inhaler 1355 Inhalation Artemether 40mg POM Solution for 099/034 Cipla Limited, India Falcithar 40 Injection 1356 Injection Artemether 80mg POM Solution for 099/035 Cipla Limited, India Falcithar 80 Injection 1357 Injection 1358 Forcan 150mg Capsules Fluconazole 150mg POM Capsule oral 099/036 Cipla Limited, India 1359 Forcan 200mg Capsules Fluconazole 200mg POM Capsule oral 099/037 Cipla Limited, India 1360 Vasopril -10 Tablets Enalapril 10mg POM Tablet Uncoated 099/038 Cipla Limited, India 1361 Vasopril 5 Tablets Enalapril 5mg POM Tablet Uncoated 099/039 Cipla Limited, India 1362 Acivir Eye Ointment Acyclovir 3% POM Eye Ointment 099/040 Cipla Limited, India 1363 Alerid Tablets Cetirizine 10mg POM Tablet Uncoated 099/041 Cipla Limited, India Calcium Carbonate P Tablet Uncoated 099/042 Cipla Limited, India Cipcal 250 Tablets 625mg + Vitamin D3 1364 1.66mg Ceftriaxone 1000mg POM Powder for 099/043 Cipla Limited, India Ciplacef Injection 1365 Injection Vincristine 1g POM Solution for 099/044 Cipla Limited, India Cytocristin Injection 1366 Injection Dr Smiths Evening Primrose Evening Primrose extract P Capsule oral 099/045 Cipla Limited, India 1367 Capsules 1368 Falcinil 100 Tablets Artesunate 100mg POM Tablet Uncoated 099/046 Cipla Limited, India 1369 Fincar 5mg Tablets Finasteride 5mg POM Tablets oral 099/047 Cipla Limited, India 1370 Gentacip Eye Drops Gentamycin 0.35%w/v POM Eye Drops 099/048 Cipla Limited, India 1371 Glinil Tablets Glibenclamide 5mg POM Tablet Uncoated 099/049 Cipla Limited, India 1372 Hipres-100 Tablets Atenolol 100mg POM Tablet Uncoated 099/050 Cipla Limited, India 1373 Hipres-50 Tablets Atenolol 50mg POM Tablet Uncoated 099/051 Cipla Limited, India Timolol 0.25%w/v POM Eye Drops 099/052 Cipla Limited, India Ocutin 0.25% Ophthalmic Drops 1374 1375 Ocutin 0.5% Ophthalmic Drops Timolol 0.5%w/v POM Eye Drops 099/053 Cipla Limited, India

Page 72 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Chondroitin 400mg + P Tablet Enteric 099/054 Cipla Limited, India Osteocip Tablets 1376 Glucosamine 663.2mg Coated Amphotericin B 50mg, POM Solution for 099/055 Cipla Limited, India Photericin B Injection 1377 per 15ml Injection 1378 Profenac 100 SR Tablets Diclofenac 100mg P Tablet Uncoated 099/056 Cipla Limited, India Quinine 300mg POM Solution for 099/057 Cipla Limited, India Quinarsol Injection 1379 Injection 1380 Roko 2 Tablets Loperamide 2mg POM Tablet Uncoated 099/058 Cipla Limited, India 1381 Synclar 250 Tablets Clarithromycin 250mg POM Tablet Uncoated 099/059 Cipla Limited, India 1382 Theoday 400mg Tablets Theophylline 2mg POM Tablet Uncoated 099/060 Cipla Limited, India 1383 Ultac 300 Tablets Ranitidine 300mg POM Tablet Uncoated 099/061 Cipla Limited, India 1384 Zinoral Shampoo Ketoconazole 2% POM Shampoo 099/062 Cipla Limited, India Lamivudine 150mg + POM Tablet Uncoated 099/063 Cipla Limited, India Triomune 30 Tablets Stavudine 30mg + 1385 Nevirapine 200mg 1386 Acivir Cream Acyclovir 5%w/w POM Cream Topical 099/064 Cipla Limited, India 1387 Natucil Powder Isphagula Husk 3.25g P Sachet 099/065 Cipla Limited, India 1388 Ciproric-100 Tablets Allopurinol 100mg POM Tablet Uncoated 099/067 Cipla Limited, India Methylergonovine POM Solution for 099/068 Cipla Limited, India Ergogin Injection 1389 0.208mg, per ml Injection Dexamethasone 4.38mg, POM Solution for 099/069 Cipla Limited, India Dexacip Injection 1390 per ml Injection Paracetamol 325mg + P Capsule oral 099/070 Cipla Limited, India Spasmocip Capsules 1391 Dextromethophan 65mg 1392 Cipladine Ointment Povidone Iodine 5%w/w GS Ointment topical 099/071 Cipla Limited, India Aluminium Hydroxide + GS Tablet Uncoated 099/072 Cipla Limited, India Digusil MPS Tablets Magnesium Hydroxide + 1393 Dimethicone 400mg Silver Sulfadiazine P Cream Topical 099/073 Cipla Limited, India Burnheal Cream 1%w/w + Chlorhexidine 1394 0.2%w/w 1395 Proflox 400 Tablets Profloxacin 400mg POM Tablet Uncoated 099/075 Cipla Limited, India Salbutamol 2mg + POM Tablet Uncoated 099/076 Cipla Limited, India Theo Asthalin Tablets 1396 Theophylline 100mg Salbutamol 110 mg + POM Powder for 099/077 Cipla Limited, India Aerocort Inhaler Beclometasone Inhalation 1397 51.67mcg 1398 Silagra-50 Tablets Sildenafil 50mg POM Tablet Uncoated 099/078 Cipla Limited, India

Page 73 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Povidone 6mg + polyvinyl POM Eye Drops 099/079 Cipla Limited, India Aqua Tears Drops alchol 14mg, per ml 1399 1400 Alerid Syrup Cetirizine 5mg, per 5ml POM Syrup 099/080 Cipla Limited, India 1401 Ciplactin Tablet Cyproheptadine 4mg P Tablet Uncoated 099/081 Cipla Limited, India Amoxicillin 500 + POM Tablet Uncoated 099/083 Cipla Limited, India Novaclav 625 Tablets Clavulanate Potassium 1402 125mg Sulphadoxine 500mg + P Tablet Uncoated 099/084 Cipla Limited, India Pyradox Tablets 1403 Pyrimethamine 25mg Halofantrine POM Tablet Uncoated 099/085 Cipla Limited, India Halotrin Tablets 1404 Hydrochloride 250mg Alpha Tocopherol 400mg POM Capsule oral 099/087 Cipla Limited, India Dr Smith Vitamin Capsules 1405 Theophylline 300mg + POM Tablet Uncoated 099/088 Cipla Limited, India Theo Asthalin Tablets 1406 Salbutamol 4.8mg Amoxicillin 250mg + POM Tablet Uncoated 099/089 Cipla Limited, India Novaclav 375 Tablets Clavulanate Potassium 1407 125mg Ginseng + Minerals + GS Capsule oral 099/090 Cipla Limited, India Vitacip Capsules 1408 Multivitamins 1409 Asthalin SR Tablets Salbutamol 4mg POM Tablet Uncoated 099/092 Cipla Limited, India 1410 Cephadex-500 Tablets Cephalexin 500mg POM Capsule oral 099/093 Cipla Limited, India 1411 Cephadex 250 Capsules Cephalexin 250mg POM Capsule oral 099/094 Cipla Limited, India Sodium Ascorbate 394 GS Tablet Chewable 099/095 Cipla Limited, India C-Vit Chewable Tablets mg + Ascorbic Acid 1412 150mg 1413 Betavit AFR Capsules Vitamins P Capsule oral 099/096 Cipla Limited, India 1414 Ritomune Tablets Ritonavir 100mg POM Tablet Uncoated 099/099 Cipla Limited, India Lamivudine 150mg + POM Tablet Uncoated 099/101 Cipla Limited, India Duovir Tablets 1415 Zidovudine 300mg 1416 Nevimune 200 Tablets Nevirapine 200mg POM Tablet Uncoated 099/102 Cipla Limited, India Sulfamethoxazole 400mg POM Tablet Uncoated 099/103 Cipla Limited, India Ciplin Tablets + Trimethoprim 80mg 1417 Artemether 20mg + POM Tablet Uncoated 099/104 Cipla Limited, India Lumartem Tablets 1418 Lumefantrine 120mg 1419 Dr Smith's Garlic Oil Capsules Garlic Oil 0.25%w/w GS Capsule oral 099/105 Cipla Limited, India

Page 74 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Sodium Bicarbonate GS Powder for Oral 099/106 Cipla Limited, India 44.03 % + Sodium Citrate Solution Urisoda Granules 15.75 % + Tartaric Acid 22.25 % + Citric Acid 1420 17.88 % Alpha Tocopherol 200mg POM Capsule oral 099/107 Cipla Limited, India Dr. Smith's Vitamin E Capsules 1421 Lamivudine 30mg + POM Tablet Uncoated 099/108 Cipla Limited, India Triomune Baby Tablets Nevirapine 50mg + 1422 Stavudine 6mg Lamivudine 60mg + POM Tablet Uncoated 099/109 Cipla Limited, India Triomune Junior Tablets Nevirapine 100mg + 1423 Stavudine 12mg Lamivir S Baby Dispersible Lamivudine 30mg + POM Tablet Dispersible 099/110 Cipla Limited, India 1424 Tablets Stavudine 6mg Lamivir S Junior Dispersible Lamivudine USP 12mg + POM Tablet Dispersible 099/111 Cipla Limited, India 1425 Tablets Stavudine USP 60mg 1426 Stavir Dry Syrup Stavudine 1mg, per ml POM Syrup 099/112 Cipla Limited, India Amoxicillin 125mg + POM Syrup 099/113 Cipla Limited, India Novaclav Dry Syrup Clavulanic Acid 31.25mg, 1427 per 5ml Ciprofloxacin 2mg, per POM Solution for 099/115 Cipla Limited, India Ciplox IV Infusion 1428 ml infusion Metronidazole 500mg, POM Solution for 099/116 Cipla Limited, India Flazole Injection 1429 per 100ml Injection Hydrocortisone 100mg POM Powder for 099/117 Cipla Limited, India Cipcorlin Injection 1430 Injection Cisplatin 50mg POM Powder for 099/118 Cipla Limited, India Cytoplatin Injection 1431 Injection 1432 Cytotam 10mg Tablets Tamoxifen 10mg POM Tablet Uncoated 099/119 Cipla Limited, India Bleomycin 15 units POM Powder for 099/120 Cipla Limited, India Bleomcip Injection 1433 Injection Etoposide 100mg, per POM Powder for 099/121 Cipla Limited, India Etosid Injection 1434 5ml Injection 1435 Cytotam 20g Tablets Tamoxifen 20mg POM Tablet Uncoated 099/122 Cipla Limited, India Carboplatin 150mg, per POM Powder for 099/123 Cipla Limited, India Cytocarb 150 Injection 1436 15ml Injection Dacarbazine 200mg POM Powder for 099/124 Cipla Limited, India Decarb 200 Injection 1437 Injection

Page 75 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 1438 Ciplactin Syrup Cyproheptadine 2mg P Syrup 099/125 Cipla Limited, India 1439 Naxid Tablets Nalidixic Acid 500mg POM Tablet Uncoated 099/126 Cipla Limited, India Tenofovir Disoproxil POM Tablet Film coated 099/127 Cipla Limited, India Tenvir Tablets 1440 Fumarate 300 mg 1441 Abacavir Sulphate Tablets Abacavir 300mg POM Tablet Uncoated 099/128 Cipla Limited, India Lamivudine 10mg/ml Oral Lamivudine 10mg, per ml POM Solution for Oral 099/129 Cipla Limited, India 1442 Solution Use 1443 Efavirenz 600mg Tablets Efavirenz 600mg POM Tablet Uncoated 099/130 Cipla Limited, India 1444 Nevirapine 200mg Tablets Nevirapine 200mg POM Tablet Film coated 099/131 Cipla Limited, India 1445 Tinidazole Tablets Tinidazole 500mg POM Tablet Uncoated 099/138 Cipla Limited, India Lansoprazole 30mg + POM Tablet Uncoated 099/139 Cipla Limited, India Pylokit Tablets Tinidazole 500mg + 1446 Clarithromycin 250mg Paracetamol 200mg + P Tablet Uncoated 099/140 Cipla Limited, India Ibugesic Plus Tablets 1447 Ibuprofen 325mg Tamsulosin POM Tablets oral 099/141 Cipla Limited, India Urimax 0.2mg Tablets 1448 Hydrochloride 0.2mg Methylergonovine POM Tablet Uncoated 099/142 Cipla Limited, India Ergogin Tablets 1449 0.125mg Clarithromycin 125mg, POM Syrup 099/143 Cipla Limited, India Synclar Dry Syrup 1450 per 5ml Nystatin 100,000 IU, per POM Suspension for 099/144 Cipla Limited, India Nystatin Oral Suspension 1451 ml Oral Use Diclofenac 25mg, per POM Solution for 099/146 Cipla Limited, India Profenac Injection 1452 3ml Injection Gentamycin 40mg, per ml POM Solution for 099/147 Cipla Limited, India Gentacip Injection 1453 Injection Salbutamol 100mcg, per POM Powder for 099/148 Cipla Limited, India Asthalin CFC-Free Inhaler 1454 spray Inhalation Sulphamethoxazole POM Suspension for 099/151 Cipla Limited, India Ciplin Suspension 200mg + Trimethoprim Oral Use 1455 40mg Beclomethasone 50mcg, POM Powder for 099/152 Cipla Limited, India Beclate 50 Inhaler 1456 per spray Inhalation Beclomethasone 50mcg, POM Powder for 099/153 Cipla Limited, India Beclate 50 Inhaler 1457 per dose Inhalation Artesunate 50mg + POM Tablet Uncoated 099/154 Cipla Limited, India Sulfamon Plus Tablets Pyrimethamine 25mg + 1458 Sulfadoxine 500mg

Page 76 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Pyrimethamine 25mg + POM Tablet Uncoated 099/155 Cipla Limited, India Sulphamon Plus Tablets Sulphadoxine 500mg + 1459 Artesunate 50mg 1460 Abacavir Tablets 300mg Abacavir tablets 300mg POM Tablet Film coated 099/157 Cipla Limited, India 1461 Indivan 400mg Capsules Indinavir 400mg POM Capsule oral 099/158 Cipla Limited, India 1462 Stavir 15 Capsules Stavudine 15mg POM Capsule oral 099/159 Cipla Limited, India 1463 Stavir 20 Capsules Stavudine 20mg POM Capsule oral 099/160 Cipla Limited, India 1464 Divir 25 Tablets Didanosine 25mg POM Tablet Dispersible 099/161 Cipla Limited, India 1465 Divir 150 Tablets Didanosine 150mg POM Tablet Dispersible 099/162 Cipla Limited, India 1466 Divir 200 Tablets Didanosine 200mg POM Tablet Dispersible 099/163 Cipla Limited, India 1467 Zidovudine 100mg Capsules Zidovudine 100mg POM Capsule oral 099/164 Cipla Limited, India Doxorubicin 10mg, per POM Powder for 099/165 Cipla Limited, India Oncodox 10 Injection 1468 2.5ml Injection Doxorubicin 50mg, per POM Powder for 099/166 Cipla Limited, India Oncodox 50 Injection 1469 5ml Injection Amoxicillin 125mg, per POM Powder for Oral 099/167 Cipla Limited, India Amoxicillin Oral Suspension 1470 5ml Suspension 1471 Amoxicillin Capsules Amoxicillin 250mg POM Capsule oral 099/168 Cipla Limited, India Ethinyl Estradiol 0.035mg POM Tablet Uncoated 099/169 Cipla Limited, India Ginette 35 Tablets + Cyproterone 2mg 1472 Cefixime 50mg, per 5ml POM Powder for Oral 099/170 Cipla Limited, India Cefix Ds Oral Suspension 1473 Suspension 1474 Warf 5 Tablets Warfarin 5mg POM Tablet Uncoated 099/171 Cipla Limited, India Chloramphenicol 1g POM Powder for 099/172 Cipla Limited, India Chloraxin Injection 1475 Injection 1476 Paracip 500 Tablets Paracetamol 500mg GS Tablet Uncoated 099/173 Cipla Limited, India Furosemide 10mg, per ml POM Solution for 099/174 Cipla Limited, India Frusix Injection 1477 Injection 1478 Ibugesic- 400 Tablets Ibuprofen 400mg P Tablet Uncoated 099/175 Cipla Limited, India Tenofovir 300mg + POM Tablet Uncoated 099/177 Cipla Limited, India Tenvir-EM Tablets 1479 Emtricitabine 200mg 1480 Lanzol 30 Capsules Lansoprazole 30mg POM Capsule oral 099/178 Cipla Limited, India Alumimium Hydroxide GS Solution for Oral 099/179 Cipla Limited, India 250mg + Magnesium Use Digusil MPS Liquid Hydroxide 250mg + Dimethicone 50mg, per 1481 5ml

Page 77 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Fluticasone 50mcg, per POM Solution for 099/180 Cipla Limited, India Flomist Nasal Spray 1482 spray Inhalation Artemether 40mg + POM Tablet Uncoated 099/181 Cipla Limited, India Lumet Forte Tablets 1483 Lumefantrine 240mg Cod-liver oil 300mg GS Capsule oral 099/182 Cipla Limited, India Seaking Cod Liver Oil Capsules 1484 Terbinafine 1%w/w POM Spray for Topical 099/183 Cipla Limited, India Terbi Spray 1485 Use 1486 Divir-50 Tablets Didanosine 50mg POM Tablet Dispersible 099/184 Cipla Limited, India Tenofovir 300mg + POM Tablet Film coated 099/185 Cipla Limited, India Viraday Tablets Emtricitabine 200mg + 1487 Efavirenz 600mg 1488 Gatiquin-400mg Tablets Gatifloxacin 400mg POM Tablet Uncoated 099/186 Cipla Limited, India 1489 Gatiquin-200mg Tablets Gatifloxacin 200mg POM Tablet Uncoated 099/187 Cipla Limited, India Sodium chloride + GS Powder for Oral 099/188 Cipla Limited, India Sodium citrate + Solution Prolyte Oral Rehydration Patassium chloride + 1490 Dextrose Ascorbic Acid 500mg GS Effervescent 099/189 Cipla Limited, India C-Fizz 500 Tablets 1491 Tablets Paracetamol 500mg GS Effervescent 099/190 Cipla Limited, India Parafizz Tablets 1492 Tablets Artesunate 50mg + POM Tablet Film coated 099/191 Cipla Limited, India Falcimon B/L Tablets 1493 Amodiaquine 153mg Abacavir 20mg, per ml POM Solution for Oral 099/192 Cipla Limited, India Abacavir Sulfate Oral Solution 1494 Use Lopinavir 200mg + POM Tablet Film coated 099/193 Cipla Limited, India Lopimune Tablets 1495 Ritonavir 50mg 1496 Misoprost -25 Tablets Misoprostol 25mcg POM Tablet Uncoated 099/194 Cipla Limited, India 1497 Misoprost - 200 Tablets Misoprostol 200mcg POM Tablet Uncoated 099/195 Cipla Limited, India 1498 C - Fizz 1000 Tablets Ascorbic Acid 1000mg GS Tablet Dispersible 099/196 Cipla Limited, India 1499 Oflox-200 Tablets Ofloxacin 200mg POM Tablet Film coated 099/197 Cipla Limited, India 1500 Oflox -400 Tablets Ofloxacin 400mg POM Tablet Film coated 099/198 Cipla Limited, India 1501 Levofloxacin 250 Tablets Levofloxacin 250mg POM Tablet Uncoated 099/199 Cipla Limited, India 1502 Levofloxacin 500 Tablets Levofloxacin 500mg POM Tablet Uncoated 099/200 Cipla Limited, India Zoledronic Acid 4.0mg POM Solution for 099/201 Cipla Limited, India Zoldria Injection 1503 Injection Ethionamide Tablets USP Ethionamide 250mg POM Tablet Enteric 099/202 Cipla Limited, India 1504 250mg Coated

Page 78 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 1505 Glimcip - 1 Tablets Glimepiride 1mg POM Tablet Uncoated 099/203 Cipla Limited, India 1506 Glimcip-2 Tablets Glimepiride 2mg POM Tablet Uncoated 099/204 Cipla Limited, India 1507 Atorlip-20 Tablets Atorvastatin 20mg POM Tablet Uncoated 099/205 Cipla Limited, India 1508 Cresar - 40 Tablets Telmisartan 40mg POM Tablet Uncoated 099/206 Cipla Limited, India 1509 Cresar - 20 Tablets Telmisartan 20mg POM Tablet Uncoated 099/207 Cipla Limited, India 1510 Atorlip - 40 Tablets Atorvastatin 40mg POM Tablet Uncoated 099/208 Cipla Limited, India 1511 Atorlip- 10 Tablets Atorvastatin 10mg POM Tablet Uncoated 099/209 Cipla Limited, India 1512 Minovit - P Tablets Multivitamins GS Tablet Uncoated 099/210 Cipla Limited, India Menthol 7.1mg + GS Lozenges 099/211 Cipla Limited, India Rapid Relief Lozenges 1513 Peppermint 7.1mg 1514 Abamune 60 Tablets Abacavir 60mg POM Tablet Dispersible 099/212 Cipla Limited, India Diphenhydramine 25mg P Solution for Oral 099/213 Cipla Limited, India Cof-Ryl Cough Syrup 1515 Use Paracetamol 400mg + P Tablet Uncoated 099/214 Cipla Limited, India Sinu Flu Tablets Phenylephrine 5mg + 1516 Mepyramine 8mg Trimethoprim 800mg + POM Tablet Uncoated 099/215 Cipla Limited, India Ciplin DS Tablets Sulphamethoxazole 1517 180mg Abacavir 60mg + POM Tablet Uncoated 099/216 Cipla Limited, India Abamune-L Baby Tablets 1518 Lamivudine 30mg Abacavir Sulphate 600mg POM Tablet Film coated 099/217 Cipla Limited, India Abacavir Sulphate & Lamivudine + Lamivudine 300mg Tablets 600/300mg 1519 Lamivudine 30mg + POM Tablet Film coated 099/218 Cipla Limited, India Duovir Baby Tablets 1520 Zidovudine 60mg Levonogestrel BP POM Tablet Uncoated 099/219 Cipla Limited, India PILL 72 1521 0.75mg 1522 I-Pill Tablets Levonorgestrel 1.5mg POM Tablet Uncoated 099/220 Cipla Limited, India Montelukast Sodium BP POM Tablet Uncoated 099/221 Cipla Limited, India Montair-5 CW Tablets 1523 5mg Praziquantel Tablets USP Praziquantel USP POM Tablets oral 099/222 Cipla Limited, India 1524 600mg 600mg Salmeterol 25mcg + POM Solution for 099/223 Cipla Limited, India Seroflo 250 Inhaler 1525 Fluticasone 250mcg Inhalation Paraffiz 1000 Effervescent Paracetamol 1000mg POM Tablet Effervescent 099/224 Cipla Limited, India 1526 Tablets

Page 79 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Efavirenz 600mg + POM Tablet Film coated 099/225 Cipla Limited, India Efavirenz, Lamivudine and Lamivudine 300mg + Tenofovir Disoproxil Fumarate Tenofovir Disoproxil Tablets 1527 Fumarate 300mg Mometasone Furoate POM Nasal spray 099/227 Cipla Limited, India Nasehaler Nasal Spray 1528 Nasal Spray 50 mcg Salmeterol 25mcg + POM Solution for 099/228 Cipla Limited, India Seroflo 125 Inhaler 1529 Fluticasone 125mcg Inhalation Sulfamethoxazole 800mg POM Tablet Uncoated 099/228 Cipla Limited, India + Trimethoprim 160mg + Q-TIB Tablets Isoniazid 300mg + Pyridoxine Hydrochloride 1530 25mg Lamivudine 300 mg and POM Tablet Film coated 099/229 Cipla Limited, India Lamivudine and Tenofovir Tenofovir Disoproxil Disoproxil Fumarate Tablets Fumarate Tablets 300mg 300/300 Mg 1531 1532 Nifelat Retard Tablet Nifedipine 20mg POM Tablet Film Coated 099/230 Cipla Limited, India Atazanavir Sulfate and Ritonavir Atazanavir Sulfate 300mg POM Tablet Film coated 099/240 Cipla Limited, India Tablets 300mg/ 100mg + Ritonavir 100mg 1533 Imatib 100 Capsules Imatinib Mesylate 100mg POM Capsule oral 099/241 Cipla Limited, India 1534 Capsules Imatib 400 Capsules Imatinib Mesylate 400mg POM Capsule oral 099/242 Cipla Limited, India 1535 Capsules Efavirenz 600mg + POM Tablet Film coated 099/226 Cipla Quality Chemical Industries Limited Lamivudine 300mg + (Cipla QCIL) Trioday Tablets Tenofivir Disoproxyl 1536 Fumurate 300mg Paracetamol 125mg, per GS Syrup 002/001 Ciron Drugs & Pharmaceuticals Ltd, India Anmol Syrup 1537 5ml Betamethasone 0.1% + POM ear/eye Drops 002/002 Ciron Drugs & Pharmaceuticals Ltd, India Betnew Ear/Eye Drops 1538 Neomycin 0.5% w/v Chlorpheniramine P Tablet Uncoated 002/003 Ciron Drugs & Pharmaceuticals Ltd, India Chlorpheniramine Tablets 1539 Maleate 4mg Promethazine P solution 002/004 Ciron Drugs & Pharmaceuticals Ltd, India Cirogan Syrup Hydrochloride oral 1540 solution 5mg, per 5ml 1541 Cirovit Syrup Multivitamins GS Syrup 002/005 Ciron Drugs & Pharmaceuticals Ltd, India

Page 80 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Paracetamol BP 125mg + P Syrup 002/006 Ciron Drugs & Pharmaceuticals Ltd, India Chlopheniramine Maleate Cold Plus Syrup BP 2.5mg + Phenylephirine HCL BP 1542 2.5mg Sulfamethoxazole 200 POM Suspension for oral 002/007 Ciron Drugs & Pharmaceuticals Ltd, India Co-trimoxazole Paediatric Oral mg + Trimethoprime 40 use Suspension 1543 mg Dexamethasone Sodium POM Ear/Eye Drops 002/008 Ciron Drugs & Pharmaceuticals Ltd, India Dexamethasone Ear/Eye Drops Phosphate Ophthalmic 1544 Solution USP 0.1%w/v Dextrose 50% USP POM Solution for 002/009 Ciron Drugs & Pharmaceuticals Ltd, India Dextrose Injection 1545 Injection Menthol 0.55mg + P Syrup 002/010 Ciron Drugs & Pharmaceuticals Ltd, India Diphenhydramine Hydrochloride 7mg + Kofex Syrup Ammonium Chloride 67.50mg + Sodium 1546 Citrate 28.50mg Menthol + Eucalyptus + P Tablet Uncoated 002/011 Ciron Drugs & Pharmaceuticals Ltd, India Kofex Cough Tablets Liquorice + Anise oil + 1547 Metha oil Peppermint oil BP P Syrup 002/012 Ciron Drugs & Pharmaceuticals Ltd, India 0.035ml + Menthol Kofmint Syrup BP5mg + Alcohol 2.4%w/v + Benzoic Acid 1548 BP 0.18%w/v Mebendazole 100mg, per P Suspension for 002/013 Ciron Drugs & Pharmaceuticals Ltd, India Mebendazole Oral Suspension 1549 5ml Oral Use Xylometazoline P Nasal drops 002/014 Ciron Drugs & Pharmaceuticals Ltd, India Cirovin Nasal Drops 0.1% 1550 Hydrochloride 0.1% Xylometazoline P Nasal drops 002/015 Ciron Drugs & Pharmaceuticals Ltd, India Cirovin Nasal Drops 0.5% 1551 Hydrochloride 0.5% Chloramphenicol 0.5w/v POM Eye Drops 002/016 Ciron Drugs & Pharmaceuticals Ltd, India Chloramphenicol Eye Drops 0.5 1552 Chlopheniramine Maleate POM Tablet Uncoated 002/017 Ciron Drugs & Pharmaceuticals Ltd, India Chlorpheniramine Tablets 1553 USP 4mg 1554 Ibuprofen Tablets Ibuprofen BP 200mg P Tablet Film coated 002/018 Ciron Drugs & Pharmaceuticals Ltd, India

Page 81 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Erythromycin 125mg, per POM Powder for Oral 002/019 Ciron Drugs & Pharmaceuticals Ltd, India Erythromycin Dry Powder 1555 5ml Suspension 1556 Propranolol Tablets Propranolol BP 40mg POM Tablet Uncoated 002/021MT Ciron Drugs & Pharmaceuticals Ltd, India Hydralazine POM Tablet Uncoated 002/022MT Ciron Drugs & Pharmaceuticals Ltd, India Hydralazine Tablets 1557 Hydrochloride BP 25mg 1558 Fluconazole Capsules Fluconazole 200mg POM Capsule oral 002/023 Ciron Drugs & Pharmaceuticals Ltd, India Ketamine Hydrochloride POM Solution for 002/024 Ciron Drugs & Pharmaceuticals Ltd, India Ket Injection 1559 IP 50mg, per ml Injection Paradichlorobenzene P Solution for Topical 002/025 Ciron Drugs & Pharmaceuticals Ltd, India Cirowax Ear Drops 1560 2%w/v Use Amphotericin B 50mg/ Vial Amphotericin B 50mg POM Powder for 002/025MT Ciron Drugs & Pharmaceuticals Ltd, India 1561 Injection Injection Metronidazole 250mg, POM Suspension for 002/026 Ciron Drugs & Pharmaceuticals Ltd, India Metronidazole Oral Suspension 1562 per 5ml Oral Use 1563 Digoxin Tablets Digoxin 0.25mg POM Tablet Uncoated 002/026MT Ciron Drugs & Pharmaceuticals Ltd, India 1564 Ciprofloxacin Tablets Ciprofloxacin BP 250mg POM Tablet Uncoated 002/027MT Ciron Drugs & Pharmaceuticals Ltd, India 1565 Peridol Tablets Haloperidol 5mg POM Tablet Uncoated 002/028 Ciron Drugs & Pharmaceuticals Ltd, India Heparin Sodium BP 5000 POM Solution for 002/029MT Ciron Drugs & Pharmaceuticals Ltd, India Oparin Injection 1566 IU, per ml Injection Hydrocortisone Sodium POM Powder for 002/030MT Ciron Drugs & Pharmaceuticals Ltd, India Hydrocortisone Injection Succinate BP 100mg, per Injection 1567 ml Fluconazole USP 2mg, POM Solution for 194/002 Claris injectable Ltd, India Flucanol Injection 1568 per ml Injection Propofol 1% Intravenous Propofol 10mg POM Solution for 194/003 Claris injectable Ltd, India 1569 Injection Injection Ketamine BP 50mg, per POM Solution for 194/004 Claris injectable Ltd, India Ketajex IV Injection 1570 ml Injection Cefotaxime 1gm POM Powder for 194/005 Claris injectable Ltd, India Cefo Injection 1571 Injection Thiopental Sodium 1g POM Powder for 194/006 Claris injectable Ltd, India Thiopental Injection 1572 Injection Bupivacaine POM Solution for 194/007 Claris injectable Ltd, India Bupican Injection 1573 Hydrochloride BP 0.5w/v Injection Ceftriaxone Sodium POM Solution for 194/010 Claris injectable Ltd, India Curaxone Injection 1574 1000mg Injection Diclofenac Sodium 25mg, POM Solution for 194/012 Claris injectable Ltd, India Dflam Injection 1575 per ml Injection

Page 82 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Metoclopramide 5mg, per POM Solution for 194/014 Claris injectable Ltd, India Remetin Injection 1576 ml Injection Dopamine concentrate POM Solution for 194/008 Claris injectableLtd, India Dopamine Injection 1577 BP 40mg, per ml Injection Tamin Intravenous infusion Paracetamol 10mg/ml POM Powder for 194/019 Claris Life Sciences Ltd, India 1578 Injection Hydroxyethyl Starch POM Solution for 194/001 Claris Otsuka Private Limited Hestar 200 Pestastarch Infusion 1579 6%w/v Injection Lidocaine BP 21.3mg, POM Solution for 194/011 Claris Otsuka Private Limited Sensinil Injection 1580 per ml Injection 1581 Protex Men Fresh Bar Soap Anti bacterial soap GSL Solid Soap 383/001L Colgate-Palmolive. RSA Protex Men Herbal 100 Bar Anti bacterial soap with GSL Solid Soap 383/002L Colgate-Palmolive. RSA 1582 Soap herbal extracts Protex Men Herbal 175g Bar Anti bacterial soap with GSL Solid Soap 383/003L Colgate-Palmolive. RSA 1583 Soap herbal extracts Antibacterial soap with GSL Solid Soap 383/004L Colgate-Palmolive. RSA Protex Men Aloe Bar Soap 1584 Aloe vera 1585 Protex Men Power Bar Soap Antibacterial soap GSL Solid Soap 383/005L Colgate-Palmolive. RSA Protex African Therapy Bar Antibacterial soap GSL Solid Soap 383/006L Colgate-Palmolive. RSA 1586 Soap Protex Deep Clean 100g Bar Antibacterial soap GSL Solid Soap 383/007L Colgate-Palmolive. RSA 1587 Soap 1588 Protex Men Sport Bar Soap Antibacterial soap GSL Solid Soap 383/008L Colgate-Palmolive. RSA 1589 Protex Men Energy Bar Soap Antibacterial soap GSL Solid Soap 383/009L Colgate-Palmolive. RSA Antibacterial soap with GSL Solid Soap 383/010L Colgate-Palmolive. RSA Protex Men Propolis Bar Soap 1590 Propolis 1591 Protex Men Classic Bar Soap Antibacterial soap GSL Solid Soap 383/011L Colgate-Palmolive. RSA Protex Deep Clean 175g Bar Antibacterial soap GSL Solid Soap 383/012L Colgate-Palmolive. RSA 1592 Soap 1593 Protex Fresh Shower Gel Antibacterial shower gel GSL Gel Topical 383/013L Colgate-Palmolive. RSA Antibacterial shower gel GSL Gel Topical 383/014L Colgate-Palmolive. RSA Protex Vit E Shower Gel 1594 with Vitamin E Antibacterial shower gel GSL Gel Topical 383/015L Colgate-Palmolive. RSA Protex Men Sport Shower Gel 1595 with Vitamin E Protex Fresh Men Energy Antibacterial shower gel GSL Gel Topical 383/016L Colgate-Palmolive. RSA 1596 Shower Gel with Vitamin E Dried Ferrous Sulphate P Tablet Film coated 201/001 Colorama Pharmaceuticals Ltd, UK Ferrous Sulphate Tablets 1597 200mg 1598 Loperamide Tablets Loperamide 2mg POM Tablet Uncoated 201/002 Colorama Pharmaceuticals Ltd, UK

Page 83 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Tetracycline POM Ointment topical 201/003 Colorama Pharmaceuticals Ltd, UK Tetracycline Eye Ointment 1599 Hydrochloride 1%w/w 1600 Tetracyline Capsules Tetracycline 1% POM Capsule oral 201/004 Colorama Pharmaceuticals Ltd, UK Metformin 500mg + POM Tablet Uncoated 201/005 Colorama Pharmaceuticals Ltd, UK Forzid Tablets 1601 Gliclazide 80mg Pyrantel Pamoate 25mg, POM Suspension for 201/008 Colorama Pharmaceuticals Ltd, UK Pymint Oral Suspension 1602 per ml Oral Use Metronidazole 100mg + POM Tablets Oral 201/009 Colorama Pharmaceuticals Ltd, UK Trolox Tablets 1603 Norfloxacin 200mg Tolnaftate 10mg + POM Topical cream 201/010 Colorama Pharmaceuticals Ltd, UK Iodochlorhydroxyquinolon Tocure Skin Cream 15mg Tube e 10mg + Gentamycin 1mg + Betamethasone 1604 0.61mg Metronidazole 100mg + POM Suspension for 201/011 Colorama Pharmaceuticals Ltd, UK Trolox Suspension Norfloxacin 100mg, per Oral Use 1605 5ml Pyrantel pamoate 125mg POM Tablets oral 201/012 Colorama Pharmaceuticals Ltd, UK Pymint Tablets 1606 1607 Odopa Tablets Methyldopa 250mg POM Tablet Uncoated 201/013 Colorama Pharmaceuticals Ltd, UK Amlodipine 5mg + POM Tablet Uncoated 201/014 Colorama Pharmaceuticals Ltd, UK Lopine Tablets 1608 Atenolol 50mg Pyrantel pamoate 25mg, P Suspension for 201/015 Colorama Pharmaceuticals Ltd, UK Pymint Oral Suspension 1609 per ml Oral Use Metronidazole 200mg + POM Tablet Uncoated 201/016 Colorama Pharmaceuticals Ltd, UK Trolox Tablets 1610 Norfloxacin 200mg Tolnaftate + POM Cream Topical 201/017 Colorama Pharmaceuticals Ltd, UK Iodochlorhydroxyquinolon Tocure Cream e + Gentamycin + 1611 Betamethazone Metronidazole 100mg + POM Suspension for 201/018 Colorama Pharmaceuticals Ltd, UK Trolox Suspension Norfloxacin 100mg, per Oral Use 1612 5ml Pyrantel Pamoate 125mg P Tablet Uncoated 201/019 Colorama Pharmaceuticals Ltd, UK Pymint Tablets 1613 1614 Hydrocortisone Acetate Cream Hydrocortisone 1% POM Cream Topical 201/021 Colorama Pharmaceuticals Ltd, UK 1615 Canaderm-V6 Tablets Clotrimazole BP 100mg POM Tablet Uncoated 201/023 Colorama Pharmaceuticals Ltd, UK 1616 Onystin-V Tablets Nystatin 100,000 IU POM Tablet Uncoated 201/024 Colorama Pharmaceuticals Ltd, UK

Page 84 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Betamethasone P Cream Topical 201/025 Colorama Pharmaceuticals Ltd, UK Cobet Cream 1617 Valearate BP 0.1%w/w 1618 Onapril Tablets Enalapril Maleate 20mg POM Tablet Uncoated 201/026 Colorama Pharmaceuticals Ltd, UK 1619 Onapril Tablets Enalapril Maleate 5mg POM Tablet Uncoated 201/027 Colorama Pharmaceuticals Ltd, UK 1620 Onapril Tablets Enalapril Maleate 10mg POM Tablet Uncoated 201/028 Colorama Pharmaceuticals Ltd, UK Diacerein 50 mg + P Capsule oral 263/001 Comed chemicals Ltd, India Glucosamine 750 mg + Recartix Capsules Methylsulfonylmethane 1621 250 mg Calcium Dobesilate P Capsule oral 263/002 Comed chemicals Ltd, India Caldob Capsules 1622 500mg Diclofenac 50mg + POM Tablet Uncoated 263/003 Comed chemicals Ltd, India Lyser D Tablets 1623 Serrapeptase 10mg 1624 Simvax 20 Tablets Simvastatin 20mg POM Tablet Film coated 263/004 Comed chemicals Ltd, India 1625 Simvax 10 Tablets Simvastatin 10mg POM Tablet Film coated 263/005 Comed chemicals Ltd, India 1626 Ceso-40 Tablets Esomeprazole 40mg POM Tablet Uncoated 263/006 Comed chemicals Ltd, India 1627 Osex Capsules Hydroxyapatite P Capsule oral 263/007 Comed chemicals Ltd, India Glucosamine 250mg + P Tablet Uncoated 263/008 Comed chemicals Ltd, India Recartix Forte Tablets Condroitin 200mg + 1628 Minerals Pantoprazole + POM Capsule oral 263/009 Comed chemicals Ltd, India Proloc D Capsules 1629 Domperidone Chlorzoxazone 250mg + P Tablet Uncoated 263/010 Comed chemicals Ltd, India Dolomed MR Tablets Paracetamol 325mg + 1630 Ibuprofen 400mg Metronidazole Benzoate POM Gel Topical 379/001 Coral Laboratories Ltd Cornizole Denta Gel 1631 BP 1% w/v Clotrimazole USP 1%w/w POM Cream Topical 379/002 Coral Laboratories Ltd Dermagaurd Cream 1632 Cyproheptidine 2mg, per P 379/003 Power Appetite Syrup Syrup Coral Laboratories Ltd 1633 5ml 1634 Mylax-L Syrup Lactulose 10gm P Syrup 303/001 Corona Remedies Pvt Limited Aceclofenac 100mg + P Tablet Uncoated 303/002 Corona Remedies Pvt Limited Asera P Tablets 1635 Paracetamol 500mg 1636 Cetcor Tablets Cetirizine 10mg P Tablet Uncoated 303/003 Corona Remedies Pvt Limited Amlodipine Besylate 5mg POM Tablet Uncoated 317/001 Cosmos Limited, Kenya Varinil 5 Tablets 1637 Atorvastalin Calcium POM Tablet Film coated 317/002 Cosmos Limited, Kenya Avastatin-10 Tablets 1638 Trihydrate 10mg

Page 85 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Atorvastalin Calcium POM Tablet Uncoated 317/003 Cosmos Limited, Kenya Avastatin-20 Tablets 1639 Trihydrate 20mg 1640 Vidol Film Coated Tablets Carvedilol BP 6.25mg POM Tablet Film coated 317/004 Cosmos Limited, Kenya Amlodipine Besylate USP POM Tablet Uncoated 317/005 Cosmos Limited, Kenya Varinil 10 Tablets 1641 10mg 1642 Vidol 25 Tablets Carvedilol BP 25mg POM Tablet Film coated 317/006 Cosmos Limited, Kenya 1643 Zithrox 500 Tablets Azithromycin 500mg POM Tablet Uncoated 317/007 Cosmos Limited, Kenya 1644 Celprotec 200 Mcg Misoprostol 200 mcg POM Tablet Uncoated 405/001 Cospharm Investments (Pty) Ltd Trimethoprim 25mg + POM Tablet Uncoated 180/001 Crown Exports, India Softrim Tablets Sulfamethoxazole 500mg 1645 Pyrimthamine 80mg + POM Tablet Uncoated 180/002 Crown Exports, India Quintex Tablets 1646 Sulfadoxine 400mg Metronidazole BP 200mg POM Tablet Uncoated 180/003 Crown Exports, India Crogyl 200 Tablets 1647 1648 Paridol 500 Tablets Paracetamol BP 500mg P Tablet Uncoated 180/004 Crown Exports, India Ampicillin Trihydrate POM Capsule oral 180/005 Crown Exports, India Amicare 250 Capsules 1649 250mg Chlorpheniramine P Tablet Uncoated 180/006 Crown Exports, India Cromin Tablets 1650 Maleate 4mg Ciprofloxacin POM Tablet Uncoated 180/007 Crown Exports, India Ciprocrown 500 Tablets 1651 Hydrochloride 500mg 1652 Ibusoft 200 Tablets Ibuprofen 200mg P Tablet Uncoated 180/008 Crown Exports, India Dried Aluminium P Tablet Uncoated 180/010 Crown Exports, India Hydrochloride 120mg + Claricid Tablets Magnesium Trisilicate 1653 250mg 1654 Vitacrown Syrup Multivitamin P Syrup 180/011 Crown Exports, India 1655 Becofit Tablets Vitamon B Complex P Tablet Uncoated 180/012 Crown Exports, India Betamethasone POM Tablet Uncoated 180/013 Crown Exports, India Erysoft Syrup 1656 0.05%w/w Diphenhydramine P Syrup 180/014 Crown Exports, India Hydrochloride 14mg + Ammonium Chloride Cofdry Syrup 138mg + Sodium Citrate 57.03mg + Menthol 1657 1.14mg/5ml Amoxicillin 125mg, per POM Suspension for 079/001 CSPC Ouyi Pharmaceuticals Co. Ltd, China Amoxicillin Suspension 1658 5ml Oral Use

Page 86 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Cefotaxime 1.0g POM Powder for 079/002 CSPC Ouyi Pharmaceuticals Co. Ltd, China Cefotaxime Injection 1659 Injection Diclofenac Sodium POM Solution for 079/003 CSPC Ouyi Pharmaceuticals Co. Ltd, China Diclofenac Injection 1660 75mg, per 5ml Injection Doxycycline 100mg POM Tablet Uncoated 079/004 CSPC Ouyi Pharmaceuticals Co. Ltd, China Doxycycline Tablets 1661 Magnesium Sulphate POM Solution for 079/005 CSPC Ouyi Pharmaceuticals Co. Ltd, China Magnesium Sulphate Injection 1662 50%, per 10ml Injection Promethazine 50mg, per POM Solution for 079/006 CSPC Ouyi Pharmaceuticals Co. Ltd, China Promethazine Injection 1663 2ml Injection Benzyl Penicillin 5000000 POM Powder for 079/007 CSPC Ouyi Pharmaceuticals Co. Ltd, China Benzylpenicillin Injection 1664 IU Injection Ciprofloxacin 250mg POM Tablet Uncoated 079/008 CSPC Ouyi Pharmaceuticals Co. Ltd, China Ciprofloxacin Tablets 1665 Acyclovir 200mg POM Tablet Uncoated 079/009 CSPC Ouyi Pharmaceuticals Co. Ltd, China Acyclovir Tablets 1666 Oxytocin 10 IU, per 10ml POM Solution for 079/010 CSPC Ouyi Pharmaceuticals Co. Ltd, China Oxytocin Injection 1667 Injection Procaine Benzyl Penicillin Procaine Benzyl Penicillin POM Powder for 079/011 CSPC Ouyi Pharmaceuticals Co. Ltd, China 1668 Injection 3000000 IU Injection Atenolol 50mg POM Tablet Uncoated 079/012 CSPC Ouyi Pharmaceuticals Co. Ltd, China Atenolol Tablets 1669 Aminophylline 200mg, POM Solution for 079/013 CSPC Ouyi Pharmaceuticals Co. Ltd, China Aminophylline Injection 1670 per 10ml Injection Penicillin G Benzathine POM Powder for 079/014 CSPC Ouyi Pharmaceuticals Co. Ltd, China Penicillin G Benzathine Injection 1671 2.4000000 IU Injection Dexamethasone Sodium Dexamethasone 8mg, POM Solution for 079/015 CSPC Ouyi Pharmaceuticals Co. Ltd, China 1672 Phosphate Injection per 2ml Injection Artemether 20mg, per ml POM solution for 151/001 Dafra Pharma GmbH, Switzerland Artesian 20 Injection 1673 injection 1674 Artesiane Suppositories Artemether 40 mg POM Suppository 151/002 Dafra Pharma GmbH, Switzerland Artemether 300mg, per POM Suspension 151/003 Dafra Pharma GmbH, Switzerland Artesiane Oral Suspension 1675 100ml Artemether 180mg, per POM Powder for 151/006 Dafra Pharma GmbH, Switzerland Co-Artesian® Powder for Oral 60ml + Lumefantrine Suspension oral Suspension 60ml 1676 1080mg, per 60ml Artemether 360mg, per POM Powder for 151/006 Dafra Pharma GmbH, Switzerland Co-Artesian® Powder for Oral 120ml + Lumefantrine Suspension oral Suspension 120ml 1677 2160mg, per 120ml

Page 87 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Artesunate + POM Tablet Uncoated 151/008 Dafra Pharma GmbH, Switzerland Co-Arinate 100 Tablets Pyrimethamine + 1678 Sulfamethoxypyrazine 1679 Arinate 50 Tablets Artesuate 50mg POM Tablet Uncoated 151/009 Dafra Pharma GmbH, Switzerland 1680 Arinate 100 Tablets Artesuate 100mg POM Tablet Uncoated 151/010 Dafra Pharma GmbH, Switzerland 1681 Artesiane 80 Injection Artemether 80mg, per ml POM Tablet 151/011 Dafra Pharma GmbH, Switzerland Multivitamin P Powder for Oral 151/012 Dafra Pharma GmbH, Switzerland Dafra Vit Powder 1682 Use Bacillus Subtilis PB6 POM Capsule oral 151/015 Dafra Pharma GmbH, Switzerland Aneaban Capsules 1683 complex Amodiaquine + POM Tablet Uncoated 151/016 Dafra Pharma GmbH, Switzerland Amonate FDC Junior Tablets 1684 Artesunate OMega 3 oils POM Syrup 151/018 Dafra Pharma GmbH, Switzerland Fortaline® (Omega-3) Capsules 1685 Diethyl-M-Toluamide GS Solution for Topical 151/019 Dafra Pharma GmbH, Switzerland Pico Stick Insect Repellent 10% + P-Methane-3,8- Use 1686 diol 10% Artemether 100mg, per POM injection 151/020 Dafra Pharma GmbH, Switzerland Artesian 100 Injection 1687 ml 1688 Parol Syrup Paracetamol 250mg GS Syrup 151/021 Dafra Pharma GmbH, Switzerland 1689 Parol Tablets Paracetamol 500mg GS Tablet Uncoated 151/022 Dafra Pharma GmbH, Switzerland 1690 Cipronat 250mg Tablets Ciprofloxacin 250mg POM Tablet Uncoated 151/023 Dafra Pharma GmbH, Switzerland 1691 Cipronat 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 151/024 Dafra Pharma GmbH, Switzerland 1692 Cipronat 700 Tablets Ciprofloxacin 700mg POM Tablet Uncoated 151/025 Dafra Pharma GmbH, Switzerland Amoxicillin 200mg + POM Tablet Uncoated 151/026 Dafra Pharma GmbH, Switzerland Dafraclav 228 Tablets 1693 Clavulanic Acid 28mg Amoxicillin 400mg + POM Suspension for 151/027 Dafra Pharma GmbH, Switzerland Dafraclav Suspension 1694 Clavulanic Acid 57mg Oral Use Amoxicillin 500mg + POM Tablet Uncoated 151/028 Dafra Pharma GmbH, Switzerland Dafraclav 625 Tablets 1695 Clavulanic Acid 125mg Amoxicillin 875mg + POM Tablet Uncoated 151/029 Dafra Pharma GmbH, Switzerland Dafraclav 1000 Tablets 1696 Clavulanic Acid 125mg 1697 Pedifen Tablets Ibuprofen 400mg P Tablet Uncoated 151/030 Dafra Pharma GmbH, Switzerland 1698 Amifer Iron Syrup Iron 40mg, per ml P Syrup 151/031 Dafra Pharma GmbH, Switzerland Artemether 40mg, per ml POM Solution for 151/032 Dafra Pharma GmbH, Switzerland Artesiane 40 Injection 1699 Injection Diethyl-M-Toluamide GS Solution for Topical 151/034 Dafra Pharma GmbH, Switzerland Pico Roll-On Insect Repellant 1700 20% Use

Page 88 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Diethy-M-Toluamide 50% GS Solution for Topical 151/035 Dafra Pharma GmbH, Switzerland Pico Spray 1701 Use Artesunate 100 mg + POM Tablet Uncoated 151/121 Dafra Pharma GmbH, Switzerland Sulfamethoxypyrazine Co-Arinate® Junior 250 mg + Pyrimethamine 1702 12.5 mg Artesunate 200 mg + POM Tablet Uncoated 151/122 Dafra Pharma GmbH, Switzerland Sulfamethoxypyrazine Co-Arinate® Adult 500 mg + Pyrimethamine 1703 25 mg 1704 Loratan 10 Tablets Loratadine 10mg P Tablet Uncoated 322/001 Dar Al Dawa Pharmaceuticals Sildenafil Citrate I.H POM Tablet Uncoated 322/002 Dar Al Dawa Pharmaceuticals Aphrodil - 50 Tablets 1705 50mg Clomiphene Citrate BP POM Tablet Uncoated 322/003 Dar Al Dawa Pharmaceuticals Clomifert Tablets 1706 50mg 1707 Risdone 1mg Tablet Risperidone USP 1mg POM Tablet Uncoated 322/004 Dar Al Dawa Pharmaceuticals 1708 Risdone 2mg Tablets Risperidone USP 2mg POM Tablet Uncoated 322/005 Dar Al Dawa Pharmaceuticals 1709 Diapride 2mg Tablets Glimepiride 2mg POM Tablet Uncoated 322/006 Dar Al Dawa Pharmaceuticals Lignocaine Hydrochloride P Gel Oral 322/007 Dar Al Dawa Pharmaceuticals 3.3mg + Cetylpridinium Dad Teething Gel Chloride 1.0mg 1710 Lidocaine BP 20mg + P Ointment rectal 322/008 Dar Al Dawa Pharmaceuticals Proctoheal New Ointment 1711 Fluocinolone 0.1mg 1712 Mycoheal Oral Gel Miconazole Nitrate 40g POM Gel Oral 322/009 Dar Al Dawa Pharmaceuticals 1713 Loratan Syrup Loratadine 5mg, per 5ml P Syrup 322/010 Dar Al Dawa Pharmaceuticals Ibugesic Cold and Sinus F.C. Ibuprofen Ph Eur 200mg P Tablet Film coated 322/012 Dar Al Dawa Pharmaceuticals Tablets + Pseudoephedrine 1714 Hydrochloride BP 30mg 1715 Liblab Cough Mixture Ivy Leaf Extracts P Syrup 322/011L Dar Al Dawa Pharmaceuticals 1716 Paracetamol 500 Tablets Paracetamol 500mg GS Tablet Uncoated 055/002 Dawa Phamaceuticals Limited, Kenya 1717 Multivitamin Tablets Multivitamins GS Tablet Uncoated 055/003 Dawa Phamaceuticals Limited, Kenya 1718 Eflaron 200 Tablets Metronidazole 200mg POM Tablet Uncoated 055/004 Dawa Phamaceuticals Limited, Kenya Metronidazole 0.5%w/v POM Solution for 055/006 Dawa Phamaceuticals Limited, Kenya Eflaron 0.5 Infusion 1719 infusion Phenoxymethyl Penicillin POM Tablets oral 055/007 Dawa Phamaceuticals Limited, Kenya Penicillin V Tablets 1720 250mg 1721 Fidemycin Capsules Tetracycline 250mg POM Capsule oral 055/010 Dawa Phamaceuticals Limited, Kenya

Page 89 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Kanamycin 1gm POM Powder for 055/011 Dawa Phamaceuticals Limited, Kenya Dawacin Injection 1722 Injection Hyoscine ButylBromide P Tablet Uncoated 055/012 Dawa Phamaceuticals Limited, Kenya Hycin Tablets 1723 10mg Gentamycin 80mg, per POM Solution for 055/013 Dawa Phamaceuticals Limited, Kenya Dawagenta Injection 1724 2ml Injection 1725 Cindomet Capsules Indomethacin 25mg P Capsule oral 055/014 Dawa Phamaceuticals Limited, Kenya Acetyl Salicylic Acid P Tablet Uncoated 055/015 Dawa Phamaceuticals Limited, Kenya Dawasprin Tablets 1726 300mg Amprolium Sulphate POM Powder for Oral 055/017 Dawa Phamaceuticals Limited, Kenya Amidiostat Powder 1727 100g Solution Amodiaquine 65.30mg POM Suspension for 055/018 Dawa Phamaceuticals Limited, Kenya Aphaquine Suspension 1728 Oral Use Sulfadoxine 500mg + P Tablet Uncoated 055/019 Dawa Phamaceuticals Limited, Kenya Fanlar Tablets 1729 Pyrimethamine 25mg Aspirin + Paracetamol + GS Tablet Uncoated 055/020 Dawa Phamaceuticals Limited, Kenya Dawanol Tablets 1730 Caffeine Paracetamol + Caffeine GS Caplets oral 055/021 Dawa Phamaceuticals Limited, Kenya Curamol Plus Caplets 1731 Uncoated Hydrocortisone 100mg POM Powder for 055/022 Dawa Phamaceuticals Limited, Kenya Dawacort Injection 1732 Injection 1733 Vitamin B Tablets B Complex 12mg P Tablet Uncoated 055/023 Dawa Phamaceuticals Limited, Kenya 1734 Dablin Tablets Salbutamol 4mg POM Tablet Uncoated 055/024 Dawa Phamaceuticals Limited, Kenya Nystatin 100,000iu POM Suspension for 055/025 Dawa Phamaceuticals Limited, Kenya Dawastin Suspension 1735 Oral Use Chloramphenicol 1g POM Powder for 055/026 Dawa Phamaceuticals Limited, Kenya Dawaphenicol Injection 1736 Injection 1737 Dawa-CPM Tablets Chlorpheniramine 4mg P Tablet Film coated 055/027 Dawa Phamaceuticals Limited, Kenya 1738 Dawa Ascorbic Acid Tablets Ascorbic Acid 100mg GS Tablet Uncoated 055/028 Dawa Phamaceuticals Limited, Kenya 1739 Rinacet Syrup Cetirizine 5mg P Syrup 055/029 Dawa Phamaceuticals Limited, Kenya Aluminium Hydroxide POM Tablet Chewable 055/030 Dawa Phamaceuticals Limited, Kenya 120mg + Magnesium Stopacid Chewable Tablets Trisilicate 250mg + 1740 Peppermint 0.003ml Silver Sulphadiazine P Cream Topical 055/031 Dawa Phamaceuticals Limited, Kenya Dermazine Cream 1741 1%w/w Ibuprofen 100mg + P Suspension for 055/032 Dawa Phamaceuticals Limited, Kenya Ibupar Suspension 1742 Paracetamol 120mg Oral Use

Page 90 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Diclofenac Diethyl Amine P Gel Topical 055/033 Dawa Phamaceuticals Limited, Kenya 1.16%w/w + Methyl Fast Act Gel Salicylate 10% w/w + Menthol 5% w/w + 1743 Linseed Oil 3% w/w Quinine dihydrochloride POM Suspension for 055/034 Dawa Phamaceuticals Limited, Kenya Topquine Mixture 1744 50mg, per 5ml Oral Use Salbutamol 2mg + P Syrup 055/035 Dawa Phamaceuticals Limited, Kenya Bromohexine Dacough Mucolytic Syrup Hydrochloride 4mg + Guaiphenesin 100mg + 1745 Menthol 1mg Paracetamol 120mg + P Syrup 055/036 Dawa Phamaceuticals Limited, Kenya Dacold Syrup Chlopheniramine 2mg + 1746 Psuedoephedrine 10mg Paracetamol 400mg + P Capsule oral 055/037 Dawa Phamaceuticals Limited, Kenya Cafeine 30mg + Dacold Capsules Psuedoephedrine 30mg 1747 + Chlorpheniramine 4mg Vitamin A 1500 IU + GS Syrup 055/038 Dawa Phamaceuticals Limited, Kenya Dawavite Syrup Thiamine 0.5mg + 1748 Riboflavin 0.5mg Clotrimazole 1.0%w/w + POM Cream Topical 055/039 Dawa Phamaceuticals Limited, Kenya Dazole B Cream Betamethasone 1749 0.1%w/w Benzathine POM Powder for 055/040 Dawa Phamaceuticals Limited, Kenya DAWADUR 2.4 Injection BenzylPenicillin 2.4 Mega Injection 1750 Benzyl Penicillin Sodium POM Powder for 055/041 Dawa Phamaceuticals Limited, Kenya Penicillin G Sodium 5 Injection 1751 BP 5Mega Units Injection Procaine Benzyl Penicillin POM Powder for 055/042 Dawa Phamaceuticals Limited, Kenya Procaine Penicillin Fortified BP 4 Mega Units Injection Injection 1752 Doxycycline POM Capsule oral 055/043 Dawa Phamaceuticals Limited, Kenya Dawadoxyn Capsules Hydrochloride BP 100mg 1753

Page 91 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Miconazole Nitrate POM Cream Topical 055/044 Dawa Phamaceuticals Limited, Kenya 2.0%w/w + Clobetasol Miclocin Cream 0.5%w/w + Gentamicin 1754 0.1%w/w 1755 Topquine Tablets Quinine Sulphate 300mg POM Tablet Film coated 055/045 Dawa Phamaceuticals Limited, Kenya Paracetamol BP 100mg, GS Suspension for 055/046 Dawa Phamaceuticals Limited, Kenya Curamol Suspension 1756 per 5ml Oral Use Paracetamol BP 500mg + GS Caplets oral 055/047 Dawa Phamaceuticals Limited, Kenya Acepar Caplets Aceclofenac BP 100mg Uncoated 1757 Sodium Chloride BP + GS Powder for Oral 055/048 Dawa Phamaceuticals Limited, Kenya Dawalyte Oral Rehydration Salt Potassium Chloride BP + Solution 1758 TriSodium Citrate BP Boric Acid 1.25% + POM Solution for Topical 362/001 DCI Pharmaceuticals Limited Sodium Chloride 0.05% + Use Zinc Sulphate 0.12% + Chlorpheniramine ALLERDROP EYE DROPS Maleate 0.01% + Naphazoline Hydrochloride 0.056% + 1759 Chlorbutol 0.35% Cyanocobalamine POM Solution for 362/002 DCI Pharmaceuticals Limited Cynocob Forte Injection 1760 1000mcg Injection Ranitidine Hydrochloride POM Solution for 362/003 DCI Pharmaceuticals Limited Diciran Injection 1761 25mg, per ml Injection 1762 Dicimycin Eye Drops Chloraphenicol POM Ear Drops 362/004 DCI Pharmaceuticals Limited Betamethasone Soduim POM Solution for Topical 362/005 DCI Pharmaceuticals Limited Betnor Eye/Ear Drop Phosphate BP + Use 1763 Neomycin Sulphate BP 1764 Dicinac Eye Drop Diclofenac BP POM Eye Drops 362/006 DCI Pharmaceuticals Limited Vitamin B Complex POM Solution for 362/007 DCI Pharmaceuticals Limited B-Plus Injection 1765 Injection Tobramycin USP POM Solution for Topical 362/008 DCI Pharmaceuticals Limited Optob Eye Drops 1766 Use

Page 92 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Cyproheptadine P Solution for Oral 067/001 Deltapharm, Egypt Hydrochloride 2mg + Use Thiamine Hydrochloride Deltavit Syrup Appetite 1.2mg + Riboflavin (as 5- Stimulant And General Tonic phosphate) 1.2mg + Pyridoxine Hydrochloride 1.2mg + Nicotinamide 1767 1.2mg 1768 Kids Vitamin Syrup Multivitamins GS Syrup 067/002 Deltapharm, Egypt Diclofenac Sodium POM Suppository 067/003 Deltapharm, Egypt Dolphin 12.5 Suppository 1769 12.5mg Diclofenac Sodium 25mg POM Suppository 067/004 Deltapharm, Egypt Dolphin 25 Suppository 1770 Diclofenac Sodium 75mg POM Suppository 067/005 Deltapharm, Egypt Dolphin 75 Suppository 1771 Nifedipine 10mg POM Tablet Enteric 130/001 Denk Pharma, Germany Nifedi-Denk 10 Retard Tablets 1772 Coated Nifedipine 20mg POM Tablet Enteric 130/002 Denk Pharma, Germany Nifedi-Denk 20 Retard Tablets 1773 Coated Diclofenac 25mg P Tablet Enteric 130/003 Denk Pharma, Germany Diclo-Denk 25 Tablets 1774 Coated 1775 Diclo-Denk 50 Tablets Diclofenac 50mg P Tablet Film coated 130/004 Denk Pharma, Germany Diclofenac 100mg P Tablet Enteric 130/005 Denk Pharma, Germany Diclo-Denk 100 Retard Tablets 1776 Coated Diclofenac 75mg, per 3ml POM Solution for 130/006 Denk Pharma, Germany Diclo-Denk 75mg Injection 1777 Injection Diclofenac Sodium P Suppository 130/007 Denk Pharma, Germany Diclo-Denk 100 Suppositories 1778 100mg Ranitidine Hydrochloride POM Tablet Film coated 130/008 Denk Pharma, Germany Rani-Denk 150 Tablets 1779 150mg Ranitidine Hydrochloride POM Tablet Film coated 130/009 Denk Pharma, Germany Rani-Denk 300 Tablets 1780 300mg 1781 Acyclovir-Denk 200 Tablets Acyclovir 200mg POM Tablet Uncoated 130/010 Denk Pharma, Germany 1782 Acyclovir Denk Cream Acyclovir 5%w/w POM Cream Topical 130/011 Denk Pharma, Germany Clotrimazole 100mg POM Tablet Vaginal 130/012 Denk Pharma, Germany Clotri-Denk 100 Vaginal Tablets 1783 1784 Clotri-Denk 1% Cream Clotrimazole 1% POM Cream Topical 130/013 Denk Pharma, Germany Loperamide POM Tablet Enteric 130/014 Denk Pharma, Germany Loperamide Denk Tablets 1785 Hydrochloride 2mg Coated

Page 93 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 1786 Metformin-Denk 500 Tablets Metformin 500mg POM Tablet Film coated 130/015 Denk Pharma, Germany Etofenamate 100mg, per P Gel Topical 130/016 Denk Pharma, Germany Dolo-Denk Gel 1787 g Paracetamol 125mg P Suppository 130/019 Denk Pharma, Germany Para-Denk 125mg Suppositories 1788 Paracetamol 250mg P Suppository 130/020 Denk Pharma, Germany Para-Denk 250mg Suppositories 1789 1790 Atenolol Denk Tablets Atenolol 50mg POM Tablet Uncoated 130/021 Denk Pharma, Germany Paracetaoml syrup 4mg, P Syrup 130/022 Denk Pharma, Germany Paradenk 4% Syrup 1791 per 100mg 1792 Para-Denk 500 Tablets Paracetamol 500mg P Tablet Uncoated 130/023 Denk Pharma, Germany Captopril/Hydrochlorothiazide Hydrochlorothiazide POM Tablet Uncoated 130/024 Denk Pharma, Germany 1793 Tablets 50mg + Captopril 25mg 1794 Furodenk 40 Tablets Frusemide 40mg POM Tablet Uncoated 130/025 Denk Pharma, Germany 1795 Vera-Denk 240 Retard Tablets Verapamil 240mg POM Tablet Uncoated 130/026 Denk Pharma, Germany 1796 Famotidine Denk Tablets Famotidine 40mg POM Tablet Film coated 130/027 Denk Pharma, Germany 1797 Amoxi-Denk 500 Tablets Amoxicillin 500mg POM Tablet Uncoated 130/028 Denk Pharma, Germany 1798 Cipro-Denk Tablets Ciprofloxacin 500mg POM Tablet Film coated 130/029 Denk Pharma, Germany 1799 Ibuprofen Denk 400 Tablets Ibuprofen 400mg P Tablets oral 130/030 Denk Pharma, Germany Pyrimethamine 12.5mg + POM Tablet Uncoated 130/032 Denk Pharma, Germany Sulphamethoxypyrazine Asunate Denk 100 Plus Tablets 250mg + Artesuate 100mg 1800 1801 Asunate Denk 200 Tablets Artesunate 200mg POM Tablet Uncoated 130/033 Denk Pharma, Germany Pyridoxine 200mg + POM Tablet Uncoated 130/034 Denk Pharma, Germany Vit-B-Denk Tablets 1802 Thiamine 100mg Beta Artemether 180mg , POM Suspension for 130/035 Denk Pharma, Germany Armether Denk 180 Suspension 1803 per 100ml Oral Use 1804 Simva-Denk 40mg Tablets Simvastatin 40mg POM Tablet Uncoated 130/039 Denk Pharma, Germany 1805 Simva-Denk 20mg Tablets Simvastatin 20mg POM Tablet Uncoated 130/040 Denk Pharma, Germany 1806 Amilo-Denk 5mg Tablets Amlodipine 5mg POM Tablet Uncoated 130/041 Denk Pharma, Germany 1807 Amilo-Denk 10mg Tablets Amlodipine 10mg POM Tablet Uncoated 130/042 Denk Pharma, Germany 1808 Ena-Denk 10mg Tablets Enalapril 10mg POM Tablet Uncoated 130/043 Denk Pharma, Germany 1809 Ena-Denk 20mg Tablets Enalapril 20mg POM Tablet Uncoated 130/044 Denk Pharma, Germany 1810 Toras-Denk 5mg Tablets Torasemide 5mg POM Tablet Uncoated 130/046 Denk Pharma, Germany 1811 Toras Denk 10 Tablets Torasemide 10mg POM Tablet Uncoated 130/047 Denk Pharma, Germany 1812 Amether-Denk Suppocap Artemether 40mg POM Suppository 130/048 Denk Pharma, Germany

Page 94 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Paracetamol 500mg + P Tablet Uncoated 130/049 Denk Pharma, Germany Paraco-Denk 500/30mg Tablets 1813 Codeine 30mg Paracetamol 1000mg + P Suppository 130/050 Denk Pharma, Germany Paraco-Denk1000/60mg Tablets 1814 Codeine 60mg Artesunate 200mg + POM Tablet Uncoated 130/052 Denk Pharma, Germany Sulfamethoxypyrazine Asu -Denk Fixed Dose Tablets 500mg + Pyrimethamine 1815 25mg Losartan 50mg POM Tablet Enteric 130/053 Denk Pharma, Germany Losar Denk 50 Tablets 1816 Coated Losartan 100mg POM Tablet Enteric 130/054 Denk Pharma, Germany Losar - Denk 100 Tablets 1817 Coated Lorsartan 50mg + POM Tablet Uncoated 130/055 Denk Pharma, Germany Colosar -Denk 50/12.5mg Hydrochlorothiazide Tablets 1818 12.5mg 1819 Metformin Denk 1000 Tablets Merformin 1000mg POM Tablet Uncoated 130/056 Denk Pharma, Germany 1820 Glimepride Denk Tablets Glimepiride 2mg POM Tablet Uncoated 130/058 Denk Pharma, Germany 1821 Flucona-Denk 100 Capsules Fluconazole 100mg POM Capsule oral 130/060 Denk Pharma, Germany 1822 Flucona -Denk 150 Capsules Fluconazole 150mg POM Capsule oral 130/061 Denk Pharma, Germany Amoxicillin Trihydrate POM Tablet Uncoated 130/062 Denk Pharma, Germany Amoxicalv -Denk 500/62.5 500mg + Clavulanic Acid Tablets 1823 62.5mg Tramadol Hydrochloride P Tablet Uncoated 130/063 Denk Pharma, Germany Tramadol Denk 50 Tablets 1824 50mg Zoledronic Acid POM Solution for 130/064 Denk Pharma, Germany Zolendro - Denk Injection anhydrous BP 4mg, per Injection 1825 5ml Granisetron POM Solution for 130/065 Denk Pharma, Germany Grani - Denk Inject Hydrochloride USP 1mg, infusion 1826 per ml 1827 Clopi-Denk 75 Tablets Clopidogrel 75mg POM Tablet Uncoated 130/066 Denk Pharma, Germany 1828 Ibuprofen Denk 600mg Tablets Ibuprofen 600mg POM Tablet Film coated 130/067 Denk Pharma, Germany Lorsartan Potassium POM Tablet Uncoated 130/068 Denk Pharma, Germany Eur.Ph 100mg + Colosar - Denk100/12.5 Tablets Hydrochlorothiazide 1829 Eur.Ph 12.5mg 1830 Anastrazole Denk 1 Tablets Anastrozole 1mg POM Tablet Uncoated 130/069 Denk Pharma, Germany Lorsatan Potassium POM Tablet Uncoated 130/070 Denk Pharma, Germany Losar-Denk 25 Tablets 1831 25mg

Page 95 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Levofloxacin POM Tablet Uncoated 130/071 Denk Pharma, Germany Levo- Denk 500 Tablets 1832 Hemihydrate 500mg Pantoprazole Sodium BP POM Tablet Uncoated 130/072 Denk Pharma, Germany Panto-Denk 40 Tablets 1833 40mg Pantoprazole Sodium BP POM Tablet Uncoated 130/073 Denk Pharma, Germany Panto-Denk 20 Tablets 1834 40mg Levofloxacin POM Tablet Uncoated 130/074 Denk Pharma, Germany Levo Denk -250 Tablets 1835 Hemihydrate 250mg Amoxiclav-Denk 1000/125 Amoxicillin 1000mg+ POM Tablet Uncoated 130/075 Denk Pharma, Germany 1836 Tablets Clavulanic Acid 125mg 1837 Valsar-Denk 320 Tablets Valsartan 320mg POM Tablet Film coated 130/076 Denk Pharma, Germany 1838 Valsr- Denk 80 Tablets Valsartan 80mg POM Tablet Film coated 130/077 Denk Pharma, Germany Magnesium 300 mg P Powder for Oral 130/078 Denk Pharma, Germany Magnes Active Powder 1839 Solution Calcium 500 mg P Tablet, 130/079 Denk Pharma, Germany Calcium Active Denk Tablets 1840 Effervescent Selenium, Zinc, Folic P Powder for Oral 130/080 Denk Pharma, Germany Acid, Vitamin E, L- Solution Fertilio Denk Tablets arginine, L-carnitine and 1841 Coenzyme Q10 Iron 15 mg + Folic Acid P Tablet Uncoated 130/081 Denk Pharma, Germany Ferro Vital+Denk CW 400 µg + Vitamin C 1842 30mg Magnesium Hydroxide P Powder for Oral 130/083 Denk Pharma, Germany Magnes Direct Denk Sachets 1843 400mg Solution Folic Acid 800 µg, all B- P Tablet Uncoated 130/084 Denk Pharma, Germany Prenatal Denk vitamins and Iodine 150 1844 µg 1845 Valsar-Denk 160 Tablets Valsartan 160mg POM Tablet Uncoated 130/085 Denk Pharma, Germany 1846 Valsar- Denk 40 Tablets Valsartan 40mg POM Tablet Uncoated 130/086 Denk Pharma, Germany Valsartan 320mg + POM Tablet Uncoated 130/087 Denk Pharma, Germany Covalsar-Denk Hydrochlorothiazide 1847 12.5mg Valsartan 160mg + POM Tablet Uncoated 130/088 Denk Pharma, Germany Covalsar-Denk Hydrochlorothiazide 1848 12.5mg 1849 Metformin Denk 850 Tablets Metformin 850mg POM Tablets oral 130/131 Denk Pharma, Germany

Page 96 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Timodor Eye Drops Dorzolamide HCLL POM Ear/Eye Drops 447/001 Diamond pharma 20mg/ml + Timolol 1850 Maleate 5mg/ml 1851 Mycoten® Cream Clotrimazole BP 1% 20g P topical cream 399/002 Drug International Limited Gentamycin BP 1.0mg + POM topical cream 399/001 Drugfield Pharmaceuticals Ltd Dexamethasone BP Biocoten® Cream 0.4mg + Chlotrimazole 1852 BP 10.0mg Neurogesic® Greaseless Methylsalicylate BP GS topical ointment 399/003 Drugfield Pharmaceuticals Ltd 1853 Ointment 15% + Menthol BP 5% Chlorhexidine GS topical gel 399/004 Drugfield Pharmaceuticals Ltd Chlorxy-G Gel 1854 Digluconate 7.1% 1855 Goat's Milk Tablets Goat Milk 250mg P Tablet Uncoated 031/001L Dynapharm International (Zambia) Limited 1856 Di Sprulina Tablets Sprulina 300mg P Tablet Uncoated 031/002L Dynapharm International (Zambia) Limited Ginkgoo Biloba Extract P Tablet Uncoated 031/003L Dynapharm International (Zambia) Limited Yeeginkgo Tablets 1857 40mg Tongkat Ali Extract P Capsule oral 031/004L Dynapharm International (Zambia) Limited Tongkat Ali Tablets 1858 100mg Di Liquid Chlorophyll Plus Herbal Extracts P Solution for Oral 031/005L Dynapharm International (Zambia) Limited 1859 Guarana Solution Use 1860 Dyna Tonic Syrup Herbal Extracts P Syrup 031/006L Dynapharm International (Zambia) Limited 1861 Bee Pollen Capsule Bee Pollen 450mg P Capsule oral 031/007L Dynapharm International (Zambia) Limited 1862 Dyna Rh Capsules D-glucosamine 250mg P Capsule oral 031/008L Dynapharm International (Zambia) Limited 1863 Ginseng Capsules Ginseng Powder 300mg P Capsule oral 031/009L Dynapharm International (Zambia) Limited 1864 Yeegarlic Capsules Garlic 160mg P Capsule oral 031/010L Dynapharm International (Zambia) Limited Grape Seed Dry Extract P Tablet Uncoated 031/011L Dynapharm International (Zambia) Limited Yeeyangyen Tablets 1865 50mg 1866 Dyna C 250 Tablets Ascobic Acid 250mg P Tablet Uncoated 031/012L Dynapharm International (Zambia) Limited 1867 Mancare Plus Capsules Herbal Extracts P Capsule oral 031/013L Dynapharm International (Zambia) Limited Vit A 2000IU + Vit D P Syrup 031/014 Dynapharm International (Zambia) Limited 400IU + Vit B2 1.5mg + Vit B6 1.0mg + Vit B12 Daily-Vite Multivitamin Syrup 3.0mcg + Niacinamide 10mg + Vit C 50mg + L- 1868 37.5mg 1869 Herba Warisani Maharani Herbal Preparation P Tablet Film coated 031/014L Dynapharm International (Zambia) Limited 1870 Dyanil Tablets Glibenclamide 5mg POM Tablet Uncoated 031/015 Dynapharm International (Zambia) Limited 1871 Dyna Calcium Tablets Calcium Lactate 39mg P Tablet Uncoated 031/016 Dynapharm International (Zambia) Limited 1872 Metformin Tablets Metformin 500mg POM Tablet Uncoated 031/017 Dynapharm International (Zambia) Limited

Page 97 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Silybum marianum P Tablet Uncoated 031/018L Dynapharm International (Zambia) Limited Milk Thistle Tablets 1873 100mg 1874 Amoxicillin Capsules 250mg Amoxicillin 250mg POM Capsule oral 031/019 Dynapharm International (Zambia) Limited 1875 Amoxicillin Capsules 500mg Amoxicillin 500mg POM Capsule oral 031/020 Dynapharm International (Zambia) Limited 1876 Cloxacillin Capsules 250mg Cloxacillin 250mg POM Capsule oral 031/021 Dynapharm International (Zambia) Limited 1877 Dynafucin 500 Tablet Griseofulvin 500mg POM Tablet Uncoated 031/022 Dynapharm International (Zambia) Limited 1878 Doxycycline Capsule 100mg Doxycycline 100mg POM Capsule oral 031/023 Dynapharm International (Zambia) Limited 1879 Dynidazole Tablet 200mg Metronidazole 200mg POM Tablet Uncoated 031/024 Dynapharm International (Zambia) Limited 1880 Lomodium Tablets 2mg Loperamide 2mg POM Tablet Uncoated 031/025 Dynapharm International (Zambia) Limited 1881 Prednisolone Tablet Prednisolone 5mg POM Tablet Uncoated 031/026 Dynapharm International (Zambia) Limited 1882 PRO- LSB Tablets Probiotics P Tablet Uncoated 031/027 Dynapharm International (Zambia) Limited 1883 Dyna Serenoa Tablets Serenoa repens 80mg P Tablet Uncoated 031/028L Dynapharm International (Zambia) Limited 1884 Dyna S Tablets Herbal Preparation P Tablet Uncoated 031/029L Dynapharm International (Zambia) Limited 1885 Sea Cucamber Plus Syrup Herbal Preparation P Syrup 031/030L Dynapharm International (Zambia) Limited 1886 Green Tea Extract Capsules Herbal Preparation P Capsule oral 031/031L Dynapharm International (Zambia) Limited Betamethasone POM Lotion for Topical 075/031 Dynapharm International (Zambia) Limited Diproson Lotion 1887 0.05%w/w Use Ginseng Powder 1.5% GS Granules for Oral 312/001L Edmark International (Z) Ltd,Malaysia Edmark Ginseng Coffee 1888 per Sachet Use Edmark Splina Liquid Chlorophyll 4 gms P Solution for Oral 312/002L Edmark International (Z) Ltd,Malaysia 1889 Chlorophyll Drink Use Isolated Soya Protein GS Powder for Oral 312/003L Edmark International (Z) Ltd,Malaysia Edmark MRT Complex 39.83% + Low Fat Milk Suspension Chocolate Drink 1890 29.9% + L-Carnit 1.82% Red Yeast Rice Powder P Granules for Oral 312/004L Edmark International (Z) Ltd,Malaysia Edmark Red Yeast Coffee 1891 1.5% Use Instant Oat 45% + P Granules for Oral 312/005L Edmark International (Z) Ltd,Malaysia Edmark Shake Off Psyllium Husk 19.5% + Use 1892 Inulin 2% Diethyl Carbamazine POM Tablet Film coated 348/001 Eisai Pharmatechnology & Manufacturing DEC Tablets 1893 Citrate 100mg Pvt. Ltd Calcium 250mg + Vitamin P Tablet Uncoated 285/001 Elder Pharmaceuticals Ltd, India Shelcal-250 Tablets 1894 D3 125iu 1895 Alonurish Acne Gel Herbal Extracts GS Gel Topical 285/001HM Elder Pharmaceuticals Ltd, India Triclosan 0.03% + GS Solution for Oral 285/002HM Elder Pharmaceuticals Ltd, India Sodium Benzoate 2% + Use A.M. P.M. Plus Dental Rinse Sodium Fluoride 0.05% 1896 w/v + Alcohol 1897 Venex 300 Tablets Diosmin 300mg POM Tablet Uncoated 285/003 Elder Pharmaceuticals Ltd, India

Page 98 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 1898 Alonurish Moisturising Cream Herbal extracts GS Cream Topical 285/003HM Elder Pharmaceuticals Ltd, India 1899 Venex 500 Tablets Diosmin 500mg POM Tablet Uncoated 285/004 Elder Pharmaceuticals Ltd, India Herbal Extracts GS Solution for Topical 285/004HM Elder Pharmaceuticals Ltd, India Alonurish Scalp Cleanser 1900 Use Conjugated Oestrogen POM Tablet Film coated 285/005 Elder Pharmaceuticals Ltd, India Conjugate 0.625 Tablets 1901 0.625mg Triclosan 0.03%+ Sodium GS Solution for Oral 285/005HM Elder Pharmaceuticals Ltd, India A.M. P.M. Plus Junior Dental Benzoate 0.05% + Use Rinse Sodium Fluoride + 1902 Alcohol Calcium 500mg + Vitamin P Tablet Uncoated 285/006 Elder Pharmaceuticals Ltd, India Shelcal-500 Tablets 1903 D3 125IU 1904 Alonurish Alnite Cream Herbal Extracts P Cream Topical 285/006HM Elder Pharmaceuticals Ltd, India Medroxyprogesterone POM Tablet Uncoated 285/007 Elder Pharmaceuticals Ltd, India Deviry 10 Tablets 1905 10mg Herbal Extracts P Lotion for Topical 285/007HM Elder Pharmaceuticals Ltd, India Alonurish Sunscreen Lotion 1906 Use 1907 Edge 400 Capsules Vitamin E 400IU POM Capsule oral 285/008 Elder Pharmaceuticals Ltd, India Herbal Extracts GS Solution for Topical 285/008HM Elder Pharmaceuticals Ltd, India Alonurish Face Cleanser 1908 Use Ambroxol 15mg + POM Syrup 285/009 Elder Pharmaceuticals Ltd, India Terbutaline 1.2mg + New Zephrol Syrup Guaiphenesin 50mg + 1909 Menthol 2.5mg Triclosan 0.03%w/v + GS Solution for Oral 285/009HM Elder Pharmaceuticals Ltd, India Sodium Benzoate Use A.M. P.M. Special Dental Rinse 2.0%w/v + Sodium Fluoride 0.05%w/v + 1910 Thymol 0.2%w/v 1911 Tiger Balm White Ointment Herbal Extracts GS Ointment topical 285/010HM Elder Pharmaceuticals Ltd, India Calcium 250mg + Vitamin P Syrup 285/011 Elder Pharmaceuticals Ltd, India Shelcal Syrup 1912 D3 125IU 1913 Mucodyne Syrup Carbocisteine 260mg P Syrup 285/011HM Elder Pharmaceuticals Ltd, India Proteolytic Enzyme POM Tablet Uncoated 285/012 Elder Pharmaceuticals Ltd, India Chymoral Forte Tablets Eoncentrate 100,000 I.U. 1914 1915 Solo Cough Syrup Herbal extracts 605mg P Syrup 285/012HM Elder Pharmaceuticals Ltd, India 1916 Eldervit Capsules Vitamins 349.5mg P Capsule oral 285/013 Elder Pharmaceuticals Ltd, India 1917 Jetmox - 250 Capsules Amoxicillin 250mg POM Capsule oral 285/014 Elder Pharmaceuticals Ltd, India

Page 99 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Furosemide 40mg + POM Tablet Uncoated 285/015 Elder Pharmaceuticals Ltd, India Amifru-40 Tablets Amiloride Hydrochoride 1918 5mg Hormorin Soft Gel Capsules Progesterone 200mg POM Capsule oral 285/016 Elder Pharmaceuticals Ltd, India 1919 200mg Aceclofenac 100mg + P Tablet Film coated 285/017 Elder Pharmaceuticals Ltd, India Xtra-P Tablets 1920 Paracetamol 500mg Vitamin C 150mg + POM Solution for 285/018 Elder Pharmaceuticals Ltd, India Vitamin B12 2500mcg + infusion Elder Vit -12 Injection Folic Acid 0.7mg + 1921 Niacinamide 1.2mg 1922 Carnisure-500 Tablets Levocarnitine 500mg POM Tablet Uncoated 285/019 Elder Pharmaceuticals Ltd, India 1923 Powertad 20 Tablets Tadalafil 20mg POM Tablet Uncoated 285/020 Elder Pharmaceuticals Ltd, India 1924 Powertad 10 Tablets Tadalafil 10mg POM Tablet Uncoated 285/021 Elder Pharmaceuticals Ltd, India 1925 Clair 500mg Tablets Clarithromycin 500mg POM Tablet Uncoated 285/022 Elder Pharmaceuticals Ltd, India 1926 Clair 250mg Tablets Clarithromycin 250mg POM Tablet Uncoated 285/023 Elder Pharmaceuticals Ltd, India Aspirin 75mg POM Tablet Enteric 285/024 Elder Pharmaceuticals Ltd, India Eprin -75 Tablets 1927 Coated 1928 Vitessen C Tablets Ascorbic Acid 500mg P Tablet Chewable 285/025 Elder Pharmaceuticals Ltd, India 1929 Antizip Capsules Nizatidine 150mg POM Capsule oral 174/001 Eli Lilly (SA) Pty Ltd Fluoxetine Hdyrochloride POM Tablet Uncoated 174/002 Eli Lilly (SA) Pty Ltd Prozac Tablets 1930 EurP 20mg 1931 Lilly-Cefador Tablets Cefaclor 375mg POM Tablet Uncoated 174/003 Eli Lilly (SA) Pty Ltd Cefaclor 375mg, per 5ml POM Powder for Oral 174/004 Eli Lilly (SA) Pty Ltd Lilly-Cefaclor Suspension 1932 Suspension Cefaclor Monohydrate POM Suspension 174/005 Eli Lilly (SA) Pty Ltd Lilly Cefaclor Granules 1933 USP 187mg, per ml Aluminium Hydrochloride GS Suspension for 188/001 Elys Chemicals Industries Ltd, Kenya Alugel Suspension 120mg + Magnesium Oral Use 1934 Trisilicate 250mg 1935 Ampicillin Capsules Ampicillin 250mg POM Capsule oral 188/002 Elys Chemicals Industries Ltd, Kenya Hyoscine Butyl Bromide POM Tablet Uncoated 188/003 Elys Chemicals Industries Ltd, Kenya Bukol Tablets 1936 10mg Glycyrrhiza + Menthol + GS Syrup 188/004 Elys Chemicals Industries Ltd, Kenya Aniseed oil + Peppermint Chestcof Syrup oil + Ipecacuanha + Capsicum 1937

Page 100 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Ampicillin 250mg + POM Capsule oral 188/005 Elys Chemicals Industries Ltd, Kenya Elyclox Capsules 1938 Cloxacillin 250mg 1939 Elymox Capsules Amoxicillin POM Capsule oral 188/006 Elys Chemicals Industries Ltd, Kenya 1940 Elyvate Ointment Betamethasone 0.5% POM Ointment topical 188/007 Elys Chemicals Industries Ltd, Kenya 1941 Elyvate Cream Betamethasone 0.5% POM Cream Topical 188/008 Elys Chemicals Industries Ltd, Kenya 1942 Fungistin Vaginal Tablets Nystatin 1000000IU POM Tablet Vaginal 188/009 Elys Chemicals Industries Ltd, Kenya Acetyl Salicylic Acid GS Tablet Uncoated 188/010 Elys Chemicals Industries Ltd, Kenya Junior Aspirin Tablets 1943 80mg 1944 Nitrofurantoin Tablets Nitrofurantoin 100mg POM Tablet Uncoated 188/011 Elys Chemicals Industries Ltd, Kenya Sulfadoxine 500mg + P Tablet Uncoated 188/012 Elys Chemicals Industries Ltd, Kenya Orodar Tablets 1945 Pyrimethamine 25mg 1946 Promethazine Tablets Promethazine 25mg P Tablet Uncoated 188/013 Elys Chemicals Industries Ltd, Kenya 1947 Quinine Tablets Quinine Sulphate 300mg POM Tablet Film coated 188/014 Elys Chemicals Industries Ltd, Kenya 1948 Elycort Ointment Hydrocortisone 0.1g POM Ointment Topical 188/015 Elys Chemicals Industries Ltd, Kenya Amoxicillin 125mg, per POM Suspension for 188/016 Elys Chemicals Industries Ltd, Kenya Elymox Powder 1949 5ml Oral Use Cloxacillin Powder For Cloxacillin 125mg, per POM Suspension for 188/017 Elys Chemicals Industries Ltd, Kenya 1950 Suspension 5ml Oral Use Ampicillin 125mg, per POM Suspension for 188/018 Elys Chemicals Industries Ltd, Kenya Ampicillin Powder 1951 5ml Oral Use Phenoxymethyl Penicillin POM Tablet Uncoated 188/019 Elys Chemicals Industries Ltd, Kenya Elypen Tablets 1952 V 250mg Salicylic Acid + Benzoic P Ointment topical 188/020 Elys Chemicals Industries Ltd, Kenya Whitefield Ointment 1953 Acid Sodium Chloride + GS Powder for Oral 188/021 Elys Chemicals Industries Ltd, Kenya Sodium Citrate + Solution Lyte Oral Rehydration Salt Patassium Chloride + 1954 Glucose 1955 Wormol Tablets Mebendazole 100mg P Tablet Uncoated 188/022 Elys Chemicals Industries Ltd, Kenya Vit A + Thiamine + P Syrup 188/023 Elys Chemicals Industries Ltd, Kenya Riboflavin + Nicotinamide Elydac Syrup + Vit C + Vit D3 1956 1957 Frusemide Tablets Frusemide 40mg POM Tablet Uncoated 188/024 Elys Chemicals Industries Ltd, Kenya

Page 101 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Chlorpheniramine 1mg + P Syrup 188/025 Elys Chemicals Industries Ltd, Kenya Diphenhydramine 5mg + Promethazine 2.5mg + Tripacof Syrup Ephedrine 7.5mg + Ammonium Chloride 1958 40mg 1959 Vulmtrex Tablets Levamisole 40mg P Tablet Uncoated 188/026 Elys Chemicals Industries Ltd, Kenya Levamisole 40mg, per P Suspension for 188/027 Elys Chemicals Industries Ltd, Kenya Vumtrex Suspension 1960 5ml Oral Use Aspirin 350mg BP + GS Tablet Uncoated 188/028 Elys Chemicals Industries Ltd, Kenya Mifupen Tablets 1961 Caffeine 30mg BP Glycyrrhiza + Menthol + GS Lozenges 188/029 Elys Chemicals Industries Ltd, Kenya Chestcof Lozenges Aniseed oil + Peppermint 1962 oil 1963 Antihistamin Cream Mepyramine 0.306 gm P Cream Topical 188/030 Elys Chemicals Industries Ltd, Kenya 1964 Elytetra Ointment Tetracycline 0.495gm POM Cream Topical 188/031 Elys Chemicals Industries Ltd, Kenya 1965 Ibufen Tablets Ibuprofen 200mg P Tablet Uncoated 188/032 Elys Chemicals Industries Ltd, Kenya Multivitamins GS Tablet Enteric 188/033 Elys Chemicals Industries Ltd, Kenya Multivitamin Tablets 1966 Coated 1967 Elytetra Capsules Tetracycline 250MG POM Capsule oral 188/034 Elys Chemicals Industries Ltd, Kenya 1968 Doxycycline Caps Doxycycline 100mg POM Capsule oral 188/035 Elys Chemicals Industries Ltd, Kenya 1969 Sulphur Ointment Sulphur 2g P Cream Topical 188/036 Elys Chemicals Industries Ltd, Kenya 1970 Fungistat Cream Miconazole 0.3%w/v POM Cream Topical 188/037 Elys Chemicals Industries Ltd, Kenya 1971 Elocin Tablets Erythromycin 250mg POM Tablet Uncoated 188/038 Elys Chemicals Industries Ltd, Kenya Himani Fast Relief Herbal Pain Herbal Extracts GS Ointment topical 369/001L Emami Limited, India 1972 Relief Ointment Himani Fast Relief Herbal Pain Herbal Extracts GS Ointment topical 369/002L Emami Limited, India 1973 Balm Himani Boroplus Antiseptic Herbal Extracts GS Cream Topical 369/003L Emami Limited, India 1974 Cream Herbal Extracts GS Lotion for Topical 369/004L Emami Limited, India Emami Mentho Plus Balm 1975 Use Himani Fast Relief Herbal Pain Herbal Extracts GS Spray for Topical 369/005L Emami Limited, India 1976 Relief Spray Use Himani Fast Relief Herbal Herbal Extracts GS Ointment topical 369/006L Emami Limited, India 1977 Vapour Rub 1978 Rosiz 4 Tablets Rosiglitazone 4mg POM Tablet Film coated 125/040 Emcure Pharmaceuticals Limited, India Amoxicillin + Clavulanate POM Tablet Film coated 195/001 Emcure Pharmaceuticals Limited, India Augpen 375 Tablets 1979 Potassium 375mg

Page 102 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Amoxicillin + Clavulanate POM Tablet Film coated 195/002 Emcure Pharmaceuticals Limited, India Augpen 625 Tablets 1980 Potassium 625mg 1981 Ciprobiotic Eye/Ear Drops Ciprofloxacin 3mg POM Ear/Eye Drops 195/003 Emcure Pharmaceuticals Limited, India 1982 Zeflox Eye/Ear Drops Norfloxacin 15mg POM Ear/Eye Drops 195/004 Emcure Pharmaceuticals Limited, India 1983 Diclomove NDS Gel Diclofenac 1%w/w P Gel Topical 195/005 Emcure Pharmaceuticals Limited, India Ceftriaxone 1g POM Powder for 195/006 Emcure Pharmaceuticals Limited, India C-Tri Injection 1984 Injection 1985 Orofer Chewable Tablets Folic Acid + Iron P Tablet Film coated 195/008 Emcure Pharmaceuticals Limited, India 1986 Nusar 50 Tablets Losartan 50mg POM Tablet Film coated 195/010 Emcure Pharmaceuticals Limited, India Ferric oxide 50mg P Solution for Oral 195/011 Emcure Pharmaceuticals Limited, India Orofer Drops 1987 Use Lamivudine 200mg + POM Tablet Uncoated 195/012 Emcure Pharmaceuticals Limited, India Emtri Tablets Nevirapine 150mg + 1988 Stavudine 40mg Ciprofloxacin 0.5%w/w + POM Cream Topical 195/014 Emcure Pharmaceuticals Limited, India Ciprobiotic FC Cream Clotrimazole + 1989 Fluocinolone Acetonide 1990 Zosec Capsules Omeprazole 20mg POM Capsule oral 195/015 Emcure Pharmaceuticals Limited, India 1991 Ciprobiotic Forte Tablets Ciprofloxacin 500mg POM Tablet Film coated 195/017 Emcure Pharmaceuticals Limited, India Amoxicillin Trihydrate POM Suspension for 195/018 Emcure Pharmaceuticals Limited, India Agupen Suspension 500mg + Clavulanic Acid Oral Use 1992 125mg Cyanocobalamin 5mcg + P Syrup 195/019 Emcure Pharmaceuticals Limited, India Orofer Syrup 1993 Elemental Iron 50mg 1994 Orofer Cap Folic Acid + Iron P Capsule Oral 195/020 Emcure Pharmaceuticals Limited, India 1995 Orofer Capsules Folic Acid + Iron P Capsule oral 195/021 Emcure Pharmaceuticals Limited, India Clioquinol BP + POM Cream Topical 195/022 Emcure Pharmaceuticals Limited, India Beclasone C Cream 1996 Beclomethasone BP 15g Salbutamol 1mg + P Syrup 195/024 Emcure Pharmaceuticals Limited, India Bromhexine 2mg + Vifex Syrup Guaiphenesin 50mg + 1997 Menthol 0.5mg Colecalciferol 500mg + P Tablet Uncoated 195/026 Emcure Pharmaceuticals Limited, India Caloshel Tablets 1998 Elemental Calcium 1999 C-Tax 200 Tablets Cefixime 200mg POM Tablet Film coated 195/028 Emcure Pharmaceuticals Limited, India Cefixime 50mg POM Suspension for 195/029 Emcure Pharmaceuticals Limited, India C-Tax P 50 Dry Syrup 2000 Oral Use 2001 Atorec 10 Tablets Atorvastatin 10mg POM Tablet Film coated 195/030 Emcure Pharmaceuticals Limited, India 2002 Atorec 20 Tablets Atorvastatin 20mg POM Tablet Film coated 195/031 Emcure Pharmaceuticals Limited, India

Page 103 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 2003 Acem-500mg Clarithromycin 500mg POM Tablet Uncoated 195/033 Emcure Pharmaceuticals Limited, India 2004 Asomex-2.5 Tablets Amlodipine 2.5mg POM Tablet Uncoated 195/034 Emcure Pharmaceuticals Limited, India 2005 Asomex- 5 Tablets Amlodipine 5mg POM Tablet Uncoated 195/035 Emcure Pharmaceuticals Limited, India Losartan + POM Tablets Oral 195/036 Emcure Pharmaceuticals Limited, India Nusar H Tablets 2006 Hydrochlorothiazide 2007 Sylate 500 Tablets Etamsylate 500mg POM Tablet Uncoated 195/038 Emcure Pharmaceuticals Limited, India 2008 Rosiz 2 Tablets Rosiglitazone 2mg POM Tablet Film coated 195/039 Emcure Pharmaceuticals Limited, India 2009 Diclomove SR Tablets Diclofenac POM Tablet Uncoated 195/041 Emcure Pharmaceuticals Limited, India 2010 Dinor Tablets Didanosine 100mg POM Tablet Chewable 195/042 Emcure Pharmaceuticals Limited, India 2011 Lamir -150 Tablets Lamivudine 150mg POM Tablet Film coated 195/043 Emcure Pharmaceuticals Limited, India 2012 Zidine Capsules Zidovudine 100mg POM Capsule oral 195/044 Emcure Pharmaceuticals Limited, India 2013 Stadine - 40 Capsules Stavudine 40mg POM Capsule oral 195/045 Emcure Pharmaceuticals Limited, India 2014 Efcure Tablets Efavirenz 600mg POM Tablet Uncoated 195/046 Emcure Pharmaceuticals Limited, India Lamivudine 150mg + POM Tablet Uncoated 195/047 Emcure Pharmaceuticals Limited, India Emduo-40 Tablets 2015 Stavudine 40mg 2016 Zidine Tablets Zidovudine 300mg POM Tablet Uncoated 195/048 Emcure Pharmaceuticals Limited, India Zidovudine 50mg, per POM Solution for Oral 195/049 Emcure Pharmaceuticals Limited, India Zidine Oral Solution 2017 5ml Use Stavudine 10mg + POM Suspension for 195/051 Emcure Pharmaceuticals Limited, India Emtri Suspension Lamivudine 40mg + Oral Use 2018 Nevirapine 70mg Alpha-Recombinant POM Solution for 195/052 Emcure Pharmaceuticals Limited, India Vintor Injection Human Erythropoietin Injection 2019 2000IU Lamivudine 40mg + POM Tablet Uncoated 195/053 Emcure Pharmaceuticals Limited, India Emtri Junior Tablets Stavudine 10mg + 2020 Nevirapine 70mg Ferric Hydroxide complex POM Solution for 195/054 Emcure Pharmaceuticals Limited, India Encifer Injection 2021 2g, per ml Injection 2022 Metpure-XL S-(-) Metoprolol 25mg POM Tablet Uncoated 195/056 Emcure Pharmaceuticals Limited, India 2023 Metpure-XL S-(-) Metoprolol 50mg POM Tablet Uncoated 195/057 Emcure Pharmaceuticals Limited, India 2024 Panpure Tablets S-Pantoprazole 20mg POM Tablet Uncoated 195/058 Emcure Pharmaceuticals Limited, India 2025 Ibusoft 300 Dexibuprofen 300mg P Tablet Film coated 195/059 Emcure Pharmaceuticals Limited, India 2026 Ibusoft 400 Dexibuprofen 400mg P Tablet Film coated 195/060 Emcure Pharmaceuticals Limited, India Lomoh-40 (Low Molecular Enoxaparin 40mg POM Solution for 195/061 Emcure Pharmaceuticals Limited, India 2027 Weight Heparin) Injection Injection Lomoh -60 (Low Molecular Enoxaparin 60mg POM Solution for 195/062 Emcure Pharmaceuticals Limited, India 2028 Weight Heparin) Injection Injection 2029 MOFILET - 500 Tablets Mycophenolate 500mg POM Tablet Uncoated 195/063 Emcure Pharmaceuticals Limited, India

Page 104 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 2030 Atazor 100 Capsules Atazanavir 100mg POM Capsule oral 195/064 Emcure Pharmaceuticals Limited, India 2031 Atazor 150 Capsules Atazanavir 150mg POM Capsule oral 195/065 Emcure Pharmaceuticals Limited, India 2032 Atazor 200 Capsules Atazanavir 200mg POM Capsule oral 195/066 Emcure Pharmaceuticals Limited, India Lamivudine 150mg + POM Tablet Uncoated 195/067 Emcure Pharmaceuticals Limited, India Emtri Tablets Stavudine 30mg + 2033 Nevirapine 200mg Erythropoietin 4000 iu POM Solution for 195/068 Emcure Pharmaceuticals Limited, India Vintor 4000 Injection 2034 Injection Atazanavir Sulphate POM Capsule oral 195/069 Emcure Pharmaceuticals Limited, India Atazor 300 Capsules 2035 300mg Clopidogrel BiSulphate POM Tablet Uncoated 195/070 Emcure Pharmaceuticals Limited, India Antiplar Tablets 2036 75mg Atazanavir Sulphate POM Tablet Uncoated 195/071 Emcure Pharmaceuticals Limited, India Atazor - R Tablets 300mg + Ritonivir 100mg 2037 Cyanocobalamin 0.4 mcg P Tablet Film coated 195/072 Emcure Pharmaceuticals Limited, India + Elemental Zinc 4 mg + Folic Acid 45 mcg + Xplode Tablets Panax ginseng extract 42.5 mg + Resveratrol 75 mg + Vitamin C 20 mg 2038 Levocetirizine P Tablet Uncoated 195/073 Emcure Pharmaceuticals Limited, India Cerizine Tablets 2039 Hydrochloride BP 5mg 2040 Sustinex 30 Tablets Dapoxetine 30mg POM Tablet Uncoated 195/074 Emcure Pharmaceuticals Limited, India 2041 Proxym 300 Tablets Etodolac 300mg POM Tablet Film coated 195/075 Emcure Pharmaceuticals Limited, India Losartan Pottassium POM Tablet Uncoated 195/076 Emcure Pharmaceuticals Limited, India Asomex-LT Tablets 2042 +Amilodipine Besilate S (-) Pantoprazole POM Powder for 195/077 Emcure Pharmaceuticals Limited, India Panpure IV Injection 2043 Sodium Injection Pause Injection Tranexamic acid POM Solution for 195/078 Emcure Pharmaceuticals Limited, India 2044 500mg/5ml Injection Cefixime Trihydrate USP POM Tablet Uncoated 030/001 Emzor Exports Pvt Ltd, India Zoocef-200 Tablets 2045 200mg Cefixime Trihydrate USP POM Tablet Uncoated 030/002 Emzor Exports Pvt Ltd, India Zoocef-100 Tablets 2046 100mg Azithromycin Dihydrate POM Tablet Uncoated 030/003 Emzor Exports Pvt Ltd, India Azith-250 Tablets 2047 USP 250mg

Page 105 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Azithromycin Dihydrate POM Tablet Uncoated 030/004 Emzor Exports Pvt Ltd, India Azith-500 Tablets 2048 USP 500mg 2049 Rancip Tablets Ciprofloxacin 500mg POM Tablet Film coated 278/001 Erica Pharma Pvt Ltd, India Ericef Injection Ceftriaxone 1g POM Powder for 278/002 Erica Pharma Pvt Ltd, India 2050 Injection Ryvakelfin Tablets Pyrimthamine 25 + POM Tablet Uncoated 278/003 Erica Pharma Pvt Ltd, India 2051 Sulfadoxine 500 mg Erisunat Suspension Artesunate 160mg, per POM Suspension for 278/004 Erica Pharma Pvt Ltd, India 2052 80ml Oral Use Lumether Suspension Lumefantrine 120mg + POM Suspension for 278/005 Erica Pharma Pvt Ltd, India 2053 Artemether 20mg Oral Use Erinin Suspension Dihydroartemisinin POM Suspension 278/006 Erica Pharma Pvt Ltd, India 2054 160mg, per 80ml 2055 Ucon Capsules Fluconazole 200mg POM Capsule oral 278/007 Erica Pharma Pvt Ltd, India 2056 Optragen Eye Drops Gentamycin 0.3 % POM Eye Drops 278/008 Erica Pharma Pvt Ltd, India Eriamp Suspension Ampicillin 250mg, per POM Suspension for 278/009 Erica Pharma Pvt Ltd, India 2057 5ml Oral Use Erither Oral Suspension Artemether 180mg, per POM Solution for Oral 278/010 Erica Pharma Pvt Ltd, India 2058 5ml Use Erilife Powder Oral Rehydration Salts GS Powder for Oral 278/011 Erica Pharma Pvt Ltd, India 2059 10.5g Solution 2060 Erinin Tablets Dihydroartemisin 60mg POM Tablet Uncoated 278/012 Erica Pharma Pvt Ltd, India Eridol Oral Suspension Paracetamol 120mg, per GS Suspension for 278/013 Erica Pharma Pvt Ltd, India 2061 5ml Oral Use 2062 Erisunat Tablets Arthemether 100mg POM Tablet Uncoated 278/014 Erica Pharma Pvt Ltd, India Erither Injection Artemether 80mg, per ml POM Solution for 278/015 Erica Pharma Pvt Ltd, India 2063 Injection Lumether Tablets Lumefantrine 120mg + POM Tablet Film coated 278/016 Erica Pharma Pvt Ltd, India 2064 Artemether 20mg Rypanta Tablets Pantoprazole POM Tablet Enteric 278/017 Erica Pharma Pvt Ltd, India 2065 Sesquihydrate 40mg Coated 2066 Ryvazole Capsules Omeprazole 20mg POM Capsule oral 278/018 Erica Pharma Pvt Ltd, India Amoxer Oral Suspension Amoxicillin BP 250mg, POM Suspension for 278/019 Erica Pharma Pvt Ltd, India 2067 per 5ml Oral Use Tolybion Injection Vitamin B Complex POM Solution for 278/020 Erica Pharma Pvt Ltd, India 2068 Injection Ryvakelfin Oral Drops Pyrimthamine 25 + POM Solution for Oral 278/021 Erica Pharma Pvt Ltd, India Sulfadoxine 500mg, per Use 2069 10ml

Page 106 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 2070 Erither Capsules Artemether 40mg POM Capsule oral 278/022 Erica Pharma Pvt Ltd, India Erixime Injection Cefotaxime 1g POM Powder for 278/023 Erica Pharma Pvt Ltd, India 2071 Injection Oral Rehydration Salt Oral Rehydration Salt GS Powder for Oral 278/024 Erica Pharma Pvt Ltd, India 2072 Solution 2073 Furosemide Tablets Furosemide BP 40mg POM Tablet Uncoated 278/025 Erica Pharma Pvt Ltd, India Erimet 850 Tablets Metformin Hydrochloride POM Tablet Uncoated 278/026 Erica Pharma Pvt Ltd, India 2074 850mg Erion K Syrup Ferric Ammonium Citrate P Syrup 278/027 Erica Pharma Pvt Ltd, India USP + Folic Acid BP + Cynocobalamin 2075 Clauviax 625mg Tablets Amoxicillin USP + POM Tablet Uncoated 278/028 Erica Pharma Pvt Ltd, India 2076 Clavulanic Acid USP Chloramphenicol Sodium Chloramphenicol Sodium POM Powder for 278/032 Erica Pharma Pvt Ltd, India 2077 Succinate Injection Succinate 1g Injection Furosemide Injection Furosemide BP 10mg, POM Solution for 278/033 Erica Pharma Pvt Ltd, India 2078 per ml Injection Gentamycin Sulphate Injection Gentamycin Sulphate POM Solution for 278/034 Erica Pharma Pvt Ltd, India 2079 40mg, per ml Injection Rancip 250 Tablets Ciprofloxacin POM Tablet Uncoated 278/035 Erica Pharma Pvt Ltd, India 2080 Hydrochloride 250mg Cefax -250 Tablets Cefuroxime Axetil 250mg POM Tablet Uncoated 278/036 Erica Pharma Pvt Ltd, India 2081 Erimal Capsules Amodiquine POM Capsule oral 278/038 Erica Pharma Pvt Ltd, India Hydrochloride 300mg + 2082 Artesunate 100mg Erither 40 Injection Artemether 40mg, per ml POM Solution for 278/041 Erica Pharma Pvt Ltd, India 2083 Injection Vagiclin Suppositories Clindamycin+ POM Suppository 278/042 Erica Pharma Pvt Ltd, India 2084 Clotrimazole 2085 Optracip Drops Ciprofloxacin 0.3% POM Eye Drops 278/043 Erica Pharma Pvt Ltd, India 2086 Vagiclo Tablets Clotrimazole 100mg POM Tablet Vaginal 278/044 Erica Pharma Pvt Ltd, India Erimet Tablets Metformin Hydrochloride POM Tablet Uncoated 278/045 Erica Pharma Pvt Ltd, India 2087 500mg Clauviax -375 Amoxicillin 250mg + POM Tablet Uncoated 278/047 Erica Pharma Pvt Ltd, India 2088 Clavulanate 125mg Clauviax Suspension Amoxicillin 125mg + POM Suspension 278/048 Erica Pharma Pvt Ltd, India 2089 Clavulanate 31.25mg

Page 107 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 2090 Psyclocare Tablets Resperidone 2mg POM Tablet Uncoated 278/049 Erica Pharma Pvt Ltd, India Flucolife Infusion Fluconazole 200mg, per POM Solution for 307/001 Eurolife Healthcare PVT Ltd, India 2091 100ml infusion Mannilfe Infusion Mannitol 20g, per 100ml POM Solution for 307/002 Eurolife Healthcare PVT Ltd, India 2092 infusion Metlife Infusion Metronidazole 500mg, POM Solution for 307/003 Eurolife Healthcare PVT Ltd, India 2093 per 100ml infusion Sterile Water for Injection Water For Injection POM Solution for 307/004 Eurolife Healthcare PVT Ltd, India 2094 Injection Ciplife Infusion Ciprofloxacin 200mg, per POM Solution for 307/005 Eurolife Healthcare PVT Ltd, India 2095 100ml infusion Virecta Tablets Sildenafil Citrate I.H POM Tablet Uncoated 358/001 Eva Pharma 2096 100mg Vendexine Syrup Dexamethasone 0.5mg + P Syrup 358/002 Eva Pharma 2097 Chlorpheniramine 2mg 2098 Fusiderm Cream Fusidic acid 2% POM Cream Topical 358/003 Eva Pharma Electral Forte Powder Sodium GS Powder for Oral 197/001 FDC Limited, India Chloride,Potassium Solution Chloride, Sodium Citrate, 2099 Dextrose 24g Co-trimoxazole Tablets Sulphamethoxazole POM Tablet Uncoated 197/002 FDC Limited, India 400mg + Trimethoprim 2100 80mg Moisol Eye Drops Hydroxypropylmethyl P Eye Drops 197/003 FDC Limited, India 2101 Cellulose 0.7%w/v 2102 Pilocar Eye Drops Pilocarpine 2%w/v POM Eye Drops 197/004 FDC Limited, India Pyricort Eye/Ear Drops Dexamethasone + POM Ear/Eye Drops 197/005 FDC Limited, India 2103 Gentamycin 0.1%w/v Pyrimon Eye/Ear Drops Dexamethasone + POM Ear/Eye Drops 197/006 FDC Limited, India Chloramphenicol 2104 1.1%w/v 2105 Zoxan Eye/Ear Drops Ciprofloxacin 0.3%w/v POM Ear/Eye Drops 197/007 FDC Limited, India 2106 Ibuprofen Tablets Ibuprofen 200mg P Tablet Uncoated 197/008 FDC Limited, India 2107 Paracetamol Tablets Paracetamol BP 500mg GS Tablet Uncoated 197/010 FDC Limited, India Nucleo CMP Forte Capsules Cytidine -5 Disodium POM Capsule oral 366/001 Ferrer International S.A Monophosphate + 2108 Uridine Triphosphate

Page 108 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Nucleo Forte C.M.P Forte Cytidine -5-Disodium POM Solution for 366/002 Ferrer International S.A Injection Monophosphate (CMP - Injection 2109 Disodium Salt Urid Zalain Vaginal Suppository Sertaconazole Nitrate POM Suppository 366/003 Ferrer International S.A 2110 300mg Peitel 0.25% Cream Prednicarbate E.P. POM Cream Topical 366/006 Ferrer International S.A 2111 0.25% w/w Amoxycillin Oral Suspension Amoxycillin 250mg, per POM Suspension for 126/001 Flamingo Pharmaceuticals Limited, India 2112 5ml Oral Use Ampicillin 1000 Injection Ampicillin 1g POM Powder for 126/002 Flamingo Pharmaceuticals Limited, India 2113 Injection Ampicillin 500 Injection Ampicillin 500mg POM Powder for 126/003 Flamingo Pharmaceuticals Limited, India 2114 Injection 2115 Medampi Capsules Ampicillin 500mg POM Capsule oral 126/004 Flamingo Pharmaceuticals Limited, India Benzyl Penicillin Injection Benzyl Penicillin 1 Mega POM Powder for 126/005 Flamingo Pharmaceuticals Limited, India 2116 Injection 2117 Tetra 500 Capsules Tetracycline 500mg POM Capsule oral 126/006 Flamingo Pharmaceuticals Limited, India Kanamycin Injection Kanamycin 1g POM Powder for 126/007 Flamingo Pharmaceuticals Limited, India 2118 Injection Fortified Procaine Penicillin Procain Penicillin POM Powder for 126/008 Flamingo Pharmaceuticals Limited, India 2119 Injection Injection 2120 Ibuprofen 200mg Tablets Ibuprofen 200mg P Tablet Uncoated 126/009 Flamingo Pharmaceuticals Limited, India Compound Magnesuim Aluminium Hydroxide GS Tablet Uncoated 126/010 Flamingo Pharmaceuticals Limited, India Trisilicate Tablets 125mg + Magnesium 2121 Trisilicate 250mg Co-trimoxazole Suspension Sulphamethoxazole + POM Suspension for 126/011 Flamingo Pharmaceuticals Limited, India Trimethoprim 240mg, per Oral Use 2122 5ml 2123 Cephalexin 500 Capsules Cephalexin 500mg POM Capsule oral 126/012 Flamingo Pharmaceuticals Limited, India 2124 Amoxin 500 Capsules Amoxicillin 500mg POM Capsule oral 126/013 Flamingo Pharmaceuticals Limited, India 2125 Indo 25 Capsules Indomethacin 25mg P Capsule oral 126/014 Flamingo Pharmaceuticals Limited, India Erycin 125 Suspension Erythromycin 125mg, per POM Suspension for 126/015 Flamingo Pharmaceuticals Limited, India 2126 5ml Oral Use 2127 Quinine Tablets Quinine Sulphate 300mg POM Tablet Uncoated 126/016 Flamingo Pharmaceuticals Limited, India Metronidazole Suspension Metronidazole 125mg, POM Suspension for 126/017 Flamingo Pharmaceuticals Limited, India 2128 per 5ml Oral Use 2129 Medfulin Tablets Griseofulvin 500mg POM Tablet Uncoated 126/018 Flamingo Pharmaceuticals Limited, India 2130 Metroforce 200 Tablets Metronidazole 200mg POM Tablet Uncoated 126/019 Flamingo Pharmaceuticals Limited, India 2131 Reduced 300 Tablets Ranitidine 300mg POM Tablet Uncoated 126/020 Flamingo Pharmaceuticals Limited, India

Page 109 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 2132 Flamodip 10 Tablets Amlodipine 10mg POM Tablet Uncoated 126/021 Flamingo Pharmaceuticals Limited, India 2133 Flamodip 5 Tablets Amlodipine 5mg POM Tablet Uncoated 126/022 Flamingo Pharmaceuticals Limited, India 2134 Reduced 150 Tablets Ranitidine 150mg POM Tablet Uncoated 126/023 Flamingo Pharmaceuticals Limited, India 2135 Ibuprofen 400mg Tablets Ibuprofen 400mg P Tablet Uncoated 126/024 Flamingo Pharmaceuticals Limited, India 2136 Cardipril 2.5 Capsules Ramipril 2.5mg POM Capsule oral 126/025 Flamingo Pharmaceuticals Limited, India 2137 Mefenamic Acid Capsules Mefenamic Acid 500mg P Capsule oral 126/026 Flamingo Pharmaceuticals Limited, India Neumicin B Injection Benzathine Penicillin POM Powder for 126/027 Flamingo Pharmaceuticals Limited, India 2138 2.5Mega Injection 2139 Kamox 250 Capsules Amoxycillin 250mg POM Capsule oral 126/028 Flamingo Pharmaceuticals Limited, India 2140 Aziflam 250 Capsules Azithromycin 250mg POM Capsule oral 126/029 Flamingo Pharmaceuticals Limited, India Sodipen-5 Injection Benzyl Penicillin 5 Mega POM Powder for 126/030 Flamingo Pharmaceuticals Limited, India 2141 Injection 2142 Corin 50 Tablets Atenolol 50mg POM Tablet Uncoated 126/031 Flamingo Pharmaceuticals Limited, India 2143 Metformin Tablets Metformin 850mg POM Tablet Uncoated 126/032 Flamingo Pharmaceuticals Limited, India 2144 Glibetics Tablets Glibenclamide 5mg POM Tablet Uncoated 126/033 Flamingo Pharmaceuticals Limited, India Medichlor Injection Chloramphenicol 1g POM Powder for 126/034 Flamingo Pharmaceuticals Limited, India 2145 Injection 2146 Aziflam 500 Capsules Azithromycin 500mg POM Capsule oral 126/035 Flamingo Pharmaceuticals Limited, India Chloramphenicol Suspension Chloramphenicol 125mg, POM Suspension for 126/036 Flamingo Pharmaceuticals Limited, India 2147 per 5ml Oral Use 2148 Acenopril 5 Tablets Enalapril 5mg POM Tablet Uncoated 126/037 Flamingo Pharmaceuticals Limited, India 2149 Quinone G-500 Tablets Nalidixic acid 500mg POM Tablet Uncoated 126/038 Flamingo Pharmaceuticals Limited, India Magacid Oral Suspension Aluminium Hydroxide P Suspension for 126/039 Flamingo Pharmaceuticals Limited, India 200mg + Magnesium Oral Use Hydroxide 200mg + Simethicone 135mg, per 2150 5ml 2151 Acenopril 10 Tablets Enalapril 10mg POM Tablet Uncoated 126/040 Flamingo Pharmaceuticals Limited, India 2152 Corin 100 Tablets Atenolol 100mg POM Tablet Uncoated 126/041 Flamingo Pharmaceuticals Limited, India Coughex Syrup Salbutamol 1mg + GS Syrup 126/042 Flamingo Pharmaceuticals Limited, India Bromhexine 2mg + Guaiphenisin 50mg + 2153 Menthol 0.5mg 2154 Paracetamol BP Tablets Paracetamol 500mg GS Tablet Uncoated 126/043 Flamingo Pharmaceuticals Limited, India Trixone 1 Injection Cefotaxime 1g POM Powder for 126/044 Flamingo Pharmaceuticals Limited, India 2155 Injection Trixol 250 Injection Ceftriaxone 250mg POM Powder for 126/045 Flamingo Pharmaceuticals Limited, India 2156 Injection

Page 110 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Lexin 125 Oral Suspension Cephalexin 125mg, per POM Suspension 126/047 Flamingo Pharmaceuticals Limited, India 2157 5ml 2158 Lanocid 30 Capsules Lansoprazole 30mg POM Capsule oral 126/048 Flamingo Pharmaceuticals Limited, India 2159 Healz Tablets Serrapeptase 10mg POM Tablet Uncoated 126/049 Flamingo Pharmaceuticals Limited, India 2160 Profit Syrup Protein Syrup GS Syrup 126/051 Flamingo Pharmaceuticals Limited, India Hyomide 10 Tablets Hyoscine Butyl Bromide POM Tablet Uncoated 126/052 Flamingo Pharmaceuticals Limited, India 2161 10mg Cloxacillin Sodium Injection Cloxacillin 500mg, per ml POM Powder for 126/053 Flamingo Pharmaceuticals Limited, India 2162 Injection Cardilan Injection Hydrocortisone 100mg POM Powder for 126/054 Flamingo Pharmaceuticals Limited, India 2163 Injection 2164 Loperamide Capsules Loperamide 2mg POM Capsule oral 126/055 Flamingo Pharmaceuticals Limited, India Cefotax Powder for Injection Cefotaxime 1g POM Powder for 126/056 Flamingo Pharmaceuticals Limited, India 2165 Injection Ferrous Sulphate Tablets Ferrous Sulphate 200mg P Tablet Enteric 126/057 Flamingo Pharmaceuticals Limited, India 2166 Coated Cloxin DS Cloxacillin Sodium POM Powder for 126/058 Flamingo Pharmaceuticals Limited, India 2167 125mg Suspension 2168 Flamivit Syrup Multivitamins GS Syrup 126/059 Flamingo Pharmaceuticals Limited, India Kamox 125 Oral Suspension Amoxicillin 25mg, per 5ml POM Suspension for 126/060 Flamingo Pharmaceuticals Limited, India 2169 Oral Use 2170 Erycin Tablets Erythromycin 250mg POM Tablet Uncoated 126/063 Flamingo Pharmaceuticals Limited, India Angitan 50 Tablet Losartan Potassium POM Tablet oral 126/064 Flamingo Pharmaceuticals Limited, India 2171 50mg Co-trimoxazole Tablets Trimethoprim 80mg + POM Tablet Uncoated 139/046 Flamingo Pharmaceuticals Limited, India Sulphamethoxazole 2172 400mg 2173 Roxto-25 Tablets Rofecoxib 25mg POM Tablet Uncoated 139/050 Flamingo Pharmaceuticals Limited, India Aruj'a Hot Cream Menthol (Menta Piperita) P Cream Topical 408/008L Forest Gold Products (P) Ltd. 5.91% + Eucalyptus Oil 2174 (Eucalyptus Aruj'a Cool Gel Menthol (Menta Piperita P Gel Topical 408/009L Forest Gold Products (P) Ltd. 2175 2.0% w/w) Forever Kids Chewable Multivitamins P Tablet Uncoated 080/001 Forever Living Products, USA 2176 Multivitamins Tablets 2177 Forever Nature Min Tablets Minerals P Tablet Uncoated 080/002 Forever Living Products, USA 2178 Forever Absorbent-C Tablets Vitamin C 60mg P Tablet Uncoated 080/003L Forever Living Products, USA Forever Royal Jelly Tablets Royal Jelly powder P Powder for Oral 080/004L Forever Living Products, USA 2179 250mg Solution

Page 111 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 2180 Forever Bee Pollen Capsules Bee Pollen 500mg P Capsule oral 080/005L Forever Living Products, USA 2181 Forever Bee Propolis Tablets Bee Propolis 500mg P Tablet Uncoated 080/006L Forever Living Products, USA Forever Garlic- Thyme SoftGel Garlic Oil 10mg + Thyme P Tablet Uncoated 080/007L Forever Living Products, USA 2182 Capsules Powdered 50mg Forever Gin -Chia Tablets Premium Ginseng + P Tablet Uncoated 080/008L Forever Living Products, USA 80mg Oriental Ginseng 40mg + Siberian Ginseng 2183 20mg Ulgicid Suspension Alginic Acid BP 200 mg + P Suspension 246/006 Fountil Life Sciences, India Magnesium Hydroxide BP 250 mg + Dried Aluminium Hydroxide BP 250 mg + Magnesium Trisilicate BP 250 mg + Activated Dimethicone 2184 BP 125 mg/ 15ml Purecal Tablets Vitamin + Mineral P Tablets 246/007 Fountil Life Sciences, India 2185 Preparation Ulgicid Antacid Tablets Alginic Acid BP 200 mg + P Tablets 246/008 Fountil Life Sciences, India Magnesium Hydroxide BP 250 mg + Dried Aluminium Hydroxide BP 250 mg + Magnesium Trisilicate BP 250 mg + Activated Dimethicone 2186 BP 125 mg Capisfenac Gel Capsaicin 0.025%w/w + P Gel Topical 246/021 Fountil Life Sciences, India Diclofenc Diethylalamine 1.160%w/w + 2187 Levomenthol 1.00%w/w 2188 Diszinc Dispersible Tablets Zinc Sulfate 20mg POM Tablet Dispersible 246/022 Fountil Life Sciences, India Aminogard Granules Minerals + Vitamins P Granules for Oral 246/023 Fountil Life Sciences, India 2189 Use 2190 Primox 250 Capsules Amoxicillin 250mg POM Capsule oral 265/003 Fountil Life Sciences, India Pedifen Suspension Ibuprofen 100mg P Suspension for 151/033 Fourrts (India) Laboratories (Pvt) Limited 2191 Oral Use 2192 Omfil 20 Capsules Omeprazole 20mg POM Capsule oral 177/001 Fourrts (India) Laboratories (Pvt) Limited 2193 Ampifil 250 Capsules Ampicillin 250mg POM Capsule oral 177/002 Fourrts (India) Laboratories (Pvt) Limited 2194 Doxefil 100 Capsules Doxycycline 100mg POM Capsule oral 177/003 Fourrts (India) Laboratories (Pvt) Limited

Page 112 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 2195 Indoril 25 Capsules Indomethacin 25mg P Capsule oral 177/004 Fourrts (India) Laboratories (Pvt) Limited Gramofil Suspension Nalidixic Acid 300mg, per POM Suspension for 177/005 Fourrts (India) Laboratories (Pvt) Limited 2196 5ml Oral Use Malafil Tablets Pyrimethamine 25mg + P Tablet Uncoated 177/006 Fourrts (India) Laboratories (Pvt) Limited 2197 Sulphadoxine 500mg 2198 Griseofil Tablets Griseofulvin 500mg POM Tablet Uncoated 177/007 Fourrts (India) Laboratories (Pvt) Limited 2199 Micofil Cream Miconazole 2%w/w POM Cream Topical 177/008 Fourrts (India) Laboratories (Pvt) Limited Megatrim Suspension Sulphamethoxazole POM Suspension for 177/009 Fourrts (India) Laboratories (Pvt) Limited 200mg + Trimethoprim Oral Use 2200 40mg 2201 Prednifil Tablets Prednisolone 5mg POM Tablet Uncoated 177/010 Fourrts (India) Laboratories (Pvt) Limited Combifil 125 Tablets Pyrantel Pamoate 125mg P Tablet Uncoated 177/011 Fourrts (India) Laboratories (Pvt) Limited 2202 2203 Diclofil 50 Tablets Diclofenac 50mg P Tablet Uncoated 177/012 Fourrts (India) Laboratories (Pvt) Limited 2204 Parafil Tablets Paracetamol 500mg GS Tablet Uncoated 177/013 Fourrts (India) Laboratories (Pvt) Limited Clopen 500 Capsules Cloxacillin 250mg + POM Capsule oral 177/014 Fourrts (India) Laboratories (Pvt) Limited 2205 Ampicillin 250mg Gelfil Tablets Aluminium Hydrochloride GS Tablet Uncoated 177/015 Fourrts (India) Laboratories (Pvt) Limited 120mg + Magnesium 2206 Trisilicate 250mg 2207 Fungifen Cream Clotrimazole 1%w/w POM Cream Topical 177/016 Fourrts (India) Laboratories (Pvt) Limited Mebfil Suspension Mebendazole 100mg, P Suspension for 177/017 Fourrts (India) Laboratories (Pvt) Limited 2208 per 30ml Oral Use 2209 Felcine Capsules Piroxicam 20mg POM Capsule oral 177/018 Fourrts (India) Laboratories (Pvt) Limited Filobex Tablets Thiamine 1mg + P Tablet Uncoated 177/019 Fourrts (India) Laboratories (Pvt) Limited Riboflavine 1mg + 2210 Niacinamide 10mg Gliclan M Tablets Metformin 250mg + POM Tablet Uncoated 177/020 Fourrts (India) Laboratories (Pvt) Limited 2211 Gliclazide 80mg 2212 Gramofil Tablets Nalidixic acid 500mg POM Tablet Uncoated 177/021 Fourrts (India) Laboratories (Pvt) Limited 2213 Ibufil Tablets Ibuprofen 200mg P Tablet Uncoated 177/022 Fourrts (India) Laboratories (Pvt) Limited 2214 Mebfil Tablets Mebendazole 100mg P Tablet Uncoated 177/023 Fourrts (India) Laboratories (Pvt) Limited Megatrim Tablets Sulfamethoxazole 400mg POM Tablet Uncoated 177/024 Fourrts (India) Laboratories (Pvt) Limited + Trimethoprim 80mg 2215 2216 Metfil 850 Tablets Metformin 850mg POM Tablet Uncoated 177/025 Fourrts (India) Laboratories (Pvt) Limited 2217 Salfil 4 Tablets Salbutamol 4mg POM Tablet Uncoated 177/026 Fourrts (India) Laboratories (Pvt) Limited 2218 Salfil 2 Tablets Salbutamol 2mg POM Tablet Uncoated 177/027 Fourrts (India) Laboratories (Pvt) Limited 2219 Cipfil 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 177/028 Fourrts (India) Laboratories (Pvt) Limited

Page 113 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Fourts B Tablets Multivitamins + Amino P Tablet Uncoated 177/029 Fourrts (India) Laboratories (Pvt) Limited 2220 Acids + Minerals 2221 Metfil 500 Tablets Metformin 500mg POM Tablet Uncoated 177/030 Fourrts (India) Laboratories (Pvt) Limited Salbutamol Oral Solution Salbutamol 2mg POM Solution for Oral 177/031 Fourrts (India) Laboratories (Pvt) Limited 2222 Use Fogyl Suspension Metronidazole 100mg POM Suspension for 177/032 Fourrts (India) Laboratories (Pvt) Limited 2223 Oral Use 2224 Profil 25 Tablets Promethazine 25mg P Tablet Uncoated 177/033 Fourrts (India) Laboratories (Pvt) Limited 2225 Cloxafil 250 Capsules Cloxacillin 250mg POM Capsule oral 177/035 Fourrts (India) Laboratories (Pvt) Limited Parafil 120 Oral Solution Paracetamol 120mg GS Solution for oral 177/036 Fourrts (India) Laboratories (Pvt) Limited 2226 use 2227 Betafil-50 Tablets Atenolol 50mg POM Tablet Uncoated 177/037 Fourrts (India) Laboratories (Pvt) Limited 2228 Gliclan 80 Tablets Gliclazide 80mg POM Tablet Uncoated 177/038 Fourrts (India) Laboratories (Pvt) Limited 2229 Fomycetin 250 Capsules Chlorampenicol 250mg POM Capsule oral 177/039 Fourrts (India) Laboratories (Pvt) Limited 2230 Fogyl-S Tablets Metronidazole 200mg POM Tablet Uncoated 177/040 Fourrts (India) Laboratories (Pvt) Limited 2231 Multivitamin Tablets Multivitamin Tablets P tablets 177/041 Fourrts (India) Laboratories (Pvt) Limited Glifil-M Forte Tablets Glibenclamide 5mg + POM Tablet Uncoated 177/042 Fourrts (India) Laboratories (Pvt) Limited 2232 Metformin 500mg Quadrajel Chlorhexidine 1% + P Gel Oral 177/043 Fourrts (India) Laboratories (Pvt) Limited Gluconate Solution 1% + Metronidazole Benzoate 2233 2% Combifil Suspension Pyrantel Pamoate P Suspension for 177/044 Fourrts (India) Laboratories (Pvt) Limited 2234 250mg, per 5ml Oral Use 2235 Kontrac- 200 Tablets Misoprostol 200mcg POM Tablet Uncoated 177/045 Fourrts (India) Laboratories (Pvt) Limited 2236 Tinifil Tablets Tinidazole 500mg POM Tablet Uncoated 177/046 Fourrts (India) Laboratories (Pvt) Limited Redin plus Capsules Iron+ Folic Acid 1000mg POM Capsule oral 177/048 Fourrts (India) Laboratories (Pvt) Limited + Zinc Sulphate 5mg + Selenium 30mg + 2237 Histidine 50mg Cold Fortinsa Tablets Paracetamol 500mg + P Tablets Uncoated 177/049 Fourrts (India) Laboratories (Pvt) Limited Phenylephrine 5mg + Chlorpheniramine 2mg + 2238 Caffeine 30mg Ambcet Syrup Ambroxol Hydrochloride P Syrup 177/050 Fourrts (India) Laboratories (Pvt) Limited 30mg + Cetirizine 2239 Hydrochloride 5mg

Page 114 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Ambcet Tablets Ambroxol Hydrochloride P Tablet Uncoated 177/051 Fourrts (India) Laboratories (Pvt) Limited 60mg + Cetirizine 2240 Hydrochloride 5mg Ibufil Suspension Ibuprofen 100mg, per 5ml P Suspension for 177/052 Fourrts (India) Laboratories (Pvt) Limited 2241 Oral Use L-Montus Tablets Levocetirizine P Tablet Uncoated 177/053 Fourrts (India) Laboratories (Pvt) Limited Hydrochloride 5mg + Montelukast Sodium 2242 10mg 2243 Cipfil 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 3129/05 Fourrts (India) Laboratories (Pvt) Limited Redin PN liquid Haematenic + Calcium + POM Solution for Oral 177/047 Fourrts (India) Laboratories (Pvt) Limited, 2244 Protein + Minerals Use india Surfaz® Dusting Powder Clotrimazole 1%w/w P Powder for Topical 062/007 Franco-Indian Remedies Pvt Ltd, India 2245 use Diavit Plus Capsules Alpha Lipoic Acid P Capsule oral 222/005 Franco-Indian Remedies Pvt Ltd, India USP.NF 200 mg + Beta Carotene USP (200mg+3mg+1500mcg+ 20mg+70mcg+50mcg+40 2246 mg+2mg+0.5mg+) Stimuliv Syrup Kalmegh (Andrographis P Syrup 222/006 Franco-Indian Remedies Pvt Ltd, India paniculata) 60mg + Bhringaraj (Eclipta 2247 100mg+100mg Omilcal Forte Tablets Tribasic Calcium P Tablet Uncoated 222/007 Franco-Indian Remedies Pvt Ltd, India Phosphate BP 1032mg + Heavy Magnesium Oxide 66.32mg+26.40mg+6mg 2248 2249 Glyciphage Tablets Metformin 500mg POM Tablet Uncoated 274/001 Franco-Indian Remedies Pvt Ltd, India 2250 Beneuron Forte Tablets Multivitamin GS Tablet Film coated 274/002 Franco-Indian Remedies Pvt Ltd, India 2251 Beetrion Tablets Multivitamin & Minerals GS Tablet Film coated 274/003 Franco-Indian Remedies Pvt Ltd, India Propofol 1% Infusion Propofol 10mg, per ml POM Solution for 253/001 Frenesius Kabi S.A (Pty) Ltd, South Africa 2252 infusion 2253 Voluven Emulsion Hydroxyethyl 60g, per L POM Emulsion 253/002 Frenesius Kabi S.A (Pty) Ltd, South Africa CAPD/DPCA 2 Stay safe Peritoneal Dialysis POM Solution for 254/030 Frenesius Kabi S.A (Pty) Ltd, South Africa 2254 Solution Solution infusion CAPD/DPCA 3 Stay safe Peritoneal Dialysis POM Solution for 254/031 Frenesius Kabi S.A (Pty) Ltd, South Africa 2255 Solution Solution infusion

Page 115 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER CAPD/DPCA 4 Stay safe Peritoneal Dialysis POM Solution for 254/032 Frenesius Kabi S.A (Pty) Ltd, South Africa 2256 Solution Solution infusion Gemita Injection Gemcitabine 1g POM Solution for 254/033 Frenesius Kabi S.A (Pty) Ltd, South Africa 2257 Injection Gemita 200 mg Injection Gemcitabine 200mg POM Solution for 254/034 Frenesius Kabi S.A (Pty) Ltd, South Africa 2258 Injection Intaxel Injection Paclitaxel 30mg, per 5ml POM Solution for 254/035 Frenesius Kabi S.A (Pty) Ltd, South Africa 2259 Injection Irinotel Injection Irinotecan 100mg POM Solution for 254/036 Frenesius Kabi S.A (Pty) Ltd, South Africa 2260 Injection Kemocarb Injection Carboplatin 150mg POM Solution for 254/037 Frenesius Kabi S.A (Pty) Ltd, South Africa 2261 Injection Oxitan Injection Oxaliplatin 50mg POM Solution for 254/038 Frenesius Kabi S.A (Pty) Ltd, South Africa 2262 Injection 2263 Trozet Tablets Letrozole 2.5mg POM Tablet Uncoated 254/039 Frenesius Kabi S.A (Pty) Ltd, South Africa Kabiven Emulsion for Injection Glucose + Amino acids+ POM Emulsion 254/041 Frenesius Kabi S.A (Pty) Ltd, South Africa 2264 Minerals + Lipids Vitalipid Novum Adult Retinol palmitate 194.1 POM Emulsion for 254/043 Fresenius Kabi S.A (Pty) Ltd, South Africa mcg + dl-a-tocopherol infusion 0.91mcg + Ergocalc 2265 0.5mcg paracetamol Fresenius Infusion Paracetamol 1000mg POM Solution for 254/044 Fresenius Kabi S.A (Pty) Ltd, South Africa 2266 infusion Smofkabiven® 800 SMOFlipid 20% / POM Emulsion for 254/045 Fresenius Kabi S.A (Pty) Ltd, South Africa Aminoven 10% (with or infusion without electrolytes) / 2267 glucose 42% - 800 kcal Smofkabiven® 1100 SMOFlipid 20% / POM Emulsion for 254/046 Fresenius Kabi S.A (Pty) Ltd, South Africa Aminoven 10% (with or infusion without electrolytes) / 2268 glucose 42% - 1100 kcal Paracetamol Fresenius Infusion Paracetamol 1000mg POM Solution for 254/044 Fresenius Kabi South Africa 2269 Infusion Vincristine Sulphate Liquid Vincristine 1mg, per ml POM Solution for 299/001MT Furen Pharmaceuticals Group Co. Limited 2270 Injection Injection Water for Injection BP Water For Injection BP POM Solution for 299/002MT Furen Pharmaceuticals Group Co. Limited 2271 Injection

Page 116 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER MZ – CAL Tablets Calcium P Tablet Uncoated 372/001 Galaxy Pharmaceuticals Ltd Carbonate1000mg+Miner 2272 als MZ – CAL Suspension Calcium carbonate BP Pharmacy Suspension for 372/002 Galaxy Pharmaceuticals Ltd equi. To Calcium Medicine Oral Use 2273 150mg+Minerals Foetasafe Capsuless Omega 3 Fish Oil 600mg Pharmacy Capsule oral 372/003 Galaxy Pharmaceuticals Ltd 2274 +Vitamins + Minerals Medicine Ginesomega Soft Capsuless Ginseng extract BP 50mg Pharmacy Capsule oral 372/004 Galaxy Pharmaceuticals Ltd + Cod liver Oil BP 50mg Medicine 2275 + Omega -3 F Cardiocare SoftGel Capsuless Alpha Lipoic Acid USP Pharmacy Capsule oral 372/005 Galaxy Pharmaceuticals Ltd 50mg + Coenzyme Q10 Medicine 2276 USP 50mg + Citrus Neurocare Plus SoftGel Methycobalanin 750mcg+ Pharmacy Capsule oral 372/006 Galaxy Pharmaceuticals Ltd Capsules Alpha Lipoic Acid USP Medicine 100mg+ B6 BP 3mg +FA 1.5mg +Pregabalin 2277 7.5mg Vita UVD3 60000 SoftGel Vitamin D3 BP 60000 IU Pharmacy Capsule oral 372/007 Galaxy Pharmaceuticals Ltd 2278 Capsuless Medicine Cartilomega SoftGel Capsuless Glucosamine Sulphate Pharmacy Capsule Softgel 372/009L Galaxy Pharmaceuticals Ltd USP 500mg + Medicine Chondroitin Sulphate USP 200mg + Sodium H 2279 3mg 2280 Fungigen Cream Miconazole 1%w/w POM Cream Topical 218/001 Galentic Pharma Limited, India 2281 Derm Keta Cream Ketoconazole 2.0%w/w POM Cream Topical 218/002 Galentic Pharma Limited, India 2282 Netracort Ointment Hydrocortisone 10mg POM Ointment topical 218/003 Galentic Pharma Limited, India Sylvadex Cream Silver Sulfadiazine P Cream Topical 218/004 Galentic Pharma Limited, India 2283 1.0%w/w 2284 Kloraxin Eye Ointment Chloramphenicol 1%w/w POM Eye Ointment 218/005 Galentic Pharma Limited, India 2285 Diclofenac Gel Diclofenac 1.0%w/w P Gel Topical 218/006 Galentic Pharma Limited, India Tetracycline Hydrochloride Tetracycline 1%w/w POM Ointment topical 218/007 Galentic Pharma Limited, India 2286 Ointment Tetracycline Hydrochloride Tetracycline 3%w/w POM Ointment topical 218/008 Galentic Pharma Limited, India 2287 Ointiment 2288 Netracort Skin Ointment Hydrocortisone 1%w/w POM Ointment topical 218/009 Galentic Pharma Limited, India

Page 117 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Pyloocain Ointment Bethametasone 0.5mg + POM Ointment topical 218/010 Galentic Pharma Limited, India Phenylephrine 1mg + 2289 Lidocaine 25mg Caladine lotion Calamine 5% P Lotion for Topical 218/011 Galentic Pharma Limited, India 2290 Use Neurocare SoftGel Capsules Methylcobalanin P Capsule oral 372/008L Galentic Pharma Limited, India 1500mcg + Gamma Linolenic Acid 60mg + Alpha Lipoic Acid USP 100mg +1.5mg + 3mg + 2291 100mcg + 10mg Helmanil Oral Suspension Albendazole 200mg, per POM Suspension for 200/001 Galpha Laboratories Ltd,India 2292 5ml Oral Use Odicef Injection Ceftriaxone 1gm POM Powder for 200/002 Galpha Laboratories Ltd,India 2293 Injection Aben Oral Suspension Mebendazole 100mg, per P Suspension for 200/003 Galpha Laboratories Ltd,India 2294 5ml Oral Use 2295 Galmox Capsuless Amoxicillin 250mg POM Capsule oral 200/004 Galpha Laboratories Ltd,India Clanoxy 375 Tablets Amoxicillin 250mg + POM Tablet Film coated 200/005 Galpha Laboratories Ltd,India Clavulanate Potassium 2296 125mg 2297 Galexin 250 Capsuless Cephalexin 250mg POM Capsule oral 200/006 Galpha Laboratories Ltd,India Galmox 125 Oral Suspension Amoxicillin 125mg, per POM Powder for Oral 200/008 Galpha Laboratories Ltd,India 2298 5ml Suspension Malartem Injection Artemether 80mg, per ml POM Solution for 200/009 Galpha Laboratories Ltd,India 2299 Injection Gallin Oral Suspension Ampicillin 125mg, per POM Powder for Oral 200/010 Galpha Laboratories Ltd,India 2300 5ml Suspension Potamp 500 Capsuless Cloxacillin 250mg + POM Capsule oral 200/011 Galpha Laboratories Ltd,India 2301 Ampicillin 250mg 2302 Galin Capsuless Ampicillin 250mg POM Capsule oral 200/012 Galpha Laboratories Ltd,India Metrogal Oral Suspension Metronidazole 200mg, POM Suspension for 200/014 Galpha Laboratories Ltd,India 2303 per 5ml Oral Use Clanoxy Dry Syrup Amoxicillin 200mg + POM Powder for Oral 200/015 Galpha Laboratories Ltd,India Clavulanic acid 28.5mg , Suspension 2304 per 5ml 2305 Galdic SR 100 Tablets Diclofenac 100mg P Tablet Film coated 200/016 Galpha Laboratories Ltd,India Hydrocortisone Sodium Injection Hydrocortisone 100mg, POM Powder for 200/017 Galpha Laboratories Ltd,India 2306 per 7.5ml Injection

Page 118 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 2307 Restum 500 Tablets Cefuroxime 500mg POM Tablet Uncoated 200/018 Galpha Laboratories Ltd,India 2308 Restum 250 Tablets Cefuroxime 250mg POM Tablet Uncoated 200/019 Galpha Laboratories Ltd,India Altax Powder for Injection Cefotaxime 1gm POM Powder for 200/020 Galpha Laboratories Ltd,India 2309 Injection Galprim-P Suspension Trimethoprim 40mg + POM Suspension 200/022 Galpha Laboratories Ltd,India Sulphamethoxazole 2310 200mg, per 5ml Ecocin Suspension Paracetamol 125mg, per GS Suspension for 200/023 Galpha Laboratories Ltd,India 2311 5ml Oral Use Clanoxy 625 Tablets Amoxycillin 500mg + POM Tablet Uncoated 200/024 Galpha Laboratories Ltd,India Clavulanate Potassium 2312 125mg Galclox Oral Suspension Cloxacillin 125mg, per POM Suspension for 200/025 Galpha Laboratories Ltd,India 2313 5ml Oral Use Galthrox 125 Oral Suspension Erythromycin 125mg, per POM Suspension for 200/026 Galpha Laboratories Ltd,India 2314 5ml Oral Use 2315 Dr-x 50 Tablets Sildenafil 50mg POM Tablet Uncoated 200/027 Galpha Laboratories Ltd,India Galexin 125 Suspension Cefalexin 125mg, per 5ml POM Suspension for 200/028 Galpha Laboratories Ltd,India 2316 Oral Use 2317 Azvit-M Syrup Multivitamins GS Syrup 200/029 Galpha Laboratories Ltd,India Galgin Capsules Dimethicone + P Suspension 200/030 Galpha Laboratories Ltd,India Magnesium + Aluminium 2318 Hydroxide 2319 Galamine P Syrup Chlorpheniramine 2mg P Syrup 200/031 Galpha Laboratories Ltd,India Desol Ear Drops Paradichlorobenzene P Ear Drops 273/001 Geno Pharmaceuticals Ltd, India 21.5mg + Benzocaine 25mg + Chlorobutanol 55mg + Turpentine 2320 157mg Cypon Syrup Cyproheptadine + P Syrup 273/002 Geno Pharmaceuticals Ltd, India 2321 Tricholine Brupal Tablets Ibuprofen 400mg + P Tablet Uncoated 273/003 Geno Pharmaceuticals Ltd, India 2322 Paracetamol 325mg Peptica Gel Aluminium Hydroxide P Suspension for 273/004 Geno Pharmaceuticals Ltd, India 225mg + Magnesium Oral Use Hydroxide 200mg + 2323 Simethicone U 50mg

Page 119 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Respira Cough Formula Ambroxol Hydrochloride P Syrup 273/005 Geno Pharmaceuticals Ltd, India 1.65mg + Salbutamol Sulphate 1.3mg + 2324 Guafene 50mg Myloxin - D Gel Oleoresin Capiscum GS Gel Topical 273/006 Geno Pharmaceuticals Ltd, India 0.075%w/w + Methyl Salicylate 20%w/w + Menthol 10%w/w + 2325 Camph 5%w/w Respira - D Cough Formula Dextromethophan P Syrup 273/007 Geno Pharmaceuticals Ltd, India Hydrobromide BP 10mg + Chlorpheinramine 2326 Maleate BP 2mg Deriphyllin 300 Retard Tablets Theophylline Anhydrous POM Tablet Film coated 159/001 Germany Remedies, India BP + Etofylline BP 2327 300mg Deriphyllin 150 Retard Tablets Theophylline Anhydrous POM Tablet Film coated 159/002 Germany Remedies, India BP + Etofylline BP 2328 150mg Deriphylline Tablets Theophylline Anhydous POM Tablet Uncoated 159/003 Germany Remedies, India 2329 BP + Etofylline BP Deriphylline Injection Theophylline Anhydrous POM Solution for 159/004 Germany Remedies, India 2330 BP + Etofylline BP Injection Deriphylline Syrup Theophylline Anhydrous POM Syrup 159/005 Germany Remedies, India 2331 BP + Etofylline BP Kalzana Tablets Ascobic acid 40mg + P Tablet Uncoated 159/006 Germany Remedies, India Cholecalciferol BP 200iu+ Dibasic Calcium 2332 Phosphate BP 100mg Carbotin Injection Carboplatin 150mg, per POM Powder for 302/001 Getwell Pharmaceuticals Limited 2333 15ml Injection Doxoruba Injection Doxorubicin 50mg, per POM Powder for 302/002 Getwell Pharmaceuticals Limited 2334 25ml Injection Pacliwel Injection Paclitaxel 30mg, per 5ml POM Powder for 302/003 Getwell Pharmaceuticals Limited 2335 Injection Platicin Injection Cisplatin 10mg, per 10ml POM Powder for 302/004 Getwell Pharmaceuticals Limited 2336 Injection Taxewell Injection Docetaxel 120mg, per POM Powder for 302/005 Getwell Pharmaceuticals Limited 2337 3ml Injection

Page 120 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Zoldron Injection Zoledronic Acid 4mg, per POM Powder for 302/006 Getwell Pharmaceuticals Limited 2338 4ml Injection Viread 150 Tablets Tenofovir Fumarate POM Tablet Film coated 440/001 Gilead Sciences Inc. USA 2339 150mg Viread 200mg Tablets Tenofovir Disoproxil POM Tablet Film coated 440/002 Gilead Sciences Inc. USA 2340 Fumarate 200mg Viread 250mg Tablets Tenofovir Disoproxil POM Tablet Film coated 440/003 Gilead Sciences Inc. USA 2341 Fumarate 250mg Frusemide Injection Frusemide 10mg, per ml POM Solution for 403/001 Gland Pharma Ltd. India 2342 Injection Hyoscine Butylbromide Injection Hyoscine Butylbromide POM Solution for 403/002 Gland Pharma Ltd. India 2343 20mg Injection Actifed Cold Tablets Tripolidine Hydrochloride P Tablets 025/004 GlaxoSmithKline Consumer Healthcare 1.25mg + Pseudoephrine (Pty) Ltd, South Africa Hydrochloride 3.00mg 2344 Eno Active Fruit Salts Citric Acid 2.16g + GS Powder for Oral 025/016 GlaxoSmithKline Consumer Healthcare Sodium Bicarbonate Solution (Pty) Ltd, South Africa 2.29g + Sodium 2345 Carbonate 0.5g Grandpa Tablets Aspirin 226.8mg + GS Tablet Uncoated 025/017 GlaxoSmithKline Consumer Healthcare Caffeine 32.4mg + (Pty) Ltd, South Africa 2346 Paracetamol 162.0mg Calpol Paediatric Suspension Paracetamol 120 mg, per GS Suspension for 025/018 GlaxoSmithKline Consumer Healthcare 2347 5ml Oral Use (Pty) Ltd, South Africa Grandpa Headache Powder Aspirin 453.6mg + GS Powder for Oral 025/019 GlaxoSmithKline Consumer Healthcare Caffeine 64.5mg + Suspension (Pty) Ltd, South Africa 2348 Paracetamol 324mg Med Lemon Sachets Aspirin 800mg + Caffeine GS Powder for Oral 179/067 GlaxoSmithKline Consumer Healthcare 50mg + Ascorbic Acid Solution (Pty) Ltd, South Africa 2349 48mg Actifed Compound Linctus Triprolidine + P Syrup 025/001 GlaxoSmithKline Consumer Healthcare SA Pseudoephedrine + Limited 2350 Dextromethorphen Actifed Syrup Triprolidine + P Syrup 025/003 GlaxoSmithKline Consumer Healthcare SA 2351 Pseudoephedrine Limited Eltroxin Tablets Thyroxine 100mcg POM Tablet Uncoated 179/052 GlaxoSmithKline Consumer Healthcare SA 2352 Limited

Page 121 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Corsodyl Mouthwash - Mint Chlorhexidine Gluconate GS Solution for Oral 179/061 GlaxoSmithKline Consumer Healthcare SA 2353 2mg, per ml Use Limited Med-Lemon HM with Vitamin C Aspirin 800 mg + GS powder for 179/067 GlaxoSmithKline Consumer Healthcare SA Powder for Suspension Caffeine 50 mg + Suspension Limited Ascorbic Acid 45 mg + 2354 Menthol 2.6mg Vibrocil Nasal Drops Phenylephrine + P Nasal drops 242/003 GlaxoSmithKline Consumer Healthcare SA 2355 Dimethendene Limited Proctoglyvenol Cream Lidocaine + Tribenocide POM Cream Topical 242/004 GlaxoSmithKline Consumer Healthcare SA 2356 Limited Otrivin Spray Xylometazoline 0.1%w/v POM Spray For Nasal 242/006 GlaxoSmithKline Consumer Healthcare SA 2357 Use Limited Lamisil Cream Terbinafine 10% POM Cream Topical 242/008 GlaxoSmithKline Consumer Healthcare SA 2358 Limited Eurax Cream Crotamiton 10% POM Cream Topical 242/012 GlaxoSmithKline Consumer Healthcare SA 2359 Limited Otrivin Nasal Drops Xylometazoline P Nasal drops 242/013 GlaxoSmithKline Consumer Healthcare SA Hydrochloride 0.05% w/v Limited 2360 Otrivin Nasal Drops-Adults Xylometazoline P Nasal drops 242/014 GlaxoSmithKline Consumer Healthcare SA 2361 Hydrochloride 0.1% w/v Limited Voltaren Gel Diclofenac Diethylamide POM Topical gel 242/015 GlaxoSmithKline Consumer Healthcare SA corresponding to 1g Limited Diclofenac Sodium per 2362 100g Calcium Forte Effervescent Calcium Carbonate 0.3g P Effervescent 242/016 GlaxoSmithKline Consumer Healthcare SA Tablets + Calcium lactate Tablets Limited Gluconate 2.94g equivalent to 500mg 2363 elemental Calcium Calcium + Vitamin C Tablets Ascorbic Acid 1000mg + P Tablets Uncoated 242/017 GlaxoSmithKline Consumer Healthcare SA Calcium Lactate Limited Gluconate 1000mg + Calcium Carbonate 2364 327mg Panado Advance Tablets Paracetamol 500mg GS Tablets Uncoated 242/019 GlaxoSmithKline Consumer Healthcare SA 2365 Limited Panado Extra Tablets Paracetamol 500mg + GS Tablets Uncoated 242/020 GlaxoSmithKline Consumer Healthcare SA 2366 Caffeine Limited

Page 122 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Rotarix Vaccine Live attenauted Human POM Oral Suspension 025/034 GlaxoSmithKline SA (Pty) Ltd Rotovirus RIX 4414 2367 1000000 CCID 50 Clavulin Suspension Amoxicillin + Clavulanic POM Suspension for 179/001 GlaxoSmithKline SA (Pty) Ltd 2368 Acid 156mg, per 5ml Oral Use 2369 Bactroban Cream Mupirocin 10.5% POM Cream Topical 179/003 GlaxoSmithKline SA (Pty) Ltd 2370 Ziagen Tablets Abacavir 300mg POM Tablet Uncoated 179/004 GlaxoSmithKline SA (Pty) Ltd Combivir Tablets Lamivudine 150mg + POM Tablet Uncoated 179/005 GlaxoSmithKline SA (Pty) Ltd 2371 Zidovudine 300mg Epivir Oral Solution Lamivudine 10mg, per ml POM Solution for Oral 179/006 GlaxoSmithKline SA (Pty) Ltd 2372 use 2373 Epivir Tablets Lamivudine 150mg POM Tablet film coated 179/007 GlaxoSmithKline SA (Pty) Ltd 2374 Alben 400 Tablets Albendazole 400mg POM Tablet Uncoated 179/008 GlaxoSmithKline SA (Pty) Ltd Augmentin Oral Suspension Amoxicillin + Clavulanic POM Suspension for 179/009 GlaxoSmithKline SA (Pty) Ltd 2375 Acid Oral Use Telzir Suspension Fosamprenavir 50mg, POM Suspension for 179/010 GlaxoSmithKline SA (Pty) Ltd 2376 per ml Oral Use Kivexa Tablets Abacavir 600mg + POM Tablet film coated 179/011 GlaxoSmithKline SA (Pty) Ltd 2377 Lamivudine 300mg Zinnat Suspension Cefuroxime 125mg, per POM Suspension for 179/013 GlaxoSmithKline SA (Pty) Ltd 2378 5ml Oral Use Flixonase Aqueous Nasal Spray Fluticasone Propionate POM Nasal spray 179/014 GlaxoSmithKline SA (Pty) Ltd (Micronized fluticasone 2379 propionate 0.5% w/w) 2380 Zinnat 500 Tablets Cefuroxime 500mg POM Tablet Uncoated 179/015 GlaxoSmithKline SA (Pty) Ltd Zinacef Injection Cefuroxime 750mg POM Solution for 179/016 GlaxoSmithKline SA (Pty) Ltd 2381 Injection 2382 Zinnat 250 Tablets Cefuroxime 250mg POM Tablet Uncoated 179/017 GlaxoSmithKline SA (Pty) Ltd Engerix B Paediatric Tablets Hepatitis B 10mcg, per POM Tablet Uncoated 179/018 GlaxoSmithKline SA (Pty) Ltd 2383 0.5ml Engerix B Adult Injection Hepatitis B 20mcg, per POM Tablet Uncoated 179/019 GlaxoSmithKline SA (Pty) Ltd 2384 ml Halfan Suspension Halofantrine 125mg, per POM Suspension for 179/020 GlaxoSmithKline SA (Pty) Ltd 2385 5ml Oral Use 2386 Halfan Tablets Halofantrine 250mg POM Tablet Uncoated 179/021 GlaxoSmithKline SA (Pty) Ltd 2387 Zentel 400 Tablets Albendazole 400mg POM Tablet Uncoated 179/022 GlaxoSmithKline SA (Pty) Ltd Otosporin Ear Drops Hydrocortisone + POM Ear Drops 179/028 GlaxoSmithKline SA (Pty) Ltd 2388 Neomycin + Polymixin B

Page 123 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Augmentin SF Suspension Amoxicillin 200mg + POM Tablet Uncoated 179/030 GlaxoSmithKline SA (Pty) Ltd Potassium Clavulanate 2389 28.50mg Augmentin BD Suspension Amoxicillin + Potassium POM Suspension for 179/032 GlaxoSmithKline SA (Pty) Ltd 2390 Clavulanate 375mg Oral Use Zentel Suspension Albendazole 125mg POM Suspension for 179/033 GlaxoSmithKline SA (Pty) Ltd 2391 Oral Use 2392 Flixotide Inhaler Fluticasone 1g POM Capsule oral 179/034 GlaxoSmithKline SA (Pty) Ltd 2393 Flixotide 125 Inhaler Fluticasone 125mcg POM Capsule oral 179/035 GlaxoSmithKline SA (Pty) Ltd Flixotide Inhaler Fluticasone 50mcg POM Solution for 179/036 GlaxoSmithKline SA (Pty) Ltd 2394 Injection Augmentin BD Tablets Amoxicillin + Potassium POM Suspension for 179/037 GlaxoSmithKline SA (Pty) Ltd 2395 Clavulanate 1g Oral Use Ventolin cfc Inhaler Salbutamol 100mcg POM Solution for 179/038 GlaxoSmithKline SA (Pty) Ltd 2396 Inhalation Seretide Inhaler Salmeterol 25mg + POM Solution for 179/039 GlaxoSmithKline SA (Pty) Ltd 2397 Fluticasone 100mg Inhalation Seretide Inhaler Salmeterol 25mg + POM Solution for 179/040 GlaxoSmithKline SA (Pty) Ltd 2398 Fluticasone 125mg Inhalation Seretide Inhaler Salmeterol 25mg + POM Solution for 179/041 GlaxoSmithKline SA (Pty) Ltd 2399 Fluticasone 250mg Inhalation Seretide Inhaler Salmeterol 50mg + POM Solution for 179/042 GlaxoSmithKline SA (Pty) Ltd 2400 Fluticasone 100mg Inhalation Seretide Inhaler Salmeterol 50mg + POM Solution for 179/043 GlaxoSmithKline SA (Pty) Ltd 2401 Fluticasone 250mg Inhalation Seretide Inhaler Salmeterol 50mg + POM Solution for 179/044 GlaxoSmithKline SA (Pty) Ltd 2402 Fluticasone 500mg Inhalation Augmentin Suspension Amoxicillin 125mg + POM Suspension for 179/045 GlaxoSmithKline SA (Pty) Ltd Potassium Clavulanate Oral Use 2403 31mg Augmentin BD SF Suspension Amoxicillin 400mg + POM Suspension for 179/046 GlaxoSmithKline SA (Pty) Ltd Potassium Clavulanate Oral Use 2404 59.85mg 2405 Bactroban Ointment Mupirocin 2%w/w POM Cream Topical 179/049 GlaxoSmithKline SA (Pty) Ltd 2406 Eltroxin Tablets Thyroxine 50mcg POM Cream Topical 179/051 GlaxoSmithKline SA (Pty) Ltd Rotarix Liquid Oral Vaccine Live Attenauted Human POM Solution for Oral 179/056 GlaxoSmithKline SA (Pty) Ltd 2407 Rotovirus RIX 4414 Use

Page 124 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Synflorix Vaccine Pneumococcal POM Suspension for 179/057 GlaxoSmithKline SA (Pty) Ltd polysaccharide serotype Injection 1, 4, 5, 6B, 7F, 9V, 14, 2408 18C, 19F & 23F Ventolin Rotacaps Salbutamol 200mcg POM Capsule for 179/058 GlaxoSmithKline SA (Pty) Ltd 2409 Inhalation Aropax 20 Tablets Paroxetine Hydrochloride POM Tablet Uncoated 179/059 GlaxoSmithKline SA (Pty) Ltd Hemihdrate 20mg 2410 Augumentin - 600 Suspension Amoxicillin 600mg + POM Powder for Oral 179/062 GlaxoSmithKline SA (Pty) Ltd 2411 Clavulanic Acid 42.9mg Suspension Cervarix Human Papilomavirus Human Papillomavirus POM Suspension for 179/066 GlaxoSmithKline SA (Pty) Ltd 2412 Vaccine type 16 L1 and 18 L1 Injection Avamys Nasal Spray Fluticasone Furoate POM Spray For Nasal 179/068 GlaxoSmithKline SA (Pty) Ltd 2413 Use Polio Sabin One and Three Oral Poliomyelitis POM Suspension for 179/069 GlaxoSmithKline SA (Pty) Ltd (Oral) Bivalent Oral Poliomyelitis Vaccine Oral Use 2414 Vaccine T Tivicay 50 Tablets Dolutegravir Sodium POM Tablet Film coated 179/075 GlaxoSmithKline SA (Pty) Ltd 2415 50mg Candid B Cream Clotrimazole 1%w/w + POM Cream Topical 093/001 Glenmark Pharmaceuticals Limited, India Beclometasone Dipropionate 0.025 % 2416 w/w. Candid B lotion Clotrimazole 1% w/v + POM Lotion for Topical 093/002 Glenmark Pharmaceuticals Limited, India Beclomethasone Use Dipropionate 0.025% w/v 2417 2418 Candid Cream Clotrimazole 1% w/w POM Cream Topical 093/003 Glenmark Pharmaceuticals Limited, India Candiderm Cream Gentamicin 0.1% w/w + POM Cream Topical 093/004 Glenmark Pharmaceuticals Limited, India Beclometasone Dipropionate 0.025% w/w + Clotrimazole 1% w/w 2419 Candid Dusting Powder Clotrimazole 1% w/w POM Powder for Topical 093/005 Glenmark Pharmaceuticals Limited, India 2420 use Candid Ear Drops Clotrimazole 1% w/v + POM Ear Drops 093/006 Glenmark Pharmaceuticals Limited, India Lignocaine Hydrochloride 2421 2% w/v

Page 125 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Candid lotion Clotrimazole 1% w/v POM Lotion for Topical 093/007 Glenmark Pharmaceuticals Limited, India 2422 Use Candid Mouth Paint Clotrimazole 1%w/v POM Suspension for 093/008 Glenmark Pharmaceuticals Limited, India 2423 Oral Use Candid TV Lotion Selenium sulfide 2.5% POM Lotion for Topical 093/009 Glenmark Pharmaceuticals Limited, India w/v + Clotrimazole 1% Use 2424 w/v 2425 Candid V Gel Clotrimazole 2% w/w POM Gel Vaginal 093/010 Glenmark Pharmaceuticals Limited, India 2426 CandidV-1 Vaginal Tablets Clotrimazole 500mg POM Tablet Vaginal 093/011 Glenmark Pharmaceuticals Limited, India 2427 CandidV-3 Vaginal Tablets Clotrimazole 200mg POM Tablet Vaginal 093/012 Glenmark Pharmaceuticals Limited, India 2428 Candid V-6 Vaginal Tablets Clotrimazole 100mg POM Tablet Vaginal 093/013 Glenmark Pharmaceuticals Limited, India 2429 Diziron Tablets Cinnarizine 25mg POM Tablet Uncoated 093/014 Glenmark Pharmaceuticals Limited, India Scaboma Cream Benzocaine 2% w/w + P Cream Topical 093/015 Glenmark Pharmaceuticals Limited, India 2430 Lindane 2% w/w Scaboma lotion Lindane 1%w/w P Lotion for Topical 093/016 Glenmark Pharmaceuticals Limited, India 2431 Use Supricort Cream Fluocinolone Acetonide POM Cream Topical 093/017 Glenmark Pharmaceuticals Limited, India 2432 0.025% w/w Supricort N Cream Neomycin Sulphate 0.5% POM Cream Topical 093/018 Glenmark Pharmaceuticals Limited, India + Fluocinolone Acetonide 2433 0.025% Supricort Skin lotion Fluocinolone Acetonide POM Lotion for Topical 093/019 Glenmark Pharmaceuticals Limited, India 2434 0.025% Use Syntran DS Tablets Sulphamethoxazole POM Tablet Uncoated 093/020 Glenmark Pharmaceuticals Limited, India 800mg + Trimethoprim 2435 160mg Syntran Paediatric Syrup Sulfamethoxazole 200mg POM Syrup 093/021 Glenmark Pharmaceuticals Limited, India + Trimethoprim 40mg 2436 2437 Vorth 10 Tablets Valdecoxib 10mg POM Tablet Uncoated 093/022 Glenmark Pharmaceuticals Limited, India 2438 Vorth 20 Tablets Valdecoxib 20mg POM Tablet Uncoated 093/023 Glenmark Pharmaceuticals Limited, India 2439 Deriva Aqueous Gel Adapalene 0.1%w/v P Gel Topical 093/024 Glenmark Pharmaceuticals Limited, India 2440 Rosicon-2mg Tablets Rosiglitazone 2mg POM Tablet Uncoated 093/025 Glenmark Pharmaceuticals Limited, India 2441 Rosicon-4 Tablets Rosiglitazone 4mg POM Tablet Uncoated 093/026 Glenmark Pharmaceuticals Limited, India Mumfer Syrup Haematinic preparation P Syrup 093/027 Glenmark Pharmaceuticals Limited, India (Ferric Hydroxide 50mg, 2442 per 5ml)

Page 126 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Mumfer Drops Haematinic preparation P Solution for Oral 093/028 Glenmark Pharmaceuticals Limited, India (Ferric Hydroxide 50mg, Use 2443 per ml) 2444 Esoz Tablets Esomeprazole 20mg POM Tablet Uncoated 093/029 Glenmark Pharmaceuticals Limited, India 2445 Esoz-40 Tablets Esomeprazole 40mg POM Tablets oral 093/030 Glenmark Pharmaceuticals Limited, India 2446 Glevo-250 Tablets Levofloxacin 250mg POM Tablet Uncoated 093/031 Glenmark Pharmaceuticals Limited, India 2447 Glevo-500 Tablets Levofloxacin 500mg POM Tablet Uncoated 093/032 Glenmark Pharmaceuticals Limited, India Glevo 500 Infusion Levofloxacin 500mg POM Solution for 093/033 Glenmark Pharmaceuticals Limited, India 2448 infusion Powercort Cream Clobetasol Propionate POM Cream Topical 093/034 Glenmark Pharmaceuticals Limited, India 2449 0.05% Mumfer Chewable Tablets Haematinic Preparation P Tablet Chewable 093/035 Glenmark Pharmaceuticals Limited, India (Folic Acid 500 mcg + Iron (II) Hydroxide Polymaltose Complex 2450 100mg) Elovera Cream Tecopherol Acetate 0.5% P Cream Topical 093/036 Glenmark Pharmaceuticals Limited, India w/w + Aloe crude extract 2451 10.0 %w/w Relcer Gel Suspension Aluminium Hydroxide 6g P Suspension for 093/038 Glenmark Pharmaceuticals Limited, India + Magnesium Hydroxide Oral Use 80mg + Acitvated Dimethicone 100mg + Deglycyrrhized Liquorice 2452 400 mg/5 mL. 2453 Glenseng Capsules Ginseng extract 500mg GS Capsule oral 093/039 Glenmark Pharmaceuticals Limited, India Ascoril Expectorant Sabutamol Sulphate 2mg POM Solution for Oral 093/040 Glenmark Pharmaceuticals Limited, India + Bromhexine Use Hydrochloride 4mg + Menthol 1mg + Guaiphenesin 100mg, 2454 per 5ml Altacef Suspension Cefuroxime Axetil POM Powder for Oral 093/041 Glenmark Pharmaceuticals Limited, India 2455 125mg, per 5ml Suspension Altacef Tablets Cefuroxime Axetil POM Tablet Film coated 093/042 Glenmark Pharmaceuticals Limited, India 2456 250mg Altacef Tablets Cefuroxime Axetil 500mg POM Tablet Uncoated 093/043 Glenmark Pharmaceuticals Limited, India 2457 2458 Ciproglen Tablets Ciprofloxacin 500mg POM Tablet Uncoated 093/044 Glenmark Pharmaceuticals Limited, India

Page 127 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 2459 Glimulin Tablets Glimepiride 2mg POM Tablet Uncoated 093/045 Glenmark Pharmaceuticals Limited, India 2460 Enamate 10 Tablets Enalapril 10mg POM Tablet Uncoated 093/046 Glenmark Pharmaceuticals Limited, India Altacef 750 Injection Cefuroxime 750mg POM Powder for 093/047 Glenmark Pharmaceuticals Limited, India 2461 Injection Altacef 250mg Injection Cefuroxime 250mg POM Powder for 093/048 Glenmark Pharmaceuticals Limited, India 2462 Injection 2463 Glucar Tablets Acarbose 50mg POM Tablet Uncoated 093/049 Glenmark Pharmaceuticals Limited, India Erythromycin Tablets Erythromycin POM Tablet Film coated 093/050 Glenmark Pharmaceuticals Limited, India 2464 Stearate250mg 2465 Perigard 2 Tablets Perindopril 2mg POM Tablet Uncoated 093/051 Glenmark Pharmaceuticals Limited, India 2466 Perigard 4 Tablets Perindopril 4mg POM Tablet Uncoated 093/052 Glenmark Pharmaceuticals Limited, India 2467 Telma 20 Tablets Telmisartan 20mg POM Tablet Uncoated 093/053 Glenmark Pharmaceuticals Limited, India 2468 Telma 40 Tablets Telmisartan 40mg POM Tablet Uncoated 093/054 Glenmark Pharmaceuticals Limited, India Telma-H Tablets Hydrochlorothiazide POM Tablet Uncoated 093/055 Glenmark Pharmaceuticals Limited, India 12.5mg + Telmisartan 2469 40mg Valus AP Tablets Paracetamol 500mg + P Tablet Uncoated 093/056 Glenmark Pharmaceuticals Limited, India 2470 Aceclofenac 100mg Doxetaxel 80mg Injection Doxetaxel 80mg POM Powder for 093/057 Glenmark Pharmaceuticals Limited, India 2471 Injection Doxetaxel 20mg Injection Doxetaxel 20mg POM Powder for 093/058 Glenmark Pharmaceuticals Limited, India 2472 Injection Irinotecan 100mg Servycal Irinotecan Hydrochloride POM Powder for 093/059 Glenmark Pharmaceuticals Limited, India 2473 Injection Trihydrate 100mg Injection Irinotecan 40mg Servycal Irinotecan Hydrochloride POM Powder for 093/060 Glenmark Pharmaceuticals Limited, India 2474 Injection Trihydrate 40mg Injection Oxaliplatino Servycal 100mg Oxaliplatin 100mg POM Powder for 093/061 Glenmark Pharmaceuticals Limited, India 2475 Injection Injection Oxaliplatino Servycal 50mg Oxaliplatin 50mg POM Powder for 093/062 Glenmark Pharmaceuticals Limited, India 2476 Injection Injection Doxorubicina 50mg Servycal Doxorubicin Vial Vial 093/063 Glenmark Pharmaceuticals Limited, India 2477 Injection Hydrochloride 50mg Doxorubicina 10mg Servycal Doxorubicin POM Powder for 093/064 Glenmark Pharmaceuticals Limited, India 2478 Injection Hydrochloride 10mg Injection Carboplastino Servycal 450mg Carboplatin 450mg POM Powder for 093/065 Glenmark Pharmaceuticals Limited, India 2479 Injection Injection Carboplastino Servycal 150mg Carboplatin 150mg POM Powder for 093/066 Glenmark Pharmaceuticals Limited, India 2480 Injection Injection

Page 128 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Paclitaxel Servycal 30 mg Paclitaxel 30mg POM Powder for 093/067 Glenmark Pharmaceuticals Limited, India 2481 Injection Injection Paclitaxel Servycal 100mg Paclitaxel 100mg POM Powder for 093/068 Glenmark Pharmaceuticals Limited, India 2482 Injection Injection Leucovorina servycal 50mg Leucovorin Calcica 50mg POM Lyophilised 093/069 Glenmark Pharmaceuticals Limited, India Injection concentrate for 2483 Injection Ondansetron Servycal 8mg Ondansetron 8mg, per POM Solution for 093/070 Glenmark Pharmaceuticals Limited, India 2484 Injection 4ml Injection 2485 Supirocin Ointment Mupirocin 2% w/w POM Cream Topical 093/071 Glenmark Pharmaceuticals Limited, India X-met Tablets Metformin Hydrochloride POM Tablet extended 093/072 Glenmark Pharmaceuticals Limited, India 2486 500mg release Ascovent Syrup Acebrophylline 50mg, per P Syrup 093/073 Glenmark Pharmaceuticals Limited, India 2487 5ml Halovate Ointment Halobetasol Propionate POM Ointment topical 093/074 Glenmark Pharmaceuticals Limited, India 2488 0.05%w/w Artiglen+ Tablets Artemether 80mg + POM Tablet Uncoated 093/075 Glenmark Pharmaceuticals Limited, India 2489 Lumefantrine 480mg Artiglen + Dry Syrup 60mls Artemether180mg + POM Powder for Oral 093/076 Glenmark Pharmaceuticals Limited, India 2490 Lumefantrine 1080mg Suspension Beclometasone Pressurised Beclamethasone POM Solution for 093/077 Glenmark Pharmaceuticals Limited, India Inhalation Dipropionate Anhydrous Inhalation 2491 250mcg Relcer Gel Vanilla Flavour Aluminium Hydroxide POM Suspension for 093/078 Glenmark Pharmaceuticals Limited, India 365mg + Magnesium Oral Use Hydroxide 80mg + Simethicone 100mg +Deglycyrrhized 2492 Liquorice 400 mg Relcer Gel Mango Flavour Aluminium Hydroxide POM Suspension for 093/079 Glenmark Pharmaceuticals Limited, India 365mg + Magnesium Oral Use Hydroxide 80mg + Simethicone 100mg +Deglycyrrhized 2493 Liquorice 400 mg

Page 129 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Relcer Gel Strawberry Flavour Aluminium Hydroxide POM Suspension for 093/080 Glenmark Pharmaceuticals Limited, India 365mg + Magnesium Oral Use Hydroxide 80mg + Simethicone 100mg +Deglycyrrhized 2494 Liquorice 400 mg 2495 Flexilor 4 Tablets Lornoxicam 4mg P Tablet Uncoated 093/081 Glenmark Pharmaceuticals Limited, India 2496 Flexilor 8 Tablets Lornoxicam 8mg P Tablet Uncoated 093/082 Glenmark Pharmaceuticals Limited, India Flexilor -SR Tablets Lornoxicam 16mg P Tablet sustained 093/083 Glenmark Pharmaceuticals Limited, India 2497 release Ascoril D Syrup Dextromethorphan P Solution for Oral 093/084 Glenmark Pharmaceuticals Limited, India Hydromide 10.00mg + Use Triprolidine Hydrochloride 1.25mg + Phenylephrine Hydrochloride 30.00mg 2498 Esoz Fast Tablets 20mg Esomeprazole POM Tablet Film coated 093/085 Glenmark Pharmaceuticals Limited, India 2499 Magnesium 20mg Esoz Fast Tablets 40mg Esomeprazole POM Tablet Film coated 093/086 Glenmark Pharmaceuticals Limited, India 2500 Magnesium 40mg Airtec SF 50 Inhaler Salmeterol Xinafoate BP POM Solution for 093/087 Glenmark Pharmaceuticals Limited, India 25mcg + Fluticasone Inhalation 2501 Propionate BP 50mcg Airtec SF-125 Inhaler Salmeterol Xinafoate BP POM Solution for 093/088 Glenmark Pharmaceuticals Limited, India 25mcg + Fluticasone Inhalation 2502 Propionate BP 125mcg Airtec SF 250 Inhaler Salmeterol Xinafoate BP POM Solution for 093/089 Glenmark Pharmaceuticals Limited, India 25mcg + Fluticasone Inhalation 2503 Propionate BP 250mcg Dermikelp Topical Cream Ecklonia maxima extract GS Cream Topical 093/090 Glenmark Pharmaceuticals Limited, India 2504 375mg/g 2505 V Wash Plus Lactic Acid 1.2% w/v GSL Liquid soap 093/091 Glenmark Pharmaceuticals Limited, India Razel 20 Tablets Rosuvastatin (as POM Tablet Uncoated 093/095 Glenmark Pharmaceuticals Limited, India 2506 calcium) 20mg Razel 10 Tablets Rosuvastatin (as POM Tablet Uncoated 093/096 Glenmark Pharmaceuticals Limited, India 2507 calcium) 10mg 2508 Tacroz Forte Ointment Tacrolimus 0.1% w/w POM Ointment topical 093/097 Glenmark Pharmaceuticals Limited, India Glemont - CT4 Tablets Monteleukast Sodium POM Tablet Chewable 093/099 Glenmark Pharmaceuticals Limited, India 2509 4mg

Page 130 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Glemont- CT5 Tablets Monteleukast Sodium POM Tablet Chewable 093/100 Glenmark Pharmaceuticals Limited, India 2510 5mg Demelan 15g Cream Glycolic Acid 100mg + GS Cream Topical 093/101 Glenmark Pharmaceuticals Limited, India Alpha- Albutin 50 mg + 2511 Kojic Dipalmitate 20mg Razel 40 Tablets Rosuvastatin (as POM Tablet Uncoated 093/102 Glenmark Pharmaceuticals Limited, India 2512 Calcium) 40mg 2513 Sensur Lotion Wintergreen oil 12 % w/v GS Lotion for Topical 093/103L Glenmark Pharmaceuticals Limited, India Sensur Rubefacient Mentha+ Peppermint Piperita oil 141 % % w/v GS OintmentUse topical 093/104L Glenmark Pharmaceuticals Limited, India w/w + Eucalyptus Oil 7.5 % w/v + Camphor 14.7 % w/w + Clove Oil 7.8 % v/v + Cinnamon Oil 2 % w/v + Peppermint Oil 8 % 2514 w/v. Sensor Roll Mentha Piperita 14 % w/v GS Solution for Topical 093/105L Glenmark Pharmaceuticals Limited, India + Wintergreen Oil 40 % Use v/v + Camphor 17 % v/v + Eucalyptus Oil 6.5 % 2515 v/v. Burnstart Dressing Medical grade P Paste Topical 027/001L Global Natural Products Aluminosilicate powder 2516 46.5% w/w G-Vit Tablets with Minerals Multivitamin + Minerals P Tablet Uncoated 291/001 Global Pharma Healthcare 2517 Tablets 2518 Rabazole - 20 Tablets Rabeprazole 20mg POM Tablet Uncoated 291/003 Global Pharma Healthcare 2519 D-Lor Tablets Desloratadine 5mg P Tablet Uncoated 291/004 Global Pharma Healthcare 2520 Priloten - 5 Tablets Enalapril 5mg POM Tablet Uncoated 291/005 Global Pharma Healthcare Feramin Tablets Folic Acid 500mg + P Tablet Uncoated 291/002 Global Pharma Healthcare, India Methylcobalamin 50mg + Elemental Iron 1mg + 2521 Zinc 61.8mg TiniTablets- N Tablets Tinidazole 600mg + POM Tablet Uncoated 291/006 Global Pharma Healthcare, India 2522 Norfloxacin 400mg 2523 Anaflam Tablets Ibuprofen 400mg P Tablet Uncoated 291/007 Global Pharma Healthcare, India Tryzin Tablets Cetirizine Dihydrochloride P Tablet Uncoated 291/008 Global Pharma Healthcare, India 2524 10mg

Page 131 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Polybac -N Ointment Bactricine Zinc 5000units POM Ointment topical 291/009 Global Pharma Healthcare, India + Neomycin Sulphate 400units + Polymixin B Su 3400units 2525 Dolmax Gel Diclofenac Sodium P Gel Topical 291/010 Global Pharma Healthcare, India 2526 1%w/w LA - DS Tablets Artemether 40mg + POM Tablet Uncoated 291/011 Global Pharma Healthcare, India 2527 Lumefantrine 240mg 2528 Ferrous Sulphate Tablets Ferrous Sulphate 200mg POM Tablet Uncoated 221/001 Glow Export Trading Pvt Ltd, India Cetrol ORS Powder Sodium Chloride 3.5g + POM Powder for Oral 221/002 Glow Export Trading Pvt Ltd, India Sodium Citrate 2.9g + Solution Potassium Chloride 1.5g + Anhydrous Glucose 2529 20g 2530 Artesunate Tablets Artesunate 100mg POM Tablet Uncoated 221/003 Glow Export Trading Pvt Ltd, India 2531 G-Prop Tablets Propranolol 40mg POM Tablet Uncoated 221/004 Glow Export Trading Pvt Ltd, India Pharmadar Tablets Sulphadoxine 500mg + P Tablet Uncoated 169/001 Glumex Pharmaceuticals (Pvt) Ltd, India 2532 Pyrimethamine 25mg Eryomycin Syrup Erythromycin 125mg, per POM Syrup 169/002 Glumex Pharmaceuticals (Pvt) Ltd, India 2533 5ml C.P.Mex Syrup Chlorpheniramine 2mg, P Syrup 169/003 Glumex Pharmaceuticals (Pvt) Ltd, India 2534 per 5ml Glucain Tablets Aluminium Hydrochloride GS Tablet Uncoated 169/004 Glumex Pharmaceuticals (Pvt) Ltd, India 120mg + Magnesium 2535 trisilicate 250 mg Pharmadar Suspension Sulphadoxine 250 mg + P Suspension for 169/005 Glumex Pharmaceuticals (Pvt) Ltd, India 2536 Pyrimethamine 12.50mg Oral Use 2537 Biovit-Z-Syrup Multivitamins + Minerals P Syrup 169/006 Glumex Pharmaceuticals (Pvt) Ltd, India Cold care Tablets Chlorpheniramine 2mg + P Tablet Uncoated 169/007 Glumex Pharmaceuticals (Pvt) Ltd, India Caffeine 30mg + 2538 Paracetamol 500mg 2539 Gluvit Syrup Multivitamins + Minerals GS Syrup 169/008 Glumex Pharmaceuticals (Pvt) Ltd, India 2540 Lopamet Capsules Loperamide 2mg POM Capsule oral 169/010 Glumex Pharmaceuticals (Pvt) Ltd, India 2541 Apectin Tablets Cyproheptadine 4mg P Tablet Uncoated 169/011 Glumex Pharmaceuticals (Pvt) Ltd, India Clopin Syrup Ampicillin 125mg + POM Powder for Oral 169/012 Glumex Pharmaceuticals (Pvt) Ltd, India Cloxacillin 125mg, per Solution 2542 5ml

Page 132 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Cephamex Syrup Cephalexin 125mg, per POM Powder for Oral 169/013 Glumex Pharmaceuticals (Pvt) Ltd, India 2543 5ml Solution 2544 Flucomex Capsules Fluconazole 200mg POM Capsule oral 169/014 Glumex Pharmaceuticals (Pvt) Ltd, India 2545 Eromycin Tablets Erythromycin 250mg POM Tablet Uncoated 169/015 Glumex Pharmaceuticals (Pvt) Ltd, India Amizide Tablets Hydrochlorothiazide POM Tablet Uncoated 169/017 Glumex Pharmaceuticals (Pvt) Ltd, India 50mg + Amiloride 2546 Hydrochloride 5mg 2547 Methyldopa Tablets Methyldopa 250mg POM Tablet Uncoated 169/018 Glumex Pharmaceuticals (Pvt) Ltd, India 2548 Zovex Tablets Acyclovir 200mg POM Tablet Uncoated 169/019 Glumex Pharmaceuticals (Pvt) Ltd, India 2549 Carbamax Tablets Carbamazepine 200mg POM Tablets 169/020 Glumex Pharmaceuticals (Pvt) Ltd, India 2550 Paracetamol Tablets Paracetamol 500mg GS Tablet Uncoated 169/021 Glumex Pharmaceuticals (Pvt) Ltd, India 2551 Pyridoxine Tablets Pyridoxine 50mg POM Tablet Uncoated 169/022 Glumex Pharmaceuticals (Pvt) Ltd, India Nalidiixic Acid Oral Suspension Nalidixic acid 300mg, per POM Oral Suspension 169/023 Glumex Pharmaceuticals (Pvt) Ltd, India 2552 5ml 2553 Aminophylline Tablets Aminophylline 100mg POM Tablet Uncoated 169/024 Glumex Pharmaceuticals (Pvt) Ltd, India 2554 Glibenclamide Tablets Glibenclamide 5mg POM Tablet Uncoated 169/025 Glumex Pharmaceuticals (Pvt) Ltd, India 2555 Viengray Tablets Sildenafil 50mg POM Tablet Uncoated 169/026 Glumex Pharmaceuticals (Pvt) Ltd, India Apectine Syrup Cyproheptidine 2mg, per P Syrup 169/027 Glumex Pharmaceuticals (Pvt) Ltd, India 2556 5ml Ebut Capsules Paracetamol 325mg + P Capsule oral 169/028 Glumex Pharmaceuticals (Pvt) Ltd, India Ibuprofen 200mg + 2557 Caffeine 40mg Polyinosinic-polycytidylic Acid Polyinosinic-polycytidylic POM Solution for 261/001 Guangdong Bang Min Pharmaceutical Co. 2558 Injection acid 2mg, per 2ml Injection Ltd,China Artescore for Children Tablets Pyrimethamine 25mg + POM Tablet Uncoated 043/001 Guilin Pharmaceuticals Co Ltd,China Artesunate 50mg + 2559 Sulfadoxine 500mg Artescore Tablets Artesunate 100 + POM Tablet Uncoated 043/002 Guilin Pharmaceuticals Co Ltd,China Sulfadoxine 500 + 2560 Pyrimethamine 25mg Artesun 60 Injection Artesunate 60mg POM Solution for 043/003 Guilin Pharmaceuticals Co Ltd,China 2561 Injection 2562 G - Abzole Tablets Albendazole 400mg POM Tablet Uncoated 043/004 Guilin Pharmaceuticals Co Ltd,China G-ciprox Tablets Ciprofloxacin 500mg POM Tablet Enteric 043/005 Guilin Pharmaceuticals Co Ltd,China 2563 Coated Sulphamethoxazole 800mg+ Sulfamethoxazole 800mg POM Tablet Uncoated 043/006 Guilin Pharmaceuticals Co Ltd,China Trimethoprim 160mg USP + Trimethoprim 160mg 2564 Tablets

Page 133 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Sulphamethoxazole 400mg+ Sulfamethoxazole 400mg POM Tablet Uncoated 043/007 Guilin Pharmaceuticals Co Ltd,China Trimethoprim 80mg USP + Trimethoprim 160mg 2565 Tablets Artesun Injection 30mg Artesunate 30mg POM Solution for 043/008 Guilin Pharmaceuticals Co Ltd,China 2566 Injection Artesun Injection 120mg Artesunate 120mg POM Solution for 043/009 Guilin Pharmaceuticals Co Ltd,China 2567 Injection Dufenac 75mg Dual Release Diclofenac Sodium 75mg P Caplets oral Enteric 043/019 Guilin Pharmaceuticals Co Ltd,China 2568 Enteric Capsules Coated Zathenza Powder for Injection Benzathin 2.4 mega units POM Powder for 043/020 Guilin Pharmaceuticals Co Ltd,China 2569 Injection G-Cospe Tablets Sulfadoxine 500mg + POM Tablet Uncoated 043/010 Guilin Pharmaceuticals Co. Ltd, China 2570 Pyrimethamine 25mg G-Ceftria Injection Ceftriaxone Sodium 1.0g POM Powder for 043/011 Guilin Pharmaceuticals Co. Ltd, China 2571 Injection D-Artepp Tablets Dihydroartemisinin 40mg POM Tablet Uncoated 043/012 Guilin Pharmaceuticals Co. Ltd, China + Piperaquine Phosphate 2572 320mg Ferro Booster Capsules Iron 100mg + Vitamin C P Capsule oral 360/001 Hanson canada 75mg + Zinc 22.5mg + Folic Acid 1.5mg + Selenium 60mcg + Vit 2573 B12 5mcg + Vit E 15I.U Rejuvin Tablets Methylcobalamin 500 P Tablet Uncoated 360/002 Hanson canada mcg +Vitamin A (as 2574 acetate) 5000IU + Asc Miracle Detox Tablets Biotin USP 100mcg + P Tablet Uncoated 360/003 Hanson canada Calcium D Pantothenate 2575 BP 10mg + Folic A 2576 Omega 369 Capsules Flax Seed Oil 500mg P Capsule oral 360/004 Hanson canada Povidone Iodine Topical Povidone Iodine USP P Solution for Topical 360/005L Hanson canada 2577 Solution 5%w/v Use Alatrol Tablets Cetirizine Hydrochloride P Tablet Uncoated 345/001 Hasafa Health Sciences,Tanzania 2578 10mg Anadol 100 Injection Tramadol Hydrochloride POM Solution for 345/002 Hasafa Health Sciences,Tanzania 2579 100mg Injection Osmolax Oral Solution Lactulose 3.4mg, per 5ml P Solution for Oral 345/003 Hasafa Health Sciences,Tanzania 2580 Use

Page 134 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Trupan 20 Tablets Pantoprazole Sodium POM Tablet Film coated 345/004 Hasafa Health Sciences,Tanzania 2581 20mg Zimax 500 Tablets Azithromycin Dihydrate POM Tablet Uncoated 345/005 Hasafa Health Sciences,Tanzania 2582 500mg 2583 Hecmetro 200 Tablets Metronidazole 200mg POM Tablet Film coated 190/002 Healthy Life Pharma (Pvt) Ltd, India 2584 Jantrax Tablets Levamisole 40mg P Tablet Film coated 190/003 Healthy Life Pharma (Pvt) Ltd, India Trimoxazole Oral Suspension Trimethoprim 40mg + POM Suspension for 190/005 Healthy Life Pharma (Pvt) Ltd, India Sulphamethoxazole Oral Use 2585 200mg Chloramphenicol Sodium Chloramphenicol 1g, per POM Powder for 190/013 Healthy Life Pharma (Pvt) Ltd, India 2586 Injection 10ml Injection 2587 Indometacin Capsules Indomethacin 25mg P Capsule oral 190/019 Healthy Life Pharma (Pvt) Ltd, India Amoxicillin Oral Suspension Amoxicillin 125mg, per POM Suspension for 190/020 Healthy Life Pharma (Pvt) Ltd, India 2588 5ml Oral Use 2589 Vita+ Iron Tablets Multivitamins + Iron P Tablet Uncoated 190/022 Healthy Life Pharma (Pvt) Ltd, India 2590 Folic Acid 5mg Tablets Folic acid 5mg P Tablet Uncoated 292/001 Hebei Jiheng Pharmaceuticals Co Limited 2591 Paracare 500 Tablets Paracetamol 500mg GS Tablet Uncoated 292/002 Hebei Jiheng Pharmaceuticals Co Limited Rapid 1-2-3 Hema HIV Whole Diagnostic Test Kits P HDPE Strips 021/001L Hema Diagnostic Systems, USA 2592 Format Test Kit Rapid 1-2-3 Hema express HIV Diagnostic Test Kits P HDPE Strips 021/002L Hema Diagnostic Systems, USA 2593 (Whole Blood) Kit Rapid 1-2-3 Hema express HIV Diagnostic Test Kits P HDPE Strips 021/003L Hema Diagnostic Systems, USA (Serum/Plasma) Strip Format 2594 Test Kit Rapid 1-2-3 Hema express HIV Diagnostic Test Kits P HDPE Strips 021/004L Hema Diagnostic Systems, USA 2595 (Serum/Plasma) Test Kit Rapid 1-2-3 Hema Syphilis Diagnostic Test Kits P HDPE Strips 021/005L Hema Diagnostic Systems, USA 2596 Dipstick Test Kit Rapid 1-2-3 Hema express Diagnostic Test Kits P HDPE Strips 021/006L Hema Diagnostic Systems, USA 2597 Syphilis Test Rapid 1-2-3 Hema Malaria Diagnostic Test Kits P HDPE Strips 021/007L Hema Diagnostic Systems, USA Plasmodium Falciparum(pf)Strip Format Test K 2598 Rapid 1-2-3 Hema Malaria Diagnostic Test Kits P HDPE Strips 021/008L Hema Diagnostic Systems, USA Plasmodium Falciparum(pf)Strip Format Test K 2599

Page 135 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Rapid 1-2-3 Hema Malaria 9pf Diagnostic Test Kits P HDPE Strips 021/009L Hema Diagnostic Systems, USA 2600 Dipstick Test Rapid 1-2-3 Hema express Diagnostic Test Kits P HDPE Strips 021/010L Hema Diagnostic Systems, USA Malaria Plasmodium 2601 Falciparum/Plasmodium Vivax Rapid 1-2-3 Hema Malaria Diagnostic Test Kits P HDPE Strips 021/011L Hema Diagnostic Systems, USA Dipstick Test for Multiple 2602 Malaria Species Rapid 1-2-3 Hema express Diagnostic Test Kits P HDPE Strips 021/012L Hema Diagnostic Systems, USA 2603 Malaria pfv-Multiple Test 2604 Zido-H 300 Tablets Zidovudine 300mg POM Tablet Uncoated 150/001 Hetero Drugs Limited, India 2605 Heptavir 150 Tablets Lamivudine 150mg POM Tablet Uncoated 150/002 Hetero Drugs Limited, India 2606 Indivir -400 Capsules Indinavir 400mg POM Capsule oral 150/003 Hetero Drugs Limited, India 2607 Nevivir 200 Tablets Nevirapine 200mg POM Tablet Uncoated 150/006 Hetero Drugs Limited, India Zidolam Tablets Lamivudine 150mg + POM Tablet Uncoated 150/007 Hetero Drugs Limited, India 2608 Zidovudine 300mg Nevilast 30 Tablets Lamivudine 150mg + POM Tablet Uncoated 150/008 Hetero Drugs Limited, India Nevirapine 200mg + 2609 Stavudine 30mg Nevilast - 40 Tablets Lamivudine 150mg + POM Tablet Uncoated 150/009 Hetero Drugs Limited, India Nevirapine 200mg + 2610 Stavudine 40mg Zidolam-N Tablets Zidovudine 300mg + POM Tablet Uncoated 150/010 Hetero Drugs Limited, India Lamivudine 150mg + 2611 Nevirapine 200mg 2612 Estiva-600 Tablets Efavirenz 600mg POM Tablet Uncoated 150/011 Hetero Drugs Limited, India 2613 Ciproplus -250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 150/012 Hetero Drugs Limited, India 2614 Ciproplus 500mg Tablets Ciprofloxacin 500mg POM Tablet Uncoated 150/013 Hetero Drugs Limited, India 2615 Clarigen 250mg Tablets Clarithromycin 250mg POM Tablet Uncoated 150/014 Hetero Drugs Limited, India 2616 Clarigen 500mg Tablets Clarithromycin 500mg POM Tablet Uncoated 150/015 Hetero Drugs Limited, India Tenof Tablets Tenofivir disoproxil POM Tablet Uncoated 150/018 Hetero Drugs Limited, India 2617 fumurate 300mg Tenolam Tablets Tenofivir Disoproxil POM Tablet Uncoated 150/022 Hetero Drugs Limited, India Fumurate 300mg + 2618 Lamivudine 300mg Efavirenz/Emtricitabine/Tenofivir Efavirenz 600mg + POM Tablet Film coated 150/023 Hetero Drugs Limited, India Tablets Emtricitabine 200mg + Tenofivir Disoproxil 2619 Fumurate 300mg

Page 136 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Lopinavir & Ritonavir Lopinavir 200mg + POM Tablet Film coated 150/024 Hetero Drugs Limited, India 2620 200mg/50mg Tablets Ritonavir50mg Amlo - H 10 Tablets Amlodipine Besylate POM Tablet Uncoated 150/025 Hetero Drugs Limited, India 2621 10mg Amlo - H 5 Tablets Amlodipine Besylate 5mg POM Tablet Uncoated 150/026 Hetero Drugs Limited, India 2622 Gemtero 1g Injection Gemcitabine POM Solution for 150/027 Hetero Drugs Limited, India 2623 Hydrochloride 1g Injection Gemtero 200mg Injection Gemcitabine POM Solution for 150/028 Hetero Drugs Limited, India 2624 Hydrochloride 200 mg Injection Levin 500 Tablets Levofloxacin POM Tablet Uncoated 150/029 Hetero Drugs Limited, India 2625 Hemihydrate 500mg Levin 250 Tablets Levofloxacin POM Tablet Uncoated 150/030 Hetero Drugs Limited, India 2626 Hemihydrate 250mg 2627 Penvir-750 Tablets Famcyclovir 750mg POM Tablet Film coated 150/031 Hetero Drugs Limited, India 2628 Penvir-250 Tablets Famcyclovir 250mg POM Tablet Film coated 150/033 Hetero Drugs Limited, India 2629 Irbis-H 300 Tablets Irbesartan 300mg POM Tablet Uncoated 150/035 Hetero Drugs Limited, India 2630 Irbis-H 150 Tablets Irbesartan 150mg POM Tablet Uncoated 150/036 Hetero Drugs Limited, India Atazanavir + Ritonavir Tablets Atazanavir Sulphate POM Tablet Film coated 150/038 Hetero Drugs Limited, India 300mg + Ritonivir 100mg 2631 Emtricitabine & Tenofivir Emtricitabine 200mg + POM Tablet Film coated 150/039 Hetero Drugs Limited, India Disoproxil Fumarate Tablets Tenofivir Disoproxil 2632 Fumarate300mg 2633 Acyclovir Tablets Acyclovir 200mg POM Tablet Uncoated 150/040 Hetero Drugs Limited, India 2634 Flugen-150 Tablets Fluconazole 150mg POM Tablet Uncoated 150/041 Hetero Drugs Limited, India 2635 Flugen 200 Tablets Fluconazole 200mg POM Tablet Uncoated 150/042 Hetero Drugs Limited, India 2636 Giagra 100 Tablets Sildenafil Citrate 100mg POM Tablet Uncoated 150/043 Hetero Drugs Limited, India 2637 Giagra 50 Tablets Sildenafil Citrate 50mg POM Tablet Uncoated 150/044 Hetero Drugs Limited, India Lamivudine Oral Solution Lamivudine 10mg, per ml POM Syrup 150/045 Hetero Drugs Limited, India 2638 Abacavir Sulphate 300mg Abacavir Sulphate 300mg POM Tablet Uncoated 150/046 Hetero Drugs Limited, India 2639 Tablets 2640 Anatero Tablets Anastrozole 1mg POM Tablet Uncoated 150/047 Hetero Drugs Limited, India Efavirenz/Lamivudine/Tenofovir Efavirenz 600mg + POM Tablet Uncoated 150/048 Hetero Drugs Limited, India Tablets Lamivudine 300mg + Tenofivir Disoproxil 2641 Fumurate 300mg

Page 137 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Diclofenac Sodium Delayed Diclofernac Sodium 50 P Capsule oral 150/049 Hetero Drugs Limited, India 2642 Release Tablets mg 2643 Omegenix 20 Capsules Omeprazole 20mg POM Capsule oral 150/050 Hetero Drugs Limited, India 2644 Ibuprofen Tablets 400mg Ibuprofen 400mg P Tablet oral 150/051 Hetero Drugs Limited, India 2645 Bicatero 50 Tablets Bicalutamide 50mg POM Tablet Uncoated 150/052 Hetero Drugs Limited, India 2646 Binfin 5 Tablets Finastride 5mg POM Tablet oral 150/053 Hetero Drugs Limited, India 2647 Zolid Tablets Linezolid 600mg POM Tablet Uncoated 150/054 Hetero Drugs Limited, India Abacavir Sulphate and Abacavir sulphate 600mg POM Tablet Film coated 150/056 Hetero Drugs Limited, India Lamivudine Tablets + Lamivudine 300mg 2648 POM Solution for 150/057 Paclitero 300 Injection Paclitaxel 300mg Hetero Drugs Limited, India 2649 Injection Montelukast Sodium POM 150/059 Monte H 4 Tablets Tablet Film Coated Hetero Drugs Limited, India 2650 4mg Montelukast Sodium POM 150/060 Monte H 5 Tablets Tablet Film Coated Hetero Drugs Limited, India 2651 5mg Montelukast Sodium POM 150/061 Monte H 10 Tablets Tablet Film Coated Hetero Drugs Limited, India 2652 10mg Ferrich Syrup Ferric Ammonium Citrate P Syrup 150/062L Hetero Drugs Limited, India + Folic acid BP + 2653 Cyanocobalamin 2654 Sofgen Tablets Sofosbuvir 400mg POM Tablet Uncoated 150/064 Hetero Drugs Limited, India 2655 Prega 150 Capsules Pregabalin 150mg POM Capsule oral 150/065 Hetero Drugs Limited, India Tecavir 0.5 Tablets Entecavir monohydrate POM Tablet Uncoated 150/066 Hetero Drugs Limited, India 2656 0.5mg Tecavir 1 Tablets Entecavir monohydrate POM Tablet Uncoated 150/067 Hetero Drugs Limited, India 2657 1mg Zoldro 4mg Injection Zoledronic Acid POM Solution for 150/068 Hetero Drugs Limited, India 2658 Monohydrate 4mg Injection 2659 Cycloz Ophthalmic Ointment Acyclovir 5% w/w POM Eye Ointment 157/001 Highnoon Laboratories Ltd, Pakistan 2660 Cycloz Cream Acyclovir 5%w/w POM Cream Topical 157/002 Highnoon Laboratories Ltd, Pakistan 2661 Cycloz Tablets Acyclovir 200mg POM Tablet Uncoated 157/003 Highnoon Laboratories Ltd, Pakistan Loprin 75 mg Tablets Acetyl Salicylic Acid P Tablet Uncoated 157/004 Highnoon Laboratories Ltd, Pakistan 2662 75mg Loprin 150mg Tablets Acetyl Salicylic Acid P Tablet Uncoated 157/005 Highnoon Laboratories Ltd, Pakistan 2663 150mg Loprin 300mg Tablets Acetyl Salicylic Acid P Tablet Uncoated 157/006 Highnoon Laboratories Ltd, Pakistan 2664 300mg

Page 138 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Evacef Suspension Cefadroxil Monohydrate POM Suspension for 157/007 Highnoon Laboratories Ltd, Pakistan 2665 125mg, per 5ml Oral Use Evacef Suspension Cefadroxil Monohydrate POM Suspension for 157/008 Highnoon Laboratories Ltd, Pakistan 2666 250mg, per 5ml Oral Use Tramadol Injection Tramadol Hydrochloride POM Solution for 157/009 Highnoon Laboratories Ltd, Pakistan 2667 100mg, per ml Injection 2668 Griseofulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 157/010 Highnoon Laboratories Ltd, Pakistan Ciprofloxacin Tablets Ciprofloxacin POM Tablet Uncoated 157/011 Highnoon Laboratories Ltd, Pakistan 2669 Hydrochloride 250mg 2670 Cyprocin Tablets Ciprofloxacin 500mg POM Tablet Uncoated 157/012 Highnoon Laboratories Ltd, Pakistan Tamadol Capsules Tramadol Hydrochloride P Capsule oral 157/013 Highnoon Laboratories Ltd, Pakistan 2671 50mg Tamadol Injection Tramadol Hydrochloride POM Solution for 157/014 Highnoon Laboratories Ltd, Pakistan 2672 100mg, per 2ml Injection Beprosone Cream Betamethasone POM Cream Topical 146/001 Hoe Pharmaceuticals Sdn Bud, Malaysia Dipropionate 0.064%w/w 2673 Beprosone Ointment Betamethasone POM Ointment topical 146/002 Hoe Pharmaceuticals Sdn Bud, Malaysia Dipropionate 0.064%w/w 2674 BeproGel Topical Solution Betamethasone POM Solution for Topical 146/003 Hoe Pharmaceuticals Sdn Bud, Malaysia 2675 Dipropionate 0.064%w/v Use Beprosalic Ointment Salicylic acid 3% + POM Ointment topical 146/004 Hoe Pharmaceuticals Sdn Bud, Malaysia Betamethasone Dipropionate 0.064%w/w 2676 Cloderm Cream Clobetasol Propionate POM Cream Topical 146/005 Hoe Pharmaceuticals Sdn Bud, Malaysia 2677 0.0568%w/w Cloderm Ointment Clobetasol Propionate POM Ointment topical 146/006 Hoe Pharmaceuticals Sdn Bud, Malaysia 2678 0.0568%w/v Cloderm Scalp Application Clobetasol Propionate POM Solution for Topical 146/007 Hoe Pharmaceuticals Sdn Bud, Malaysia 2679 Solution 0.0568%w/v Use 2680 Candazole Cream Clotrimazole 1%w/v POM Cream Topical 146/008 Hoe Pharmaceuticals Sdn Bud, Malaysia Candazole lotion Clotrimazole 1%w/v POM Lotion for Topical 146/009 Hoe Pharmaceuticals Sdn Bud, Malaysia 2681 Use Candacort Cream Hydrocortisone 10mg + POM Cream Topical 146/010 Hoe Pharmaceuticals Sdn Bud, Malaysia 2682 Clotrimazole 10 mg

Page 139 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Ecocort Cream Triamcinolone Acetonide POM Cream Topical 146/011 Hoe Pharmaceuticals Sdn Bud, Malaysia 0.1%w/w + Econazole 2683 1%w/w 2684 Dezor Cream Ketoconazole 2.0 %w/w POM Cream Topical 146/012 Hoe Pharmaceuticals Sdn Bud, Malaysia 2685 Dezor Shampoo Ketoconazole 2%w/v POM Shampoo 146/013 Hoe Pharmaceuticals Sdn Bud, Malaysia Decozol Cream Miconazole Nitrate 2% POM Cream Topical 146/014 Hoe Pharmaceuticals Sdn Bud, Malaysia 2686 w/w Decocort Cream Hydrocortisone 1% w/w + POM Cream Topical 146/015 Hoe Pharmaceuticals Sdn Bud, Malaysia Miconazole Nitrate 2.0% 2687 w/w Tolnaderm lotion Tolnaftate 1% w/v POM Lotion for Topical 146/017 Hoe Pharmaceuticals Sdn Bud, Malaysia 2688 Use 2689 Foban Cream Fusidic acid 2% w/w POM Cream Topical 146/018 Hoe Pharmaceuticals Sdn Bud, Malaysia 2690 Foban Ointment Sodium Fusidate 2%w/w POM Ointment topical 146/019 Hoe Pharmaceuticals Sdn Bud, Malaysia Fobancort Ointment Betamethasone POM Ointment topical 146/020 Hoe Pharmaceuticals Sdn Bud, Malaysia Dipropionate 0.064% w/w + Sodium 2691 Fusidate2.0% w/w 2692 Declovir Cream Acyclovir 5% w/w POM Cream Topical 146/021 Hoe Pharmaceuticals Sdn Bud, Malaysia A-Lices Shampoo Malathion 1.0% w/v POM Solution for Topical 146/022 Hoe Pharmaceuticals Sdn Bud, Malaysia 2693 Use Gentamicin Cream Gentamicin Sulphate POM Cream Topical 146/023 Hoe Pharmaceuticals Sdn Bud, Malaysia 2694 0.17%w/w Beprosalic lotion Betamethasone POM Lotion for Topical 146/024 Hoe Pharmaceuticals Sdn Bud, Malaysia Dipropionate 0.064% w/v Use + Salicyclic acid 2%w/v 2695 Poviderm Ointment Povidone Iodine 10%w/w GS Ointment topical 146/027 Hoe Pharmaceuticals Sdn Bud, Malaysia 2696 2697 U-closone Ointment Clobetasone 0.05% POM Ointment topical 146/028 Hoe Pharmaceuticals Sdn Bud, Malaysia Menzze Cream Methyl salicylate 25%w/w GS Cream Topical 146/029 Hoe Pharmaceuticals Sdn Bud, Malaysia 2698 Zellox-DS Suspension Aluminium Hydroxide + P Suspension for 146/030 Hoe Pharmaceuticals Sdn Bud, Malaysia 2699 Simethicone Oral Use 2700 Rhuma Gel Piroxicam 0.5% POM Gel Topical 146/031 Hoe Pharmaceuticals Sdn Bud, Malaysia 2701 C-mycin Gel Clindamycin 1.2% POM Gel Topical 146/032 Hoe Pharmaceuticals Sdn Bud, Malaysia C-mycin lotion Clindamycin 1.2% POM Lotion for Topical 146/033 Hoe Pharmaceuticals Sdn Bud, Malaysia 2702 Use 2703 H-cort Ointment Hydrocortisone 1% POM Ointment topical 146/034 Hoe Pharmaceuticals Sdn Bud, Malaysia

Page 140 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Beprogent Cream Betamethasone + POM Cream Topical 146/035 Hoe Pharmaceuticals Sdn Bud, Malaysia 2704 Gentamycin Oxy-nase 0.05% Nasal Spray Oxymetazoline 0.05% POM Spray For Nasal 146/036 Hoe Pharmaceuticals Sdn Bud, Malaysia 2705 Use 2706 Oxy-nase Drops Oxymetazoline 0.025% POM Nasal drops 146/037 Hoe Pharmaceuticals Sdn Bud, Malaysia Oxy-Nase 0.025% Nasal Spray Oxymetazoline 0.025% POM Spray For Nasal 146/038 Hoe Pharmaceuticals Sdn Bud, Malaysia 2707 Use U-closone Cream Clobetasone Butyrate POM Cream Topical 146/039 Hoe Pharmaceuticals Sdn Bud, Malaysia 2708 0.05% w/w OrrePaste Oral Paste Triamcinolone Acetonide POM Oral paste 146/040 Hoe Pharmaceuticals Sdn Bud, Malaysia 2709 0.1% Oxy-Nase 0.025% Nasal Drops Oxymetazoline P Solution for Topical 146/041 Hoe Pharmaceuticals Sdn Bud, Malaysia Hydrochloride Use 2710 0.025%w/v Fobancort Cream Fusidic acid 2% w/w POM Cream Topical 146/042 Hoe Pharmaceuticals Sdn Bud, Malaysia Dipropionate + Betamethasone Dipropionate 0.064% w/w 2711 2712 Paracetamol 500mg Tablets Paracetamol 500mg GS Tablet Uncoated 059/001 Holden Medicals B.V, The Netherlands Acetyl Salicylic Acid Acetyl Salicylic acid P Tablet Uncoated 059/002 Holden Medicals B.V, The Netherlands 2713 300mg 2714 Folic Acid Tablets Folic acid 5mg P Tablet Uncoated 059/003 Holden Medicals B.V, The Netherlands 2715 Ferrous Sulphate Tablets Ferrous sulphate 200mg P Tablet Film coated 059/004 Holden Medicals B.V, The Netherlands Oral Rehydration Salt Sodium Chloride 3.5g + GS Powder for Oral 059/005 Holden Medicals B.V, The Netherlands Sodium Citrate 2.9g + Solution Potassium Chloride 1.5g + Anhydrous Glucose 2716 20g 2717 Albendazole Albendazole 400mg POM Tablet Uncoated 059/006 Holden Medicals B.V, The Netherlands 2718 Tetracycline Eye Ointment Tetracycline 1% w/w POM Eye Ointment 059/007 Holden Medicals B.V, The Netherlands 2719 Paracetamol 100mg Tablets Paracetamol 100mg GS Tablet Uncoated 059/008 Holden Medicals B.V, The Netherlands Mebendazole 500mg Chewable Mebendazole 500mg P Tablet Uncoated 059/009 Holden Medicals B.V, The Netherlands 2720 Tablets 2721 Hope C Tablets Chlorpheniramine 4mg P Tablet Uncoated 087/005 Hope Pharmaceuticals Hope - C Syrup Chlorpheniramine 2mg, P Syrup 087/006 Hope Pharmaceuticals 2722 per 5ml 2723 Hope-O Capsules Omeprazole 20mg POM Capsule oral 087/009 Hope Pharmaceuticals

Page 141 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 4CC Syrup Paracetamol 120mg + P Syrup 087/001 Hope Pharmaceuticals Limited Phenylepherine Hydrochloride 2.5mg + Dextromethophan 2.00mg + Chlorpheniramine 2724 0.50mg, per 5ml 2725 Blue Strength Tablets Sildenafil 50mg POM Tablet Uncoated 087/002 Hope Pharmaceuticals Limited DIABEST Suspension Metronidazole 100mg + POM Suspension for 087/003 Hope Pharmaceuticals Limited 2726 Furazolidone 30mg Oral Use DIAFREE Suspension Metronidazole 100mg + POM Suspension for 087/004 Hope Pharmaceuticals Limited 2727 Norfloxacin 100mg Oral Use Hopedom Suspension Domperidone 5mg, per POM Suspension for 087/007 Hope Pharmaceuticals, India 2728 5ml Oral Use 2729 Hopedom Tablets Domperidone 10mg POM Tablet Uncoated 087/008 Hope Pharmaceuticals, India Hopenac Tablets Diclofenac sodium POM Tablet Film coated 087/010 Hope Pharmaceuticals, India 2730 100mg I-Plus Tablets Ibuprofen 400mg + P Tablet Uncoated 087/011 Hope Pharmaceuticals, India 2731 Paracetamol 500mg 2732 Cloveg Tablets Clotrimazole 100mg POM Tablet Uncoated 225/001 Household Pharmaceuticals Ltd, India 2733 Cloveg 1%Cream Clotrimazole 1.0%w/w POM Cream Topical 225/002 Household Pharmaceuticals Ltd, India Trioderm Cream Gentamycin 0.1% w/w + POM Cream Topical 225/003 Household Pharmaceuticals Ltd, India Fluocinolone Acetonide 0.01% w/w + Miconazole 2734 2% w/w Ampigran Granules for Ampicillin 125mg, per POM Granules for 173/001 Hovid Sdn Bhd, Malaysia 2735 Suspension 5ml Suspension 2736 Griseofulvin 500 Tablets Griseofulvin 500mg POM Tablet Uncoated 173/002 Hovid Sdn Bhd, Malaysia 2737 Nutrivit Syrup Multivitamins GS Syrup 173/003 Hovid Sdn Bhd, Malaysia 2738 Hostan 250 Capsules Mefenamic Acid 250mg P Capsule oral 173/004 Hovid Sdn Bhd, Malaysia 2739 Prozotab Tablets Prazosin 1mg POM Tablet Uncoated 173/006 Hovid Sdn Bhd, Malaysia Amoxiclav 625 Tablets Amoxicillin 500mg + POM Tablet Film coated 173/007 Hovid Sdn Bhd, Malaysia 2740 Clavulanic Acid 125mg 2741 Nizole Tablets Metronidazole 200mg POM Tablet Uncoated 173/008 Hovid Sdn Bhd, Malaysia 2742 Feloxicam 20 Capsules Piroxicam 20mg POM Capsule oral 173/009 Hovid Sdn Bhd, Malaysia 2743 Clofenac SR Tablets Diclofenac 100mg P Tablet Film coated 173/010 Hovid Sdn Bhd, Malaysia Clofenac 50 SR Tablets Diclofenac 50mg P Tablet sustained 173/011 Hovid Sdn Bhd, Malaysia 2744 release 2745 Amoxicap 250mg Capsules Amoxicillin 250mg POM Capsule oral 173/012 Hovid Sdn Bhd, Malaysia

Page 142 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Suprim 480 Tablets Trimethoprim 80mg + POM Tablet Uncoated 173/013 Hovid Sdn Bhd, Malaysia Sulphamethoxazole 2746 400mg Thelmin Tablets Pyrantel Pamoate 125mg P Tablet Film coated 173/014 Hovid Sdn Bhd, Malaysia 2747 2748 Ternolol Tablets Atenolol 100mg POM Tablet Uncoated 173/015 Hovid Sdn Bhd, Malaysia Chloramphenicol Eye Drops Chloramphenicol 0.5% POM Eye Drops 173/016 Hovid Sdn Bhd, Malaysia 2749 w/v 2750 Ternolol 50 Tablets Atenolol 50mg POM Tablet Film coated 173/017 Hovid Sdn Bhd, Malaysia 2751 Dapatab M 250 Tablets Methyldopa 250mg POM Tablet Film coated 173/018 Hovid Sdn Bhd, Malaysia 2752 Omezole 20 Capsules Omeprazole 20mg POM Capsule oral 173/019 Hovid Sdn Bhd, Malaysia 2753 Horamine Syrup Chlorpheniramine 4mg P Syrup 173/020 Hovid Sdn Bhd, Malaysia 2754 Hopranolol Tablets Propranolol 40mg POM Tablet Film coated 173/021 Hovid Sdn Bhd, Malaysia 2755 Norelut Tablets Norethisterone 5mg POM Tablet Uncoated 173/023 Hovid Sdn Bhd, Malaysia 2756 Ampicap 250 Capsules Ampicillin 250mg POM Capsule oral 173/026 Hovid Sdn Bhd, Malaysia 2757 Virest 200mg Tablets Acyclovir 200mg POM Tablet Film coated 173/027 Hovid Sdn Bhd, Malaysia 2758 Tinazole 2% Cream Miconazole 2%w/w POM Cream Topical 173/028 Hovid Sdn Bhd, Malaysia 2759 Celexin Capsules Cephalexin 250mg POM Capsule oral 173/029 Hovid Sdn Bhd, Malaysia 2760 Doxicap Capsules Doxycycline 100mg POM Capsule oral 173/030 Hovid Sdn Bhd, Malaysia 2761 Tetracap 250mg Capsules Tetracycline 250mg POM Capsule oral 173/031 Hovid Sdn Bhd, Malaysia 2762 Cortisone Cream Hydrocortisone 1%w/w POM Cream Topical 173/032 Hovid Sdn Bhd, Malaysia 2763 Virest Cream Acyclovir 5%w/w POM Cream Topical 173/033 Hovid Sdn Bhd, Malaysia Betasone Cream Betamethasone 0.1%w/w POM Cream Topical 173/034 Hovid Sdn Bhd, Malaysia 2764 2765 Ventamol 2mg Tablets Salbutamol 2mg POM Tablet Uncoated 173/035 Hovid Sdn Bhd, Malaysia 2766 Ventamol 4mg Tablets Salbutamol 4mg POM Tablet Uncoated 173/036 Hovid Sdn Bhd, Malaysia 2767 Prednisolone Tablets Prednisolone 5mg POM Tablet Uncoated 173/037 Hovid Sdn Bhd, Malaysia Hostan Paediatric Suspension Mefenamic Acid 125mg, P Suspension for 173/038 Hovid Sdn Bhd, Malaysia 2768 per 5ml Oral Use 2769 Neurovit Tablets B Complex P Tablet Uncoated 173/039 Hovid Sdn Bhd, Malaysia 2770 Colodium Capsules Loperamide 2mg POM Capsule oral 173/040 Hovid Sdn Bhd, Malaysia Hovid Betaton Capsules Beta Caraotene + P Capsule oral 173/041 Hovid Sdn Bhd, Malaysia 2771 Multivitamin 2772 Erotab Erythromycin Tablets Erythromycin 250mg POM Tablet Film coated 173/042 Hovid Sdn Bhd, Malaysia 2773 Cloxamp 250mg Capsules Cloxacillin 250mg POM Capsule oral 173/043 Hovid Sdn Bhd, Malaysia 2774 Ventamol Syrup Salbutamol 2mg, per 5ml POM Syrup 173/044 Hovid Sdn Bhd, Malaysia 2775 Diabetmin Tablets Metformin 500mg POM Tablet Film coated 173/045 Hovid Sdn Bhd, Malaysia Amoxigram Granules Amoxicillin 125mg, per POM Granules for 173/046 Hovid Sdn Bhd, Malaysia 2776 5ml Suspension

Page 143 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Colospan Tablets Hyoscine Butyl Bromide POM Tablet Film coated 173/048 Hovid Sdn Bhd, Malaysia 2777 10mg 2778 Clamide-5 Tablets Glibenclamide 5mg POM Tablet Uncoated 173/049 Hovid Sdn Bhd, Malaysia 2779 Praziquantel Tablets Praziquantel 600mg POM Tablet Uncoated 222/001 IDA Foundation, The Netherlands 2780 Aciclovir Eye Ointment Aciclovir 3% w/w POM Eye Ointment 222/001MT IDA Foundation, The Netherlands Ceftriaxone Injection Ceftriaxone 1g POM Powder for 222/002MT IDA Foundation, The Netherlands 2781 Injection Chloramphenicol Sodium Chloramphenicol 1g POM Powder for 222/003MT IDA Foundation, The Netherlands 2782 succinate Injection Injection 2783 Ciprofloxacin Tablets Ciprofloxacin 250mg POM Tablet Uncoated 222/004MT IDA Foundation, The Netherlands 2784 Erythromycin Stearate Tablets Erythromycin 250mg POM Tablet Uncoated 222/005MT IDA Foundation, The Netherlands Co-trimoxazole Tablets Sulfamethoxazole 400mg POM Tablet Uncoated 222/006MT IDA Foundation, The Netherlands + Trimethoprim 80mg 2785 Nystatin 100,000 IU Oral Nystatin 100,000 IU POM Suspension for 222/008MT IDA Foundation, The Netherlands 2786 Suspension Oral Use Cotrimoxazole Tablets Trimethoprim 80mg+ POM Tablet Uncoated 222/009MT IDA Foundation, The Netherlands Sulphamethoxazole 2787 400mg Co-trimoxazole Tablets Sulphamethoxazole POM Tablet Uncoated 222/010MT IDA Foundation, The Netherlands 800mg + Trimethoprim 2788 160mg Cotrimoxazole Tablets Sulphamethoxazole POM Tablet Uncoated 222/011MT IDA Foundation, The Netherlands 100mg + Trimethoprim 2789 20mg Artesunate + Amodiaquine Amodiaquine 50mg + POM Tablet Uncoated 222/013MT IDA Foundation, The Netherlands 2790 Tablets Artesunate 200mg Ceftriaxone Injection Ceftriaxone 250mg POM Powder for 222/014MT IDA Foundation, The Netherlands 2791 Injection 2792 Cefixime Tablets Cefixime 200mg POM Tablet Uncoated 222/015MT IDA Foundation, The Netherlands 2793 Fluconazole Capsules Fluconazole 200mg POM Capsule oral 222/016MT IDA Foundation, The Netherlands 2794 Fluconazole Capsules Fluconazole 50mg POM Capsule oral 222/017MT IDA Foundation, The Netherlands 2795 Fluconazole Capsules Fluconazole 150mg POM Capsule oral 222/018MT IDA Foundation, The Netherlands 2796 Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 222/019 IDA Foundation, The Netherlands 2797 Erythromycin Tablets Erythromycin 250mg POM Tablet Uncoated 222/020MT IDA Foundation, The Netherlands

Page 144 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Multivitamin Tablets Vitamin A2500IU + GS Tablet Film coated 222/021MT IDA Foundation, The Netherlands Vitamin B 37.5mg + Vitamin B1 1mg +Vitamin C 0.15mg +Vitamin B2 0.5mg + Vitamin 300IU 2798 Amoxiciliin BP 250mg Capsules Amoxicillin 250mg POM Capsule oral 222/022MT IDA Foundation, The Netherlands 2799 2800 Metronidazole 200mg Tablets Metronidazole 200mg POM Tablet Uncoated 222/023 IDA Foundation, The Netherlands 2801 Amoxicillin BP 250mg Tablets Amoxicillin 250mg POM Tablet Uncoated 222/024MT IDA Foundation, The Netherlands Gentamycin Injection Gentamycin 80mg, per POM Solution for 222/025MT IDA Foundation, The Netherlands 2802 2ml Injection Erythromycin Suspension Erythromycin 125mg, per POM Powder for Oral 222/026MT IDA Foundation, The Netherlands 2803 5ml Suspension Metronidazole 125mg/5ml Metronidazole 125mg POM Powder for Oral 222/027MT IDA Foundation, The Netherlands 2804 Powder for Oral Suspension Suspension 2805 Doxycycline Capsules Doxycycline 100mg POM Capsule oral 222/028MT IDA Foundation, The Netherlands Abhayrab Vaccine Inactivated Rabies POM Solution for 088/001 Indian Immunological limited 2806 Antigen 2.5IU, per 0.5ml Injection Abay tox IP Vaccine Tetanus Toxoid Vaccine Suspension for 088/002 Indian Immunological limited 2807 0.5ml Injection 2808 Metaplex Syrup B Complex P Syrup 152/001 Indoco Remedies Limited, India Flamar Cream Methyl Salicylate 8.0% P Cream Topical 152/002 Indoco Remedies Limited, India w/w + Mephenesin 5.0% w/w + Methyl Nictinate 1.0% w/w + Methanol 2809 2.05 w/w 2810 Indo 250 Tablets Erythromycin 250mg POM Tablet Film coated 152/003 Indoco Remedies Limited, India 2811 Concise 50 Tablets Fluconazole 50mg POM Tablet Uncoated 152/004 Indoco Remedies Limited, India 2812 Ciprind 250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 152/005 Indoco Remedies Limited, India 2813 Nimind Tablets Nimesulide 100mg POM Tablet Uncoated 152/006 Indoco Remedies Limited, India 2814 Dexoren Eye/Ear Drops Chlorampenicol 0.5%w/v POM Ear/Eye Drops 152/007 Indoco Remedies Limited, India 2815 Tamigen Eye/Ear Drops Gentamycin 0.3%w/v POM Ear/Eye Drops 152/008 Indoco Remedies Limited, India 2816 Atropen-P Eye Drops Atropine 1%w/v POM Eye Drops 152/009 Indoco Remedies Limited, India Cyclopam Tablets Paracetamol + P Tablet Uncoated 152/010 Indoco Remedies Limited, India 2817 Dicyclomine Metchek Tablets Metformin Hydrochloride POM Tablet Uncoated 152/011 Indoco Remedies Limited, India 2818 500mg 2819 Triz Tablets Cetirizine 10mg POM Tablet Uncoated 152/012 Indoco Remedies Limited, India

Page 145 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Febrex Plus Tablets Paracetamol 500mg + P Tablet Uncoated 152/013 Indoco Remedies Limited, India Phenylephrine Hydrochloride 10mg + 2820 Chlopheniramine 2mg Febrex Plus Syrup Paracetamol 125mg + P Syrup 152/014 Indoco Remedies Limited, India Sodium Citrate 60mg +Phenylephrine 2821 Hydrocloride 2.5mg Otorex Ear Drops Paradichlorobenzene P Solution for Topical 152/015 Indoco Remedies Limited, India 2.0%w/v + Benzocaine Use 2.7%w/v + Chlorobutanol 2822 5.0%w/v Cital Solution Disodium Hydrogen P Solution for Oral 152/016 Indoco Remedies Limited, India 2823 Citrate 1.37 mg Use DentoGel Choline Salicylate P Gel Topical 152/017 Indoco Remedies Limited, India 8.7%w/w + Lignocaine 2824 Hcl 2.0% w/w Rexidin - M Gel Metronidazole Benzoate P Gel Oral 152/018 Indoco Remedies Limited, India 10mg/g + Chlorhexidine Gluconate Solutio 2825 0.25%w/w Cloben G Cream Clotrimazole 1% w/w + POM Cream Topical 152/019 Indoco Remedies Limited, India Gentamycin 0.1%w/w + Beclomethasone Dipropionate 0.025% w/w 2826 2827 Clob Cream Clotrimazole 1.0%w/w POM Cream Topical 152/020 Indoco Remedies Limited, India 2828 Ibuflamar 200 Tablets Ibuprofen 200mg P Tablet Uncoated 152/021 Indoco Remedies Limited, India 2829 Megyl Tablets Metronidazole 200mg POM Tablet Uncoated 152/022 Indoco Remedies Limited, India Flamar MX Tablets Diclofenac potassium P Tablet Uncoated 152/023 Indoco Remedies Limited, India 50mg + Paracetamol 325mg + Chlorzoxazone 2830 250mg Cloben Skin Cream Clotrimazole 1% w/w + Cream Topical 152/024 Indoco Remedies Limited, India Beclomethasone Dipropionate 0.025% w/w 2831

Page 146 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Nosic Tablets Doxylamine Succinate 10 POM Tablets 152/025 Indoco Remedies Limited, India mg + Pyridoxine 2832 Hydrochloride 10 mg Viscid Gel Aluminium Hydroxide GS Oral suspension 152/026 Indoco Remedies Limited, India 400mg + Magnesium Hydroxide 100mg + 2833 Simethicone 25mg Lignox 2% Injection Lidocaine 20 mg , per ml POM Solution for 152/027 Indoco Remedies Limited, India 2834 Injection Karvol Plus Inhalant Capsules Camphor 25mg + GS Liquid capsule for 152/028 Indoco Remedies Limited, India Chlorothymol 5mg + Inhalation Eucalyptol 125mg + Menthol 55mg + 2835 Terpineol 120mg 2836 Clarie-250 Tablets Clarithromycin 250mg POM Tablet Uncoated 260/001 Ind-Swift Limited, India 2837 Netazox 500 Tablets Nitazoxanide 500mg POM Tablet Uncoated 260/002 Ind-Swift Limited, India Netazox Oral Suspension Nitazoxanide 100mg, per POM Suspension for 260/003 Ind-Swift Limited, India 2838 5ml Oral Use 2839 Candez 4 Tablets Candesartan 4mg POM Tablet Uncoated 260/004 Ind-Swift Limited, India 2840 Atstat 10 Tablets Atorvastatin 10mg POM Tablet Uncoated 260/005 Ind-Swift Limited, India 2841 Atstat 20 Tablets Atorvastatin 20mg POM Tablet Uncoated 260/006 Ind-Swift Limited, India Fexidine 120 Tablets Fexofenadine POM Tablet Uncoated 260/007 Ind-Swift Limited, India 2842 Hydrocloride 120mg Fexidine 180 Tablets Fexofenadine POM Tablet Uncoated 260/008 Ind-Swift Limited, India 2843 Hydrochloride 180mg 2844 Glitter 15 Tablets Pioglitazone 15mg POM Tablet Uncoated 260/009 Ind-Swift Limited, India 2845 Glitter 30 Tablets Pioglitazone 30mg POM Tablet Uncoated 260/010 Ind-Swift Limited, India Lamitar - AM Tablets Lumefantrine 120mg + POM Tablet Uncoated 260/011 Ind-Swift Limited, India 2846 Artemether 20mg Levoset Levocetrizine POM Tablet Film coated 376/001 Innovata Pharmaceuticals (Pty) Ltd 2847 Dihydrochloride 5mg Paratram Tramadol hydrochloride P Tablet Film coated 376/002 Innovata Pharmaceuticals (Pty) Ltd 37.5mg + Paracetamol 2848 325mg 2849 Citara 250 Tablets Levetiracetam 250mg POM Tablet Film coated 376/003 Innovata Pharmaceuticals (Pty) Ltd 2850 Citara 500 Tablets Levetiracetam 500mg POM Tablet Film coated 376/004 Innovata Pharmaceuticals (Pty) Ltd 2851 Citara 750 Tablets Levetiracetam 750mg POM Tablet Film coated 376/005 Innovata Pharmaceuticals (Pty) Ltd 2852 Citara 1000 Tablets Levetiracetam 1000mg POM Tablet Film coated 376/006 Innovata Pharmaceuticals (Pty) Ltd

Page 147 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Avalife Colon Care Capsules Lactobacillus acidophilus P Capsule oral 376/019L Innovata Pharmaceuticals (Pty) Ltd La14 + Lactobacillus casei Lc11+ Lactobacillus lactis Ll23, Bifidobacterium bifidium Bb01 + Fructooligosaccharide 2853 50mg) Avalife Femilora Capsules Lactobacillus acidophilus P Capsule oral 376/022L Innovata Pharmaceuticals (Pty) Ltd La14 + Lactobacillus plantarum LP115 + Lactobacillus rhamnosus Lr32 + Lactobacillus salivarisLs33+Fructooligo saccharide 30mg + organic cranberry fruit juice powder 500mg + D- 2854 Mannose 100mg Avalife Proreuteri-D Drops Lactobacillus reuteri LRE P Solution for Oral 376/021L Innovata Pharmaceuticals (Pty) Ltd 2mg + Ergocalceferol (Vit Use D3) 10mcg + Sunflower oil 0.364ml + MCT Oil 0.135ml + Silicon dioxide 0.0025mg/ 0.5ml 2855 Sweloze Herbal Cough Syrup Leaf of Vasa 800mg + P Syrup 376/020L Innovata Pharmaceuticals (Pty) Ltd Leaf of Tulsi 120mg + 2856 Plant of Kantakar Ducym 20 Capsules Duloxetine hydrochloride POM Capsule oral 376/019 Innovata Pharmaceuticals (Pty) Ltd 2857 20mg Ducym 30 capsules Duloxetine hydrochloride POM Capsule oral 376/020 Innovata Pharmaceuticals (Pty) Ltd 2858 30mg Ducym 60 Capsules Duloxetine hydrochloride POM Capsule oral 376/021 Innovata Pharmaceuticals (Pty) Ltd 2859 60mg 2860 Innrika 25 Capsules Pregabalin 25mg POM Capsule oral 376/032 Innovata Pharmaceuticals (Pty) Ltd 2861 Innrika 75 Capsules Pregabalin 75mg POM Capsule oral 376/033 Innovata Pharmaceuticals (Pty) Ltd 2862 Innrika 150 Capsules Pregabalin 150mg POM Capsule oral 376/034 Innovata Pharmaceuticals (Pty) Ltd Innofer 100 Injection Iron Sucrose 100mg POM Suspension for 376/025 Innovata Pharmaceuticals (Pty) Ltd 2863 Injection

Page 148 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Irocan 40 Injection Irinotecan hydrochloride POM Solution for 376/026 Innovata Pharmaceuticals (Pty) Ltd 2864 trihydrate 40mg infusion Irocan 100 Injection Irinotecan hydrochloride POM Solution for 376/027 Innovata Pharmaceuticals (Pty) Ltd 2865 trihydrate 100mg infusion Irocan 300 Injection Irinotecan hydrochloride POM Solution for 376/028 Innovata Pharmaceuticals (Pty) Ltd 2866 trihydrate 300mg infusion Irocan 500 injection Irinotecan hydrochloride POM Solution for 376/029 Innovata Pharmaceuticals (Pty) Ltd 2867 trihydrate 500mg infusion Valvasc 5/160 FC Tablets Amlodipine 5mg POM Tablet Film coated 376/023 Innovata Pharmaceuticals (Pty) Ltd 2868 +Valsartan 160mg Valvasc 10/160 Film Coated Amlodipine 10mg + POM Tablet Film coated 376/024 Innovata Pharmaceuticals (Pty) Ltd 2869 Tablets Valsartan 160mg 2870 Furocsem 250 Tablets Cefuroxime axetil 250mg POM Tablet Film coated 376/030 Innovata Pharmaceuticals (Pty) Ltd 2871 Furocsem 500 Tablets Cefuroxime axetil 500mg POM Tablet Film coated 376/031 Innovata Pharmaceuticals (Pty) Ltd Canol Infusion Topetecan hydrochloride POM Powder for 376/022 Innovata Pharmaceuticals (Pty) Ltd 2872 4mg Injection Dicloflame Tablets Diclofenac 50mg P Tablet Enteric 085/002 Intas International Pharmaceuticals Co. Ltd, 2873 Coated India Presilone Tablets Prednisolone 5mg POM Tablet Uncoated 085/003 Intas International Pharmaceuticals Co. Ltd, 2874 India Methyldopa Tablets Methyldopa 282 mg (as POM Tablet Uncoated 085/004 Intas International Pharmaceuticals Co. Ltd, 2875 Levo isomer) India Amoxycillin Tablets Amoxycillin 250mg POM Capsule oral 085/005 Intas International Pharmaceuticals Co. Ltd, 2876 India Intacillin Tablets Ampicillin 250 mg POM Tablet Uncoated 085/006 Intas International Pharmaceuticals Co. Ltd, 2877 India Binimycin Tablets Erythromycin Stearate POM Tablet Uncoated 085/007 Intas International Pharmaceuticals Co. Ltd, 2878 440mg India Asthamol Tablets Salbutamol Sulphate POM Tablet Uncoated 085/008 Intas International Pharmaceuticals Co. Ltd, 2879 4.820mg India Intrim 480 Tablets Sulphamethoxazole POM Tablet Uncoated 085/009 Intas International Pharmaceuticals Co. Ltd, 400mg+ Trimethoprim India 2880 80mg Piroflame Tablets Piroxicam 10mg POM Tablet Uncoated 085/010 Intas International Pharmaceuticals Co. Ltd, 2881 India Intafen Tablets Ibuprofen 200mg P Tablet Uncoated 085/011 Intas International Pharmaceuticals Co. Ltd, 2882 India Intalol 100mg Tablets Atenolol 100mg POM Tablet Uncoated 085/012 Intas International Pharmaceuticals Co. Ltd, 2883 India

Page 149 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Intalol 50 mg Tablets Atenolol 50mg POM Tablet Uncoated 085/015 Intas International Pharmaceuticals Co. Ltd, 2884 India Spasmine Injection Hyoscine Butyl Bromide POM Solution for 085/017 Intas International Pharmaceuticals Co. Ltd, 2885 20mg Injection India Ranloc Tablets Ranitidine 150mg POM Tablet Film coated 085/018 Intas International Pharmaceuticals Co. Ltd, 2886 India Carditas Retard Tablets Nifedipine 20mg POM Tablet Film coated 085/019 Intas International Pharmaceuticals Co. Ltd, 2887 India Monit-10 Tablets Isosorbide 10mg POM Tablet Uncoated 085/020 Intas International Pharmaceuticals Co. Ltd, 2888 India Monit-20 Tablets Isosorbide 20mg POM Tablet Uncoated 085/021 Intas International Pharmaceuticals Co. Ltd, 2889 India Astem-10 Tablets Astemizole 10mg POM Tablet Uncoated 085/023 Intas International Pharmaceuticals Co. Ltd, 2890 India Enapril - 10mg Tablets Enalapril 10mg POM Tablet Uncoated 085/024 Intas International Pharmaceuticals Co. Ltd, 2891 India Enapril 5mg Tablets Enalapril 5mg POM Tablet Uncoated 085/025 Intas International Pharmaceuticals Co. Ltd, 2892 India FCN Tablets Fluconazole 200mg POM Capsule oral 085/026 Intas International Pharmaceuticals Co. Ltd, 2893 India Kwinil-300 Tablets Quinine 300mg POM Tablet Film coated 085/027 Intas International Pharmaceuticals Co. Ltd, 2894 India Intagenta Injection Gentamycin 80mg, per POM Solution for 085/028 Intas International Pharmaceuticals Co. Ltd, 2895 2ml Injection India Dicloflame Injection Diclofenac 75mg, per 3ml POM Solution for 085/029 Intas International Pharmaceuticals Co. Ltd, 2896 Injection India Ciflox Tablets Ciprofloxacin 250mg POM Tablet Uncoated 085/030 Intas International Pharmaceuticals Co. Ltd, 2897 India Malostat Tablets Mefloquine 250mg POM Tablet Uncoated 085/031 Intas International Pharmaceuticals Co. Ltd, 2898 India Zen-200 Tablets Carbamazepine 200mg POM Tablet Uncoated 085/032 Intas International Pharmaceuticals Co. Ltd, 2899 India Cimecid Tablets Cimetidine 200mg POM Tablet Uncoated 085/033 Intas International Pharmaceuticals Co. Ltd, 2900 India Doxytas Capsules Doxycycline 100mg POM Capsule oral 085/035 Intas International Pharmaceuticals Co. Ltd, 2901 India Meflostats Tablets Mefloquine 250mg POM Tablet Uncoated 085/038 Intas International Pharmaceuticals Co. Ltd, 2902 India

Page 150 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Praziquantel Tablets Praziquantel 600mg POM Tablet Uncoated 085/039 Intas International Pharmaceuticals Co. Ltd, 2903 India Rifampicin + Isoniazid Tablets Rifampicin 150mg + POM Tablet Uncoated 085/040 Intas International Pharmaceuticals Co. Ltd, 2904 Isoniazid 100mg India Spasmintas-10 Tablets Hyoscine Butyl Bromide POM Tablet Enteric 085/041 Intas International Pharmaceuticals Co. Ltd, 2905 10mg Coated India Intavita Capsules Minerals + Mutivitamin P Tablet Uncoated 085/043 Intas International Pharmaceuticals Co. Ltd, 2906 India Aclotas SR Tablets Aceclofenac 200mg P Tablet Uncoated 085/044 Intas International Pharmaceuticals Co. Ltd, 2907 India Lipitas-20 Atorvastatin 20mg POM Tablet Uncoated 085/045 Intas International Pharmaceuticals Co. Ltd, 2908 India Valtas OD-500 Tablets Valproic acid 500mg POM Tablet Uncoated 085/046 Intas International Pharmaceuticals Co. Ltd, 2909 India Amtas 5 Tablets Amlodipine 5mg POM Tablet Uncoated 085/047 Intas International Pharmaceuticals Co. Ltd, 2910 India Amtas-10 Tablets Amlodipine 10mg POM Tablet Uncoated 085/048 Intas International Pharmaceuticals Co. Ltd, 2911 India Lan-30 Capsules Lansoprazole 30mg POM Capsule oral 085/049 Intas International Pharmaceuticals Co. Ltd, 2912 India Lovastin-10 Tablets Lovastatin 10mg POM Tablet Uncoated 085/050 Intas International Pharmaceuticals Co. Ltd, 2913 India Risdone 1mg Tablets Risperidone 1mg POM Tablet Uncoated 085/051 Intas International Pharmaceuticals Co. Ltd, 2914 India Risdone 2mg Tablets Risperidone 2mg POM Tablet Film coated 085/052 Intas International Pharmaceuticals Co. Ltd, 2915 India Doverin 80 Tablets Drotaverin Hydrochloride POM Tablet Uncoated 085/053 Intas International Pharmaceuticals Co. Ltd, 2916 80mg India Tortas 10 Tablets Torasemide 10mg POM Tablet Uncoated 085/054 Intas International Pharmaceuticals Co. Ltd, 2917 India Mims Co-trimoxazole Tablets Trimethoprim 80mg + POM Tablet Uncoated 155/001 International Drug Company Limited Sulfamethoxazole 400mg 2918 Mims Pain Rub Ointment Menthol + Camphor + GS Ointment topical 155/002 International Drug Company Limited Eucalyptus + Pine Oil + Nutmeg + Methyl 2919 Salicylate Mims AntAcid Suspension Aluminium Hydroxide + GS Suspension for 155/003 International Drug Company Limited 2920 Magnesium Trisilicate Oral Use

Page 151 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Mims Children Cough Syrup Guaiphenesin + P Syrup 155/004 International Drug Company Limited 2921 Paracetamol 2922 Mims metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 155/005 International Drug Company Limited Mims vitamin B complex Tablets B Complex P Tablet Uncoated 155/006 International Drug Company Limited 2923 Mims Co-trimoxazole Sulphamethoxazole 200 POM Suspension for 155/007 International Drug Company Limited Suspension + Trimethoprim 40mg, Oral Use 2924 per 5ml Mims No-Coff Syrup Guaiphenesin + Race P Syrup 155/008 International Drug Company Limited Menthol + Creosate wood 2925 oil + Pine Mims Fastamol Syrup Paracetamol 120mg, per GS Syrup 155/009 International Drug Company Limited 2926 5ml Mims Gripe Water Solution Dill oil + Sodium GS Solution for Oral 155/010 International Drug Company Limited Bicarbonate + Sodium Use 2927 Citrate 2928 Mims Pheniramine Tablets Chlorpheniramine 4mg P Tablet Uncoated 155/011 International Drug Company Limited Mims Salbutamol Syrup Salbutamol 2.5mg, per POM Syrup 155/012 International Drug Company Limited 2929 5ml 2930 Mims GV Paint Suspension Methylrosanilinium P Suspension 155/013 International Drug Company Limited Mims Whitefield Ointment Salicylic acid 6%w/w + P Ointment topical 155/014 International Drug Company Limited 2931 Benzoic Acid 3%w/w Mims Metronidazole Suspension Metronidazole 30mg, per POM Suspension for 155/016 International Drug Company Limited 2932 5ml Oral Use Dextrose 5% Intravenous Fluid Dextrose 5%w/v POM Solution for 155/017 International Drug Company Limited 2933 infusion Sodium Chloride Intravenous Sodium Chloride POM Solution for 155/018 International Drug Company Limited 2934 Fluid 0.9%w/v infusion Darrows Solution for Injection Sodium Chloride 2g + POM Solution for 155/019 International Drug Company Limited Sodium Lactate 2.95g + infusion Potassium Chloride 1.3g, 2935 per 500ml Ringer's Lactate Intravenous Sodium Chloride 6g + POM Solution for 155/020 International Drug Company Limited Fluid Sodium Lactate 3.1g + infusion Potassium Chloride 0.3g + Calcium Chloride 0.2g, 2936 per L Dextrose 10% Intravenous Dextrose 10%w/v POM Solution for 155/021 International Drug Company Limited 2937 Fluid Injection

Page 152 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Dextrose 2.5%+ Half Strength Dextrose 2.5% + Sodium POM Solution for 155/022 International Drug Company Limited Darrows I.V Infusion Chloride 2g + Sodium Injection Lactate 2.95g + Potassium Chloride 1.3g, 2938 per 1000ml Dextrose + Sodium Chloride Dextrose 5% w/v + POM Solution for 155/023 International Drug Company Limited Infusion Sodium Chloride infusion 2939 0.9%w/v Mims Idphen Syrup Ammonium Chloride P Solution for Oral 155/024 International Drug Company Limited 200mg + Menthol 2mg + Use 2940 Chlorpheniramine 2mg 2941 Mims Mutivitamins Syrup Multivitamins GS Syrup 155/025 International Drug Company Limited Mims Benzyl Benzoate Benzyl Benzoate 25 P Solution for Topical 155/026 International Drug Company Limited 2942 Application 25% w/w %w/w Use Mims Phenamine Syrup Chlorpheniramine 2mg, P Syrup 155/027 International Drug Company Limited 2943 per 5ml Fenelyn Expectorant Diphenhydramine P Solution for Oral 155/028 International Drug Company Limited Hydrochloride 12.5mg + Use Ammonium Chloride 125mg + Sodium Citrate 2944 50mg + Menthol 1mg Mims Promine Elixir Promethazine 5mg, per P Elixir 155/029 International Drug Company Limited 2945 5ml Mims Calamine Lotion Calamine 15% w/v + Zinc P Lotion for Topical 155/030 International Drug Company Limited Oxide 5% w/v + Liquified Use Phenol 0.4% w/v 2946 Mims Peppermint Coughs and Peppermint Oil 0.02mg + P Syrup 155/031 International Drug Company Limited 2947 Cold Syrup Menthol 3.5mg Mims Zinc &Castor Oil Ointment Arachis Oil 30.50%w/w + P Ointment topical 155/032 International Drug Company Limited Zinc Oxide 7.50% w/w+ 2948 Castor Oil 50% w/w

Page 153 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Mims Vapour Rub Ointment Menthol 3% w/w + GS Ointment topical 155/033 International Drug Company Limited Camphor 3% w/w + Eucalyptus oil 1.25% w/w + Pine oil 0.5% w/w + Thymol crystals 0.10% w/w + Nutmeg oil 0.55% w/w + Terpentine oil 5% 2949 w/w 2950 Mims Mobilub Capsules Glucosamine 500mg P Capsule oral 155/034 International Drug Company Limited 2951 Mims Rejuva Capsules Multivitamin P Capsule oral 155/037 International Drug Company Limited Mims Cod liver Oil Capsules Cod Liver Oil 300mg GS Capsule oral 155/035 International Drug Company Limited, 2952 Zambia Mims cod liver oil + vitamin E Cod Liver Oil 300mg + GS Capsule oral 155/036 International Drug Company Limited, 2953 Capsules Vitamin E 400mg Zambia Bupacin Injection 50mg/ml - Buparvaquone 50 mg, POM Solution for 382/001 Intracin Pharmaceuticals Pvt Ltd 2954 20ml per ml (VET) Injection Bupacin Injection 50mg/ml - Buparvaquone 50 mg, POM Solution for 382/002 Intracin Pharmaceuticals Pvt Ltd 2955 50ml per ml (VET) Injection Butafen-400 Tablets Ibuprofen 400mg P Tablet Enteric 114/001 IPCA Laboratories Ltd, India 2956 Coated 2957 Butafen-200 Tablets Ibuprofen 200mg P Tablet Uncoated 114/002 IPCA Laboratories Ltd, India 2958 Cimet-200 Tablets Cimetidine 200mg POM Tablet Uncoated 114/003 IPCA Laboratories Ltd, India 2959 Cimet-400 Tablets Cimetidine 400mg POM Tablet Uncoated 114/004 IPCA Laboratories Ltd, India 2960 Chloramphenicol Capsules Chloramphenicol 250mg POM Capsule oral 114/005 IPCA Laboratories Ltd, India 2961 Tetracycline 250mg Capsules. Tetracycline 250mg POM Capsule oral 114/006 IPCA Laboratories Ltd, India Giardyl Suspension Metronidazole 200mg, POM Suspension for 114/007 IPCA Laboratories Ltd, India 2962 per 5ml Oral Use Nebagin Injection Dipyron 500mg, per ml POM Solution for 114/008 IPCA Laboratories Ltd, India 2963 Injection 2964 Prednisolone Tablets Prednisolone 5mg POM Tablet Uncoated 114/009 IPCA Laboratories Ltd, India Metoclopromide Solution Metoclopramide 5mg, per POM Solution for Oral 114/010 IPCA Laboratories Ltd, India 2965 5ml Use Perinan Injection Metoclopramide 5mg, per POM Solution for 114/011 IPCA Laboratories Ltd, India 2966 ml Injection Nemocid Tablets Pyrantel Pamoate 125mg P Tablet Uncoated 114/012 IPCA Laboratories Ltd, India 2967 Pyrantel Pamoate Suspension Pyrantel Pamoate P Suspension for 114/013 IPCA Laboratories Ltd, India 2968 125mg, per 5ml Oral Use

Page 154 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Erythromycin Suspension Erythromycin 125mg, per POM Suspension for 114/014 IPCA Laboratories Ltd, India 2969 5ml Oral Use 2970 Pacimol 500mg Tablets Paracetamol 500mg P Tablet Uncoated 114/015 IPCA Laboratories Ltd, India Pacimol Syrup Paracetamol 125mg, per GS Syrup 114/016 IPCA Laboratories Ltd, India 2971 5ml 2972 Clarbact 250 Tablets Clarithromycin 250mg POM Tablet Uncoated 114/018 IPCA Laboratories Ltd, India 2973 Clarbact 500 Tablets Clarithromycin 500mg POM Tablet Uncoated 114/019 IPCA Laboratories Ltd, India 2974 Normax Tablets Norfloxacin 400mg POM Tablet Uncoated 114/020 IPCA Laboratories Ltd, India Stericef Injection Cefuroxime 1g POM Powder for 114/021 IPCA Laboratories Ltd, India 2975 Injection Larither 40 Injection Artemether 40mg, per ml POM Solution for 114/022 IPCA Laboratories Ltd, India 2976 Injection Cincoma Injection Quinine 300mg, per 1ml POM Solution for 114/023 IPCA Laboratories Ltd, India 2977 Injection Imox Trihydrate Capsules Amoxicillin Trihydrate POM Capsule oral 114/024 IPCA Laboratories Ltd, India 2978 250mg Imox Dry Syrup Amoxicillin Trihydrate POM Suspension for 114/025 IPCA Laboratories Ltd, India 2979 125mg, per 5ml Oral Use 2980 Ipcacillin Capsules Ampicillin 250mg POM Capsule oral 114/026 IPCA Laboratories Ltd, India 2981 Ipcavite-m Multivitamins GS Syrup 114/027 IPCA Laboratories Ltd, India Laridox Tablets Pyrimethamine 25mg + P Tablet Uncoated 114/028 IPCA Laboratories Ltd, India 2982 Sulphadoxine 500mg Larither-80 Injection Artemether 80mg POM Solution for 114/029 IPCA Laboratories Ltd, India 2983 Injection 2984 Procip-250 Capsules Ciprofloxacin 250mg POM Tablet Uncoated 114/030 IPCA Laboratories Ltd, India 2985 Tenolol Tablets Atenolol 100mg POM Tablet Uncoated 114/031 IPCA Laboratories Ltd, India 2986 Tenolol-50 Tablets Atenolol 50mg POM Tablet Uncoated 114/032 IPCA Laboratories Ltd, India 2987 Zerodol Tablets Aceclofenac 100mg P Tablet Uncoated 114/033 IPCA Laboratories Ltd, India Lumerax 20/120 Tablets Artemether 20mg + POM Tablet Uncoated 114/034 IPCA Laboratories Ltd, India 2988 Lumefantrine 120mg 2989 Pari -CR 12.5 Tablets Paroxetine 12.5mg POM Tablet Uncoated 114/035 IPCA Laboratories Ltd, India 2990 Pari-CR 25 Tablets Paroxetine 25mg POM Tablet Uncoated 114/036 IPCA Laboratories Ltd, India 2991 Lisoril-5 Tablets Lisinopril 5mg POM Tablet Uncoated 114/037 IPCA Laboratories Ltd, India 2992 Glyree-1 Tablets Glimepiride 1mg POM Tablet Uncoated 114/038 IPCA Laboratories Ltd, India 2993 Glyree-2 Tablets Glimepiride 2mg POM Tablet Uncoated 114/039 IPCA Laboratories Ltd, India 2994 Glimepiride 3mg Tablets Glimepiride 3mg POM Tablet Uncoated 114/040 IPCA Laboratories Ltd, India 2995 Glimepiride 4mg Tablets Glimepiride 4mg POM Tablet Uncoated 114/041 IPCA Laboratories Ltd, India 2996 Nilitis 750mg Tablets Nabumetone 750mg POM Tablet Uncoated 114/042 IPCA Laboratories Ltd, India 2997 Nilitis 500mg Tablets Nabumetone 500mg POM Tablet Uncoated 114/043 IPCA Laboratories Ltd, India 2998 Azifast-500 Tablets Azithromycin 500mg POM Tablet Uncoated 114/045 IPCA Laboratories Ltd, India

Page 155 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 2999 Revelol xl 25 Tablets Metoprolol 25mg POM Tablet Uncoated 114/046 IPCA Laboratories Ltd, India 3000 Revelol xl 50 Tablets Metoprolol 50mg POM Tablet Uncoated 114/047 IPCA Laboratories Ltd, India 3001 Emnorm 500 Tablets Metformin 500mg POM Tablet Uncoated 114/048 IPCA Laboratories Ltd, India 3002 Emnorm 850 Tablets Metformin 850mg POM Tablet Uncoated 114/049 IPCA Laboratories Ltd, India Lisoretic -10 Tablets Hydrochlorothiazide POM Tablet Uncoated 114/050 IPCA Laboratories Ltd, India 12.5mg + Lisinopril 10mg 3003 Lisoretic -20 Tablets Hydrochlorothiazide POM Tablet Uncoated 114/051 IPCA Laboratories Ltd, India 3004 12.5mg + Lisinopril20mg 3005 Piomed-15 Tablets Pioglitazone 15mg POM Tablet Uncoated 114/052 IPCA Laboratories Ltd, India 3006 Piomed-30 Tablets Pioglitazone 30mg POM Tablet Uncoated 114/053 IPCA Laboratories Ltd, India 3007 Presartan-25 Tablets Losartan 25mg POM Tablet Uncoated 114/054 IPCA Laboratories Ltd, India 3008 Presartan-50 Tablets Losartan 50mg POM Tablet Film coated 114/055 IPCA Laboratories Ltd, India 3009 Ramcor-1.25 Tablets Ramipril 1.25mg POM Tablet Uncoated 114/056 IPCA Laboratories Ltd, India 3010 Ramcor-2.5 Tablets Ramipril 2.5mg POM Tablet Uncoated 114/057 IPCA Laboratories Ltd, India 3011 Ramcor-5 Tablets Ramipril 5mg POM Tablet Uncoated 114/058 IPCA Laboratories Ltd, India 3012 Ramcor-10 Tablets Ramipril 10mg POM Tablet Uncoated 114/059 IPCA Laboratories Ltd, India Betamotil Injection Beta Arteether 150mg, POM Solution for 114/060 IPCA Laboratories Ltd, India 3013 per 2ml Injection Cinkona Suspension Quinine 150mg, per 5ml POM Suspension for 114/061 IPCA Laboratories Ltd, India 3014 Oral Use Arthemeter + Lumefanterine Artemether 20mg + POM Tablet Uncoated 114/062 IPCA Laboratories Ltd, India 3015 Tablets Lumefantrine 120mg Tenoric 50 Tablets Atenolol 50mg + POM Tablet Uncoated 114/063 IPCA Laboratories Ltd, India 3016 Chlortalidone 12.50mg Tenoric 100 Tablets Atenolol 100mg + POM Tablet Uncoated 114/064 IPCA Laboratories Ltd, India 3017 Chlortalidone 25mg 3018 Olex -7.5 Tablets Olanzepine 7.5mg POM Tablet Uncoated 114/065 IPCA Laboratories Ltd, India 3019 Zerodol-CR Tablets Aceclofenac 200mg POM Tablet Uncoated 114/066 IPCA Laboratories Ltd, India 3020 Glycinorm -80 Tablets Gliclazide 80mg POM Tablet Uncoated 114/067 IPCA Laboratories Ltd, India Presartan - H Tablets Lorsartan 50mg + POM Tablet Uncoated 114/068 IPCA Laboratories Ltd, India Hydrochlorothiazide 3021 12.5mg Cotrimoxazole BP Tablets Trimethoprim 80mg + POM Tablet Uncoated 114/069 IPCA Laboratories Ltd, India Sulfamethoxazole 3022 400mg Glyree - M 1 Tablets Glimepiride USP 1mg + POM Tablet Uncoated 114/071 IPCA Laboratories Ltd, India Metformin Hydrochloride 3023 USP 500mg

Page 156 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Glyree - M 2 Tablets Glimepiride USP 2mg + POM Tablet Uncoated 114/072 IPCA Laboratories Ltd, India Metformin Hydrochloride 3024 USP 500mg Rapiclav 1g Tablets Amoxicillin trihydrate 875 POM Tablet Uncoated 114/073 IPCA Laboratories Ltd, India mg + Clavulanate 3025 Potassium 125mg Nutrifiber Resistant Maltodextrin Powder for Oral 114/074 IPCA Laboratories Ltd, India 1.270g + Partially Suspension hydrolyzed Guar Gum 1.110g + Inulin 1.320g + 3026 Mannitol 0.800g Larinate Injection Artesunate BP 60 mg POM Solution for 114/075 IPCA Laboratories Ltd, India 3027 Injection iASAQ Tablets Artesunate 100mg + POM Tablet Uncoated 114/076 IPCA Laboratories Ltd, India 3028 Amodiaquine 270mg iSAQ 50/135 Tablets Artesunate 50mg + POM Tablet Uncoated 114/077 IPCA Laboratories Ltd, India 3029 Amodiaquine 135mg Pantonex -DR 20 Tablets Pantoprazole Sodium POM Tablet delayed 114/078 IPCA Laboratories Ltd, India 3030 Sesquihydrate BP 20mg Release Pantonex -DR 40 Tablets Pantoprazole Sodium POM Tablet delayed 114/079 IPCA Laboratories Ltd, India 3031 Sesquihydrate BP 40mg Release Zitram - SR 200 Tablets Tramadol Hydrochloride POM Tablet sustained 114/080 IPCA Laboratories Ltd, India 3032 Ph. Eur 200mg release Cotrimoxazole Oral Suspension Trimethoprim BP 40mg + POM Suspension for 114/081 IPCA Laboratories Ltd, India Sulfamethoxazole BP Oral Use 3033 200mg 3034 Multicharge Capsules (Men) Combination P Capsule oral 114/082L IPCA Laboratories Ltd, India Multicharge Capsules Women Minerals + Natural P Capsule oral 114/083L IPCA Laboratories Ltd, India Extracts + Methionine 22mg + Glutamic Acid 20 mg + Lysin 10mg + 3035 Cystein 2.5mg Multicharge Eye Capsules Eicosapantaenoic Acid P Capsule oral 114/084L IPCA Laboratories Ltd, India 325mg + Docosahexaenoic Acid 175mg + Lutein 5mg + 3036 Zeaxanthin 1mg 3037 Multicharge Daily Capsules Combination P Capsule oral 114/085L IPCA Laboratories Ltd, India

Page 157 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Multicharge Daily Heart Capsule combination of oils and P Capsule oral 114/087 Ipca Laboratories Ltd, India 3038 minerals Lumerax DT 20/120 Artemether 20mg + POM Tablet Film coated 114/086 Ipca Laboratories Ltd, India 3039 Lumefantrine 120mg Lumerax 80/480 tablets Arthemether 80mg + POM Tablet Uncoated 114/088 Ipca Laboratories Ltd, India 3040 Lumefantrine 480mg Beclasone CFC Free Metered Beclamethasone 50mcg POM Powder for 004/001 Ivax Pharma Ireland, Ireland 3041 Doses Inhaler Inhalation Salmol CFC Free Metered Dose Salbutamol 100mcg per POM Powder for 004/002 Ivax Pharma Ireland, Ireland 3042 Inhaler Metered Dose Inhalation Haycrom Aqueous Eye Drops Sodium Cromoglycate POM Eye Drops 004/003 Ivax Pharma Ireland, Ireland 3043 2% Warfarin Tablets Warfarin Sodium 100mcg POM Tablet Uncoated 004/004 Ivax Pharma Ireland, Ireland 3044 3045 Ivytimol Eye Drops Timolol 5mg, per ml POM Eye Drops 189/001 Ivee Aqua EPZ Limited, Kenya 3046 Ivygentacin Eye/Ear Drops Gentamycin 3mg, per ml POM Ear/Eye Drops 189/002 Ivee Aqua EPZ Limited, Kenya Ivyphenicol Eye Drops Chloramphenicol 5mg, POM Eye Drops 189/003 Ivee Aqua EPZ Limited, Kenya 3047 per ml Ivyzoxam Eye/Ear Drops Ciprofloxacin 3mg, per ml POM Ear/Eye Drops 189/004 Ivee Aqua EPZ Limited, Kenya 3048 3049 Ivynoraxine Eye/Ear Drops Norfloxacin 3mg, per ml POM Ear/Eye Drops 189/005 Ivee Aqua EPZ Limited, Kenya Ivydexone Eye Drops Dexamethasone 1mg, POM Eye Drops 189/006 Ivee Aqua EPZ Limited, Kenya 3050 per ml Ivysone Ophthalmic Solution Hydrocortisone 10mg, POM Eye Drops 189/007 Ivee Aqua EPZ Limited, Kenya 3051 per ml Ivysolone Opthlamic Prednisolone 10mg, per POM Eye Suspension 189/008 Ivee Aqua EPZ Limited, Kenya 3052 Suspension ml Ivydexnicol Eye Drops Dexamethasone 1mg+ POM Eye Drops 189/009 Ivee Aqua EPZ Limited, Kenya Chloramphenicol 10mg, 3053 per ml Ivydexgent Eye/Ear Drops Gentamycin 4mg + POM Ear/Eye Drops 189/010 Ivee Aqua EPZ Limited, Kenya Dexamethasone 3mg, 3054 per ml Ivydexneocin Eye/Ear Drops Dexamethasone 3.5mg POM Ear/Eye Drops 189/011 Ivee Aqua EPZ Limited, Kenya + Neomycin 1mg, per ml 3055 3056 Ivytimol Eye Drops Timolol 0.5mg, per ml POM Eye Drops 189/012 Ivee Aqua EPZ Limited, Kenya Ivysine Eye Drops Tetrahydrozoline 0.5mg, POM Eye Drops 189/013 Ivee Aqua EPZ Limited, Kenya 3057 per ml

Page 158 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Ivyzinc Eye Drops Zinc Sulphate 2.5mg, per POM Eye Drops 189/014 Ivee Aqua EPZ Limited, Kenya 3058 ml Ivyflur Eye Drops Flurbiprofen 0.3mg, per POM Eye Drops 189/015 Ivee Aqua EPZ Limited, Kenya 3059 ml Ivymoicell Eye Drops Hydroxypropylmethyl POM Eye Drops 189/016 Ivee Aqua EPZ Limited, Kenya 3060 Cellulose 7mg, per ml 3061 Ivyfrin Nasal Drops Ephedrine 10mg, per ml POM Nasal drops 189/017 Ivee Aqua EPZ Limited, Kenya 3062 Ivyfrin Nasal Drops Ephedrine 5mg, per ml POM Nasal drops 189/018 Ivee Aqua EPZ Limited, Kenya Ivynozvin A Nasal Drops Xylometazoline 1mg, per POM Nasal drops 189/019 Ivee Aqua EPZ Limited, Kenya 3063 ml Ivyfrin P Nasal Drops Xylometazoline 0.5mg, POM Nasal drops 189/020 Ivee Aqua EPZ Limited, Kenya 3064 per ml Ivyfchlornicol Ear Drops Drops Chloramphenicol 50mg, POM Ear Drops 189/021 Ivee Aqua EPZ Limited, Kenya 3065 per ml Ivybetasone Eye Drops Betamethasone 1mg, per POM Eye Drops 189/022 Ivee Aqua EPZ Limited, Kenya 3066 ml Ivybetaneocin Eye/Ear Drops Betamethasone 3.5mg + POM Ear/Eye Drops 189/023 Ivee Aqua EPZ Limited, Kenya 3067 Neomycin 1mg, per ml 3068 Ivyxolol Eye Drops Betaxolol 5mg, per ml POM Eye Drops 189/024 Ivee Aqua EPZ Limited, Kenya Water for Injection Sterile Water BP POM Solution for 189/025 Ivee Aqua EPZ Limited, Kenya 3069 Injection 3070 Ivycarp Eye Drops Pilocarpine 20mg, per ml POM Eye Drops 189/026 Ivee Aqua EPZ Limited, Kenya Ivycrom Eye Drops Sodium Cromoglycate POM Eye Drops 189/027 Ivee Aqua EPZ Limited, Kenya 3071 20mg, per ml Trimetabol Oral Suspension Cyproheptadine P Solution for Oral 324/001 J.Uriach Y Company, S.A Acefyllinate 0.035mg + DI- Use Carmitine Hydrochloride 3072 7.00mg Lusia - F Tablets Ethinyl Estradiol POM Tablet Film coated 211/001 Jai Pharmacueticals Ltd 0.0306mg + Norgesterel 3073 0.30mg 3074 Hyan Tablets Levonorgestrel 0.03mg POM Tablet Film coated 211/002 Jai Pharmacueticals Ltd 3075 Famyrel Tablets Norgestrel 0.075mg POM Tablet Film coated 211/003 Jai Pharmacueticals Ltd Oralcon Tablets Ethinyl Estradiol 0.03mg POM Tablet Film coated 211/004 Jai Pharmacueticals Ltd + Levonorgestrel 0.15mg 3076 3077 Pregnon Tablets Levonorgestrel 0.75mg POM Tablet Uncoated 211/005 Jai Pharmacueticals Ltd

Page 159 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Oralcon-F Tablets Ethinyl Estradiol 0.15mg POM Tablet Uncoated 211/006 Jai Pharmacueticals Ltd + Levonorgestrel 0.03mg 3078 Depo Progestin Injection Medroxyprogesterone POM Solution for 211/007 Jai Pharmacueticals Ltd 3079 150mg, per ml Injection Daisy Tablets Desogestrel 0.15mg + POM Tablet Uncoated 211/008 Jai Pharmacueticals Ltd 3080 EthnylEstradiol 0.03mg Cypress Tablets Cyproterone Acetate 2.04 POM Tablet Film coated 211/009 Jai Pharmacueticals Ltd + EthinylEstradiol 3081 0.03675 Zinnia Tablets EthinylEstradiol 30mcg + POM Tablet Film coated 211/010 Jai Pharmacueticals Ltd 3082 Levonogestrel 150mcg Zinnia P Tablets EthinylEstradiol 30mcg + POM Tablet Uncoated 211/011 Jai Pharmacueticals Ltd Levonogestrel 150 mcg 3083 Famy Depo Injectable Medroxyprogesterone POM Suspension for 211/012 Jai Pharmacueticals Ltd 3084 Suspension Acetate 150mg, per ml Injection Indoplant (Contraceptive Levonogestrel 75mg POM Implant 211/013 Jai Pharmacueticals Ltd 3085 Implant) Zinnia-F Tablets Levonorgestrel 150mcg + POM Tablet Film coated 211/014 Jai Pharmacueticals Ltd 3086 EthinylEstradiol 30mcg 3087 Revoke -72 Tablets Levonogestrel 0.75mg POM Tablet Film coated 211/015 Jai Pharmacueticals Ltd Caelyx Injection Doxorubicin POM Suspension for 071/006 Janssen Cilag Pharmaceuticals Limited Hydrochloride 2mg, per Injection 3088 ml Prezista 150 Tablets Darunavir Ethanolate POM Tablet Film coated 071/008 Janssen Cilag Pharmaceuticals Limited 3089 150mg Prezista 75 Tablets Darunavir Ethanolate POM Tablet Film coated 071/009 Janssen Cilag Pharmaceuticals Limited 3090 75mg Prezista 400 Tablets Darunavir Ethanolate 400 POM Tablets oral 071/010 Janssen Cilag Pharmaceuticals Limited 3091 mg Prezista 100mg, per ml Oral Darunavir Ethanolate POM Suspension for 071/011 Janssen Cilag Pharmaceuticals Limited 3092 Suspension 100mg, per ml Oral Use Daktacort Cream 20g Hydrocortisone 2% w/w + POM Cream Topical 009/007 Janssen-Cilag Pharmaceuticals Ltd 3093 Miconazole 1% w/w 3094 Gyno-Daktarin Vaginal Cream Miconazole 2% w/w POM Cream Vaginal 009/008 Janssen-Cilag Pharmaceuticals Ltd Daktacort Oral Gel Hydrocortisone 2% w/w + POM Gel Oral 009/010 Janssen-Cilag Pharmaceuticals Ltd 3095 Miconazole 1% w/w 3096 Daktarin Cream 20g Miconazole 2% w/w POM Cream Topical 009/011 Janssen-Cilag Pharmaceuticals Ltd

Page 160 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 3097 Stugeron Tablets 25mg Cinnarizine 25mg POM Tablet Uncoated 009/012 Janssen-Cilag Pharmaceuticals Ltd 3098 Immodium Capsules 2mg Loperamide 2mg POM Tablet Uncoated 009/013 Janssen-Cilag Pharmaceuticals Ltd 3099 Gyno-Daktarin Vaginal Ovules Miconazole 1200mg POM Ovule Vaginal 071/003 Janssen-Cilag Pharmaceuticals Ltd 3100 Daktarin Dusting Powder 2% Miconazole 2% w/w POM Powder Topical 081/001 Janssen-Cilag Pharmaceuticals Ltd 3101 Intelence Tablets Etravirine 25mg POM Tablet Uncoated 364/001 Janssen-Cilag Pharmaceuticals Ltd 3102 Zenglobin Syrup Vitamins + Zinc P Syrup 266/001 Jenburt Pharmaceuticals Limited 3103 Zeglobin Capsules Vitamins + Zinc P Capsule oral 266/002 Jenburt Pharmaceuticals Limited Cartisafe Forte MSM Tablets Glucosamine Sulphate P Tablets oral 266/003 Jenburt Pharmaceuticals Limited 750 mg + Elemental calcium 250 mg + Vitamin D3 125 IU + Methylsulfonylmethane 3104 200 mg Powergesic MR Tablets Chlorzoxazone 500 mg + P Tablets oral 266/004 Jenburt Pharmaceuticals Limited Paracetamol 325 mg + Diclofenac Sodium 50 3105 mg. Piritexyl – BR Tablets Terbutaline Sulphate 1.25 P Tablets oral 266/006 Jenburt Pharmaceuticals Limited mg + Ambroxol Hydrochloride 15 mg + Guaiphenesin 50 mg + 3106 Menthol 2.5 mg. Ojen-OZ Tablets Ofloxacin 200mg + POM Tablet Uncoated 266/007 Jenburt Pharmaceuticals Limited 3107 Ornidazole 500mg Luma Tablets Artemether 20mg + POM Tablet Uncoated 266/008 Jenburt Pharmaceuticals Limited 3108 Lumefantrine 120mg Powergesic Plus Gel Diclofenac 1%w/w + GS Gel Topical 266/009 Jenburt Pharmaceuticals Limited Methyl Salicylate 5%w/w + Menthol 1.0%w/w 3109 Nervijen -P Capsules Pregabalin 75mg + POM Capsule oral 266/010 Jenburt Pharmaceuticals Limited Methylcobalamin 750mcg + Vitamin B6 1.50mg + Benfothiam 3110 0.75mg Trega Cream Econazole 10mg + POM Cream Topical 266/011 Jenburt Pharmaceuticals Limited Triamcinolone Acetonide 3111 1mg + Gentamicin 1mg

Page 161 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Spymal Tablets Pyrimethamine 25mg + P Tablet Uncoated 022/001 JMB Pharmaceuticals Ltd, India 3112 Suphadoxine 500mg 3113 Besix Tablets Pyridoxine 50mg POM Tablet Uncoated 022/002 JMB Pharmaceuticals Ltd, India 3114 Nystem Tablets Nystatin 100,000 IU POM Tablet Uncoated 022/003 JMB Pharmaceuticals Ltd, India 3115 Multi mix Tablets Vitamin A 2500 IU POM Tablet Uncoated 022/004 JMB Pharmaceuticals Ltd, India 3116 Metroz - 200 Tablets Metronidazole 200mg POM Tablet Uncoated 022/005 JMB Pharmaceuticals Ltd, India 3117 Loperid Capsules Loperamide 2mg POM Capsule oral 022/006 JMB Pharmaceuticals Ltd, India Kotrim Tablets Sulfamethoxazole 400mg POM Tablet Uncoated 022/007 JMB Pharmaceuticals Ltd, India + Trimethoprim 80mg 3118 3119 Frude Tablets Frusemide 40mg POM Tablet Uncoated 022/008 JMB Pharmaceuticals Ltd, India 3120 Flucoz-200 Tablets Fluconazole 200mg POM Tablet Uncoated 022/009 JMB Pharmaceuticals Ltd, India 3121 Fego Tablets Paracetamol 500mg GS Tablet Uncoated 022/010 JMB Pharmaceuticals Ltd, India 3122 DS - 100 Tablets Diclofenac 100mg P Tablet Uncoated 022/011 JMB Pharmaceuticals Ltd, India 3123 Beco Tablets B Complex P Tablet Uncoated 022/012 JMB Pharmaceuticals Ltd, India 3124 Pentra-50 Tablets Sildenafil 50mg POM Tablet Uncoated 022/013 JMB Pharmaceuticals Ltd, India 3125 Vitacy Tablets Ascorbic Acid 100mg GS Tablet Uncoated 022/014 JMB Pharmaceuticals Ltd, India C.M.T Tablets Aluminium Hydrochloride GS Tablet Uncoated 022/015 JMB Pharmaceuticals Ltd, India 120mg + Magnesium 3126 Trisilicate 250mg 3127 Ciprroz 500 Ciprofloxacin 500mg POM Tablet Uncoated 022/016 JMB Pharmaceuticals Ltd, India 3128 Indomin-25 Tablets Indomethacin 25mg P Tablet Uncoated 022/017 JMB Pharmaceuticals Ltd, India Brumol Capsules Paracetamol 325mg + P Capsule oral 022/018 JMB Pharmaceuticals Ltd, India Ibuprofen 200mg + Caffeine anhydrous 30mg 3129 3130 Erymin 250 Tablets Erythromycin 250mg POM Tablet Uncoated 022/019 JMB Pharmaceuticals Ltd, India Duomal Tablets Artemether 20mg + POM Tablet Uncoated 022/020 JMB Pharmaceuticals Ltd, India 3131 Lumefantrine 120mg Flugripp Tablets Paracetamol 500mg + GS Tablet Uncoated 022/021 JMB Pharmaceuticals Ltd, India Caffeine 30mg + Chlorpheniramine 2mg + 3132 Phenylephrine 5mg 3133 Vermox Tablets Mebendazole 100mg P Tablets 009/003 Johnson & Johnson (Pty) Limited Combantrin Tablets Pyrantel Pamoate 125mg P Tablet Uncoated 048/001 Johnson & Johnson (Pty) Limited 3134 Visine Original Eye Drops Tetrahydrozoline P Eye Drops 050/001 Johnson & Johnson (Pty) Limited Hydrochloride 0.05% w/v 3135

Page 162 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Benylin for Colds Tablets Pseudoephedrine 30mg P Tablet Film coated 062/060 Johnson & Johnson (Pty) Limited 3136 + Ibuprofen 200mg Oraldine Mouth Wash Hexetidine 0.1g, per GS Solution for Oral 082/006 Johnson & Johnson (Pty) Limited 3137 100ml Use Chaberlain's Cough Remedy Guaiphenesin 50 mg, per P Syrup 082/007 Johnson & Johnson (Pty) Limited 3138 Regular Syrup 5 ml Chaberlain's Cough Remedy Guainphenesin 50 mg, P Syrup 082/008 Johnson & Johnson (Pty) Limited 3139 PepperMint Syrup per 5 ml + Peppermint Anusol Suppositories Bismuth Subgallate P Suppository 082/026 Johnson & Johnson (Pty) Limited 22.5mg + Bismuth Oxide 8.75mg + Zinc Oxide 3140 107.5mg Cool Mint Listerine Mouth Wash Alcohol 95% 4,58 ml + GS Solution for Oral 082/031 Johnson & Johnson (Pty) Limited 3141 Thymol 12,78 ml Use Anusol Ointment Bismuth P Ointment topical 082/032 Johnson & Johnson (Pty) Limited Subgallate22.5mg + Bismuth Oxide 8.75mg + 3142 Zinc Oxide 107.5mg Listerine Antiseptic MouthWash Thymol 12,781 mg + GS Solution for Oral 082/034 Johnson & Johnson (Pty) Limited Alcohol 95% 5 + Use 3143 Peppermint, per 20ml Benylin Wet Cough methol Guaifenesin 100mg, per P Syrup 082/039 Johnson & Johnson (Pty) Limited 3144 Syrup 5ml Benylin DMD Decongestant Dextromethorphan P Syrup 082/046 Johnson & Johnson (Pty) Limited Syrup HydroBromide 15 mg + Pseudoephedrine Hydrochloride 30 mg/5ml 3145 Benylin Dry Cough Syrup Dextromethorphan 15mg, P Syrup 082/047 Johnson & Johnson (Pty) Limited 3146 per 5ml Benylin 4 Flu Syrup Diphenhydramine P Syrup 082/048 Johnson & Johnson (Pty) Limited Hydrochloride 25mg+ Paracetamol 1000mg + Pseudoephedrine 3147 Hydrochloride 45mg

Page 163 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Benylin with Codeine Syrup Diphenhydramine P Syrup 082/049 Johnson & Johnson (Pty) Limited Hydrochloride 14mg + Codeine Phosphate 5.7mg + Levomenthol 3148 1.1mg, per 5 ml. Benylin Original Cough Syrup Diphenyhydramine P Syrup 082/050 Johnson & Johnson (Pty) Limited Hydrochloride 12.5mg + Ammoniun Chloride 3149 125mg Benylin Chest Cough Syrup Guaifenesin 100mg + P Syrup 082/051 Johnson & Johnson (Pty) Limited 3150 Levomenthol 1.1 mg Benylin Paediatric Diphenhydramine 7mg, P Syrup 082/052 Johnson & Johnson (Pty) Limited 3151 per 5ml Tartar control Listerine Alcohol 95% 4,54 ml GS Solution for Oral 082/053 Johnson & Johnson (Pty) Limited Antiseptic MouthWash +Thymol 12,78 mg + Zinc Use Chloride 18,0 mg, per 3152 20ml Fresburst Listerine MouthWash Alcohol 95% 4,540 ml + GS Solution for Oral 082/054 Johnson & Johnson (Pty) Limited Thymol 12,780 mg + Use Menthol + Eucalyptus, 3153 per 20ml Benylin Children Wet Cough Guaifenesin 200 mg, per P Syrup 082/055 Johnson & Johnson (Pty) Limited 3154 5ml Benylin Adult Wet Cough Syrup Guaiphenesin 200mg + P Syrup 082/056 Johnson & Johnson (Pty) Limited Sodium Benzoate 200mg 3155 Sinutab Sinus Allergy Paracetamol 500mg + P Tablet Uncoated 082/057 Johnson & Johnson (Pty) Limited Congestion and Pain Phenylephrine 2mg + Chlorpheniramine + 3156 Psuedoephedrine 30mg Sinutab Nasal Drop Spray Xylometazoline 1mg + POM Nasal drops 082/058 Johnson & Johnson (Pty) Limited Benzalkonium chloride 3157 0.02% Teeth and Gum Listerine Mouth Thymol 12,780mg + P Solution for Oral 082/059 Johnson & Johnson (Pty) Limited Wash Alcohol 4,540ml + Use Sodium Flouride 4,420mg 3158 Benylin Daytime Flu Tablets Pseudoephedrine 30mg P Tablet 082/060 Johnson & Johnson (Pty) Limited 3159 + Ibuprofen 200mg

Page 164 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Woods PepperMint Cough Combination GSL Syrup 153/001 Kalbe International Ltd, South Africa 3160 Syrup for Children Woods PepperMint Cough Combination GSL Syrup 153/002 Kalbe International Ltd, South Africa 3161 Syrup 3162 Karbazole Tablets Carbimazole 5mg POM Tablet Uncoated 098/001 Kamal International Ltd, India 3163 Kamlodipine Tablets Amlodipine 5mg POM Tablet Uncoated 098/002 Kamal International Ltd, India For-flu Tablets Paracetamol + P Tablet Uncoated 098/004 Kamal International Ltd, India Chlopheniramine + 3164 Caffeine Kamcold Tablets Paracetamol + P Tablet Uncoated 098/005 Kamal International Ltd, India Phenylephrine + Chlorpheniramine + 3165 Caffeine 3166 Power-apetite Tablets Cyproheptadine 4mg P Tablet Uncoated 098/006 Kamal International Ltd, India 3167 Kaonil Tablets Glibenclamide 5mg POM Tablet Uncoated 098/007 Kamal International Ltd, India Mixiderm Cream Miconazole + Neomycin POM Cream Topical 098/008 Kamal International Ltd, India 3168 + Beclomethasone 3169 Spironolactone 50mg Tablets Spironolactone 50mg POM Tablet Uncoated 098/009 Kamal International Ltd, India 3170 Kafen 100 Tablets Diclofenac 100mg P Tablet Uncoated 098/010 Kamal International Ltd, India 3171 Griseofulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 098/011 Kamal International Ltd, India 3172 Kamtrax Tablets Levamisole 40mg P Tablet Uncoated 098/012 Kamal International Ltd, India Sure Cream Iodochlorhydroxyqunolon POM Cream Topical 098/013 Kamal International Ltd, India e + Gentamycin + Bethamethasone + 3173 Tolnafate 3174 Klopera Tablets Loperamide 2mg POM Tablet Uncoated 098/014 Kamal International Ltd, India 3175 Kamtopril Tablets Captopril 25mg POM Tablet Uncoated 098/015 Kamal International Ltd, India 3176 Kaydigo Tablets Digoxin 0.25mg POM Tablet Uncoated 098/016 Kamal International Ltd, India 3177 Klax Tablets Bisacodyl 5mg POM Tablet Uncoated 098/017 Kamal International Ltd, India Obrocid Suspension Pyrantel Pamoate P Suspension for 098/018 Kamal International Ltd, India 3178 250mg, per 5ml Oral Use Ferrous Sulphate & Folic Acid Ferrous Sulphate 200mg P Tablet Uncoated 098/019 Kamal International Ltd, India 3179 Tablets + Folic Acid 0.25mg 3180 Knor Tablets Norethistrerone 5mg POM Tablet Uncoated 098/020 Kamal International Ltd, India 3181 Kamipramine Tablets Imipramine 25mg POM Tablet Uncoated 098/021 Kamal International Ltd, India 3182 Kantibac Tablets Nitrofurantoin 100mg POM Tablet Uncoated 098/023 Kamal International Ltd, India 3183 Kamvit-6 Tablets Pyridoxine 50mg POM Tablet Uncoated 098/024 Kamal International Ltd, India 3184 Kasipro 25mg Tablets Spironolactone 25mg POM Tablet Uncoated 098/025 Kamal International Ltd, India 3185 Kamfru Tablets Frusemide 40mg POM Tablet Uncoated 098/026 Kamal International Ltd, India

Page 165 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Oral Rehydration Salts Sodium Chloride 3.5g + POM Powder for Oral 098/027 Kamal International Ltd, India Sodium Citrate 1.5g + Solution Potassium Chloride 3186 2.9g+ Glucose 20g 3187 Kamvir Tablets Aciclovir 200mg POM Tablet Uncoated 098/028 Kamal International Ltd, India 3188 Kampred Tablets Prednisolone 5mg POM Tablet Uncoated 098/029 Kamal International Ltd, India 3189 Kamcard Tablets Propranolol 40mg POM Tablet Uncoated 098/030 Kamal International Ltd, India 3190 Karbapin Tablets Carbamazepine 200mg POM Tablet Uncoated 098/031 Kamal International Ltd, India 3191 7 Hours 50mg Tablets Sildenafil 50mg POM Tablet Uncoated 098/032 Kamal International Ltd, India 3192 7 Hours 50mg Oral Gel Sildenafil 50mg POM Gel Oral 098/033 Kamal International Ltd, India 3193 Boro Pearl Cream Herbal Extracts P Cream Topical 219/001 Kamdhenu Agro-Chem Industrires, India 3194 Foot heal Cream Herbal Extracts P Cream Topical 219/002HM Kamdhenu Agro-Chem Industrires, India 3195 Pain off Cream Herbal Extracts P Cream Topical 219/003 Kamdhenu Agro-Chem Industrires, India 3196 Granny's formula Gel Herbal Extracts P Gel Topical 219/004HM Kamdhenu Agro-Chem Industrires, India Benzyl Penicillin Injection 1MU Benzyl Penicillin 1 MU POM Powder for 255/001 Karnataka Antibiotics &Pharmaceuticals 3197 Injection Ltd, India Benzyl Penicillin Injection 5MU Benzyl Penicillin 5 MU POM Powder for 255/002 Karnataka Antibiotics &Pharmaceuticals 3198 Injection Ltd, India Ampicillin & Cloxacillin Injection Cloxacillin 250mg + POM Powder for 255/003 Karnataka Antibiotics &Pharmaceuticals 3199 Ampicillin 250mg Injection Ltd, India Cloxacillin Injection Cloxacillin 500mg POM Powder for 255/004 Karnataka Antibiotics &Pharmaceuticals 3200 Injection Ltd, India Ampicillin 500 Injection Ampicillin 500mg POM Powder for 255/005 Karnataka Antibiotics &Pharmaceuticals 3201 Injection Ltd, India Cefotaxime 1g Injection Cefotaxime 1 gram POM Powder for 255/006 Karnataka Antibiotics &Pharmaceuticals 3202 Injection Ltd, India Cefotaxime 500mg Injection Cefotaxime 500mg POM Powder for 255/007 Karnataka Antibiotics &Pharmaceuticals 3203 Injection Ltd, India Cefotaxime 250mg Injection Cefotaxime 250mg, per POM Powder for 255/008 Karnataka Antibiotics &Pharmaceuticals 3204 5ml Injection Ltd, India Procaine Penicillin Injection Procaine Benzyl Penicillin POM Powder for 255/009 Karnataka Antibiotics &Pharmaceuticals 3205 3 MU Injection Ltd, India Benzathine Penicillin Injection Benzathine Penicillin 5 POM Powder for 255/010 Karnataka Antibiotics &Pharmaceuticals 3206 5MU MU Injection Ltd, India Gentamycin Sulphate Injection Gentamycin 40mg, per ml POM Solution for 255/011 Karnataka Antibiotics &Pharmaceuticals 3207 Injection Ltd, India Ampicillin 1000 Injection Ampicillin 1000mg POM Powder for 255/012 Karnataka Antibiotics &Pharmaceuticals 3208 Injection Ltd, India 3209 Propranolol Tablets Propranolol 40mg POM Tablet Uncoated 007/001 Kausikh Therapeutics (P) Ltd, India

Page 166 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 3210 Chlorpheniramine Tablets Chlorpheniramine 4mg P Tablet Uncoated 007/002 Kausikh Therapeutics (P) Ltd, India 3211 Cimetidine Tablets Cimetidine 200mg POM Tablet Uncoated 007/003 Kausikh Therapeutics (P) Ltd, India 3212 Folic Acid Tablets Folic Acid 5mg P Tablet Uncoated 007/004 Kausikh Therapeutics (P) Ltd, India 3213 Tetracycline Capsules Tetracycline 250mg POM Capsule oral 007/005 Kausikh Therapeutics (P) Ltd, India 3214 Furosemide Tablets Furosemide 40mg POM Tablet Uncoated 007/006 Kausikh Therapeutics (P) Ltd, India 3215 Methyldopa Tablets Methyldopa 250mg POM Tablet Film coated 007/007 Kausikh Therapeutics (P) Ltd, India 3216 Nifedipine Tablets Nifedipine 20mg POM Tablet Uncoated 007/008 Kausikh Therapeutics (P) Ltd, India Ferrous Sulphate + Folic Acid Ferrous Sulphate + Folic P Tablets oral 007/009 Kausikh Therapeutics (P) Ltd, India 3217 Tablets Acid 3218 Aminophylline Tablets Aminophylline 100mg POM Tablet Uncoated 007/010 Kausikh Therapeutics (P) Ltd, India 3219 Ketoconazole Tablets Ketoconazole 200mg POM Tablet Uncoated 007/011 Kausikh Therapeutics (P) Ltd, India Penicillin V Tablets Phenoxymethyl Penicillin POM Tablet Uncoated 007/012 Kausikh Therapeutics (P) Ltd, India 3220 V 250mg 3221 Cloxacillin Capsules Cloxacillin 250mg POM Capsule oral 007/013 Kausikh Therapeutics (P) Ltd, India 3222 Ampicillin Capsules Ampicillin 250mg POM Capsule oral 007/014 Kausikh Therapeutics (P) Ltd, India 3223 Pyridoxine 50mg Tablets Pyridoxine 50mg P Tablet Uncoated 007/015 Kausikh Therapeutics (P) Ltd, India 3224 Omeprazole Capsules Omeprazole 20mg POM Capsule oral 007/016 Kausikh Therapeutics (P) Ltd, India Ampicillin and Cloxacillin Cloxacillin 250mg + POM Capsule oral 007/017 Kausikh Therapeutics (P) Ltd, India 3225 Capsules Ampicillin 250mg 3226 Hypocare-5 Tablets Amlodipine 5mg POM Tablet Uncoated 007/018 Kausikh Therapeutics (P) Ltd, India 3227 Ayocare Tablets Amlodipine 10mg POM Tablet Uncoated 007/019 Kausikh Therapeutics (P) Ltd, India 3228 Luxopril-20 Tablets Enalapril 20mg POM Tablet Uncoated 007/020 Kausikh Therapeutics (P) Ltd, India 3229 Luxcee 500 Tablets Ascorbic Acid 500mg GS Tablet Uncoated 007/021 Kausikh Therapeutics (P) Ltd, India 3230 Albendazole Tablets Albendazole 400mg POM Tablet Uncoated 007/022 Kausikh Therapeutics (P) Ltd, India 3231 Capril Tablets Captopril 25mg POM Tablet Uncoated 007/023 Kausikh Therapeutics (P) Ltd, India 3232 Domidome Tablets Domperidone 10mg POM Tablet Uncoated 007/024 Kausikh Therapeutics (P) Ltd, India 3233 Erythromycin Tablets Erythromycin 250mg POM Tablet Uncoated 007/025 Kausikh Therapeutics (P) Ltd, India 3234 Paracetamol Tablets Paracetamol 500mg GS Tablet Uncoated 007/026 Kausikh Therapeutics (P) Ltd, India 3235 Acyclvir Tablets Acyclovir 200mg POM Tablet Uncoated 007/027 Kausikh Therapeutics (P) Ltd, India 3236 Acyclovir Tablets Aciclovir 400mg POM Tablet Uncoated 007/028 Kausikh Therapeutics (P) Ltd, India 3237 Carbamazepine Tablets Carbamazepine 200mg POM Tablet Uncoated 007/029 Kausikh Therapeutics (P) Ltd, India Emthex 50 Injection Methotrexate 25mg, per POM Powder for 267/001 Khandelwal Laboratories Pvt.Ltd, India 3238 ml Injection Oncomide 500 Injection Cyclophosphamide POM Powder for 267/002 Khandelwal Laboratories Pvt.Ltd, India 3239 500mg Injection Platinex 50 Injection Cisplatin 1mg, per ml POM Powder for 267/003 Khandelwal Laboratories Pvt.Ltd, India 3240 Injection Womastin Injection Carboplatin 150mg, per POM Powder for 267/004 Khandelwal Laboratories Pvt.Ltd, India 3241 15ml Injection

Page 167 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Urafil 50 Injection Fluorouracil 500mg, per POM Powder for 267/005 Khandelwal Laboratories Pvt.Ltd, India 3242 10ml Injection 3243 Mamofen 10 Tablets Tamoxifen 10mg POM Tablet Uncoated 267/006 Khandelwal Laboratories Pvt.Ltd, India 3244 Mamofen 20 Tablets Tamoxifen 20mg POM Tablet Uncoated 267/007 Khandelwal Laboratories Pvt.Ltd, India 3245 Zophost Tablets Alendronate 10mg POM Tablet Uncoated 267/008 Khandelwal Laboratories Pvt.Ltd, India Anafortan Tablets Paracetamol + Camylofin P Tablet Film coated 267/009 Khandelwal Laboratories Pvt.Ltd, India 3246 3247 Converten 5 Tablets Enalapril 5mg POM Tablet Uncoated 267/010 Khandelwal Laboratories Pvt.Ltd, India 3248 Allerfast 120 Tablets Fexofenadine 120mg POM Tablet Film coated 267/011 Khandelwal Laboratories Pvt.Ltd, India 3249 Prenoxid 100 Tablets Prednisolone 100mg POM Tablet Film coated 267/012 Khandelwal Laboratories Pvt.Ltd, India ROIVT Multivitamin Ascorbic Acid 67.787mg GS Tablet Effervescent 392/001 Kilitch Drugs ( India) Limited Effervescent Tablets + Vitamin E 33mg + Nicotinamide 19mg + Calcium D 7mg + 3250 Pantothen 2.533mg ROIVT Vitamin C 1000mg Ascorbic Acid BP GS Tablet Effervescent 392/002 Kilitch Drugs ( India) Limited 3251 Effervescent Tablets 1000mg ROIVT Ginseng Plus Taurine 250mg + GS Tablet Effervescent 392/003 Kilitch Drugs ( India) Limited Effervescent Tablets Guarana extract 30mg + Ginseng root extract 3252 15mg + Caffeine 15mg Ceftriazone Sodium USP POM 392/004 Powder for ONECEF SB 1.5gm Injection 1gm + Sulbactam Kilitch Drugs ( India) Limited Injection 3253 Sodium 500mg POM Solution for 392/005 9-Vit Infusion Multivitamin infusion Kilitch Drugs ( India) Limited 3254 Infusion POM 421/001 Metronidazole 200mg Tablets Metronidazole 200mg Tablet Uncoated Kingphar Company Zambia Limited, Zambia 3255 GS 421/002 Sodium Chloride BP 2.6g + Potassium Chloride BP Oral Rehydration Salts, 21g, 1.5g + Trisodium Citrate Powder for solution Kingphar Company Zambia Limited, Zambia Powder Dihydrate BP 2.9g + Glucose Anhydrate BP 13.5g 3256 3257 Difisal SR Tablets Diclofenac 100mg P Tablet Film coated 250/001 Kopran Limited, India Ciproquin Tablets Ciprofloxacin USP POM Tablet Uncoated 250/002 Kopran Limited, India 3258 500mg 3259 Amyn Capsules Amoxicillin 250mg POM Capsule oral 250/003 Kopran Limited, India

Page 168 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Ampicloxa Dry Suspension Cloxacillin 250mg + POM Suspension for 250/004 Kopran Limited, India 3260 Ampicillin 250mg Oral Use 3261 Paralget Tablets Paracetamol 500mg GS Tablet Uncoated 250/005 Kopran Limited, India Eryko Oral Suspension Erythromycin 125mg, per POM Suspension for 250/006 Kopran Limited, India 3262 5ml Oral Use 3263 Az-1 Capsules Azithromycin 250mg POM Capsule oral 250/007 Kopran Limited, India 3264 Lokit Capsules Omeprazole 20mg POM Capsule oral 250/008 Kopran Limited, India 3265 Difisal Tablets Diclofenac 50mg P Tablet Uncoated 250/009 Kopran Limited, India 3266 Ciproquin 250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 250/010 Kopran Limited, India 3267 Bren-200 Tablets Ibuprofen 200mg P Tablet Film coated 250/011 Kopran Limited, India 3268 Kometro 200 Tablets Metronidazole 200mg POM Tablet Uncoated 250/012 Kopran Limited, India 3269 Rintid 150 Tablets Ranitidine 150mg POM Tablet Uncoated 250/013 Kopran Limited, India 3270 Quinolox 400 Tablets Norfloxacin 400mg POM Tablet Uncoated 250/014 Kopran Limited, India Trim 480 Tablets Trimethoprim 80mg + POM Tablet Uncoated 250/015 Kopran Limited, India Sulphamethoxozole 3271 400mg Ampic Dry Syrup Ampicillin 125mg, per POM Syrup 250/016 Kopran Limited, India 3272 5ml 3273 Ampik Capsules Ampicillin 250mg POM Capsule oral 250/017 Kopran Limited, India 3274 Bren-400 Tablets Ibuprofen 400mg P Tablet Uncoated 250/018 Kopran Limited, India Trim Suspension Sulphamethoxazole POM Suspension for 250/019 Kopran Limited, India 200mg + Trimethoprim Oral Use 3275 40mg, per 5ml 3276 Eryko 250 Tablets Erythromycin 250mg POM Tablet Film coated 250/020 Kopran Limited, India Amyn Syrup Amoxicillin 125mg, per POM Granules for Oral 250/021 Kopran Limited, India 3277 5ml Solution 3278 Nubend 400 Tablets Albendazole 400mg POM Tablet Uncoated 250/023 Kopran Limited, India 3279 Klodip-5 Tablets Amlodipine 5mg POM Tablet Uncoated 250/024 Kopran Limited, India 3280 Zimat Tablets Cetirizine 10mg POM Tablet Uncoated 250/025 Kopran Limited, India 3281 Felexin 500 Capsules Cephalexin 500mg POM Capsule oral 250/026 Kopran Limited, India Cloxin Oral Solution Cloxacillin Sodium eq. to POM Granules for Oral 250/027 Kopran Limited, India 3282 125mg, per 5ml Solution Pulmin Inhaler Salbutamol BP 100mcg POM Powder for 250/028 Kopran Limited, India 3283 Inhalation AZ-1 500 Tablets Azithromycin Dihydrate POM Tablet Film coated 250/029 Kopran Limited, India 3284 500mg Mepran - 500 IV Injection Meropenem Trihydrate POM Powder for 250/030 Kopran Limited, India 3285 500mg Injection

Page 169 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Mepran - 1000 IV Injection Meropenem Trihydrate POM Powder for 250/031 Kopran Limited, India 3286 1000mg Injection Appeton A to Z Kids' Vitamin C Vitamin C 0.28g GS Capsule oral 450/001L Kotra Pharma (M) Sdn. Bhd. Malaysia 3287 Pastilles Artemeter Injection Artemether 80mg, per ml POM Solution for 135/001 Kunming Pharmaceutical Corp. (KPC), 3288 Injection China Artemether 40mg Tablets Artemether 40mg POM Tablet Uncoated 135/002 Kunming Pharmaceutical Corp. (KPC), 3289 China Artemether 50mg Tablets Artemether 50mg POM Tablet Uncoated 135/003 Kunming Pharmaceutical Corp. (KPC), 3290 China Gentamedine Injection Gentamycin 80,000iu, per POM Solution for 135/004 Kunming Pharmaceutical Corp. (KPC), 3291 2ml Injection China Vitamedine Injection Vitamin K POM Solution for 135/005 Kunming Pharmaceutical Corp. (KPC), 3292 Injection China Arco Tablets Artemisinine 250mg + POM Tablet Film coated 135/006 Kunming Pharmaceutical Corp. (KPC), 3293 Naphthoquine 100mg China Skineal Cream 15g (Ketoconazole 10mg + POM Cream Topical 135/007 Kunming Pharmaceutical Corp. (KPC), Clobetasol Propionate China 0.25mg + Neomycin 5000 3294 iu), per 1g Rapid Relief Hot Gel Menthol 5.91% + P Gel Topical 207/001 L`amar Natural Products Pvt Ltd,India Eucalyptus 1.97% + Methyl Salicylate 12.8% 3295 + Terpentine oil 1.47% 3296 Rapid relief cold Gel 30g Menthol 2% P Gel Topical 207/002 L`amar Natural Products Pvt Ltd,India Glutahenz Powder L-Glutamine 10g w/w P Powder for Oral 444/004L La Renon Healthcare Pvt. Ltd. 3297 Solution Enzispor Capsules Probiotic blend of P Capsule oral 444/005L La Renon Healthcare Pvt. Ltd. Bacillus clausii spores 2 3298 Billion CFU/ Capsule Kchek Oral Powder Calcium polystyrene P Powder for feed 444/006L La Renon Healthcare Pvt. Ltd. 3299 sulfonate BP 25g Sobisis 500mg Tablets Sodium Bicarbonate USP P Tablet Uncoated 444/002L La Renon Healthcare Pvt. Ltd. 3300 500mg Sobisis Forte Tablets Sodium Bicarbonate P Tablet Film coated 444/003L La Renon Healthcare Pvt. Ltd. 3301 Tablets USP 1000 mg

Page 170 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Cudo Forte Capsules Probiotic blend of P Capsule oral 444/001L La Renon Healthcare Pvt. Ltd. Streptococcus thermophilies+Lactobacil us 90 Billion CFU/ 3302 Capsule 3303 Levigress 250 Tablets Levetiracetam 250mg POM Tablet Uncoated 444/007 La Renon Healthcare Pvt. Ltd. 3304 Levigress 500 Tablets Levetiracetam 500mg POM Tablet Uncoated 444/008 La Renon Healthcare Pvt. Ltd. Anaesthetic F.D Injection Lignocaine 2 % + POM Solution for 026/001 Laboratories ZEYCO S.A 3305 Epinephrine 1:100,000 Injection 3306 Burnazine Cream 15g Silver Sulphadiazine 1% POM Cream Topical 309/001 Laboratory & Allied Limited, India 3307 Hycorum Cream 15g Hydrocortisone 1%w/w POM Cream Topical 309/002 Laboratory & Allied Limited, India Neogracin Dusting Powder 10g Neomycin Sulphate 5mg P Powder for Topical 309/003 Laboratory & Allied Limited, India + Bacitracin2.5mg + use 3308 Gramicidin D 0.5mg Gono Injection Specitinomycin POM Powder for 309/004 Laboratory & Allied Limited, India 3309 Hydrochloride 2.0g Injection Homagon Capsules Chlorpheniramine GS Tablet Uncoated 309/005 Laboratory & Allied Limited, India maleate 4mg + Paracetamol 350mg + Caffeine anhydrous 30mg + 3310 Pseudoephedrine 3mg Lastmol Salbutamol Sulphate P Syrup 309/006 Laboratory & Allied Limited, India 3311 2mg, per 5ml Kemoxyl 250 Capsules Amoxicillin Trihydrate POM Capsule oral 309/007 Laboratory & Allied Limited, India 3312 250mg 3313 Phenobarbiton 30 Tablets Phenobarbitone 30mg POM Capsule oral 309/008 Laboratory & Allied Limited, India 3314 Labesten Vaginal Tablets Nystatin 100,000 IU POM Tablet Uncoated 309/009 Laboratory & Allied Limited, India Lecotrim 480 Tablets Trimethoprim 80mg + POM Tablet Uncoated 309/010 Laboratory & Allied Limited, India Sulphamethoxazole 3315 400mg Axylin Capsules Ampicillin 250mg + POM Capsule oral 309/011 Laboratory & Allied Limited, India 3316 Cloxacillin 250mg Ferrolic LF Tablets Ferrous sulfate + Folic P Tablet Film coated 309/014 Laboratory & Allied Limited, India 3317 Acid Labesten Cream Chlotrimazole USP P Cream Topical 309/016 Laboratory & Allied Limited, India 3318 1%w/w Rheumac Gel Diclofenac Diethylamine P Gel Topical 309/015 Laboratory & Allied Limited, India 3319 1% w/v

Page 171 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 3320 Hydopa Tablets Methydopa 250mg POM Tablet Film coated 309/012 Laboratory & Allied Limited, India Labstatin Suspension Nystatin 100,000 IU POM Suspension for 309/017 Laboratory & Allied Limited, India 3321 Oral Use Laepen V Tablets Phenoxymethylpenicillin POM Tablet Uncoated 309/018 Laboratory & Allied Limited, India 3322 250mg 3323 Kloxy 250 Caspsules Cloxacillin 250mg POM Capsule oral 309/013 Laboratory & Allied Limited, India 3324 Coloncare Capsules Probiotics + Prebiotics P Capsule oral 424/009L Lactonova Nutripharm Private Limited Dermikelp shampoo Ecklonia maxima 31.5 GS Shampoo 301/001L Lamicare SA (PTY) Limited 3325 mg, per g Dermikelp topical Cream Ecklonia maxima 375 GS Cream Topical 301/002L Lamicare SA (PTY) Limited 3326 mg, per g Moxileb Dry Syrup Amoxycillin 125mg, per POM Granules for Oral 149/001 Leben Laboratories (Pvt) Limited, India 3327 5ml Use 3328 Cipium Tablets Chlorpheniramine 4mg P Tablet Uncoated 149/002 Leben Laboratories (Pvt) Limited, India 3329 Regurg 10mg Tablets Metoclopramide 10mg POM Tablet Uncoated 149/003 Leben Laboratories (Pvt) Limited, India 3330 Moxileb 250mg Capsules Amoxycillin 250mg POM Capsule oral 149/004 Leben Laboratories (Pvt) Limited, India 3331 Nalidixic Acid Tablets Nalidixic Acid 500mg POM Tablet Uncoated 149/005 Leben Laboratories (Pvt) Limited, India 3332 Trifluoperazine Tablets Trifluoperazine 5mg POM Tablet Film coated 149/006 Leben Laboratories (Pvt) Limited, India 3333 Amphen Capsules Chloramphenicol 250mg POM Capsule Oral 149/007 Leben Laboratories (Pvt) Limited, India 3334 Alclox Capsules Cloxacillin 250mg POM Capsule oral 149/008 Leben Laboratories (Pvt) Limited, India 3335 Metroleb - 200 Tablets Metronidazole 200mg POM Tablets Oral 149/009 Leben Laboratories (Pvt) Limited, India 3336 Griseben 125mg Tablets Griseofulvin 125mg POM Tablet Uncoated 149/010 Leben Laboratories (Pvt) Limited, India 3337 Propranolol 40mg Tablets Propranolol 40mg POM Tablet Uncoated 149/011 Leben Laboratories (Pvt) Limited, India 3338 Ateleb 100mg Tablets Atenolol 100mg POM Tablet Uncoated 149/012 Leben Laboratories (Pvt) Limited, India 3339 Ateleb 50mg Tablets Atenolol 50mg POM Tablet Uncoated 149/013 Leben Laboratories (Pvt) Limited, India 3340 Silveleb 1% Cream Silver Suphadiazine 1% P Cream Topical 149/014 Leben Laboratories (Pvt) Limited, India Scabcur lotion Lindane 1% P Lotion for Topical 149/015 Leben Laboratories (Pvt) Limited, India 3341 Use 3342 Benzyl Benzoate application Benzyl benzoate P Emulsion 149/016 Leben Laboratories (Pvt) Limited, India 3343 Tetret-250mg Capsules Tetracycline 250mg POM Capsule oral 149/017 Leben Laboratories (Pvt) Limited, India 3344 Indul 25mg Capsules Indomethacin 25mg P Capsule oral 149/018 Leben Laboratories (Pvt) Limited, India 3345 Ciproleb 500 Tablets Ciprofloxacin 500mg POM Tablet Film coated 149/019 Leben Laboratories (Pvt) Limited, India 3346 Ibut 200mg Tablets Ibuprofen 200mg P Tablet Film coated 149/020 Leben Laboratories (Pvt) Limited, India 3347 Promethazine 25mg Tablets Promethazine 25mg P Tablet Uncoated 149/021 Leben Laboratories (Pvt) Limited, India Zylo-P Topical Solution Povidone iodine 10%w/w P Solution for Topical 149/022 Leben Laboratories (Pvt) Limited, India 3348 Use 3349 Foliben 5mg Tablets Folic Acid 5mg POM Tablet Uncoated 149/023 Leben Laboratories (Pvt) Limited, India QSM Suspension Quinine 150mg POM Suspension for 149/024 Leben Laboratories (Pvt) Limited, India 3350 Oral Use 3351 Kelvin 500mg Tablets Paracetamol 500mg GS Tablet Uncoated 149/025 Leben Laboratories (Pvt) Limited, India

Page 172 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 3352 Adiflam Tablets Diclofenac 50mg POM Tablets Oral 149/026 Leben Laboratories (Pvt) Limited, India L-Trim Tablets Sulfamethoxazole 400mg POM Tablets Oral 149/027 Leben Laboratories (Pvt) Limited, India + Trimethoprim 80mg 3353 3354 Lebasma Syrup Salbutamol 2mg, per 5ml POM Syrup 149/028 Leben Laboratories (Pvt) Limited, India 3355 Lebasma-4 Tablets Salbutamol 4mg POM Tablet Uncoated 149/029 Leben Laboratories (Pvt) Limited, India Promethazine Syrup Promethazine 5mg, per P Syrup 149/030 Leben Laboratories (Pvt) Limited, India 3356 5ml Beclomin Ointment Beclomethasone POM Ointment topical 149/031 Leben Laboratories (Pvt) Limited, India Dipropionate 0.025% + Miconazole Nitrate BP 3357 2% + Neomycin BP 0.55 L-Trim Suspension Sulfamethoxazole 200mg POM Suspension for 149/032 Leben Laboratories (Pvt) Limited, India + Trimethoprim 40mg Oral Use 3358 3359 Chlorpromazine Tablets Chlorpromazine 100mg POM Tablet Film coated 149/033 Leben Laboratories (Pvt) Limited, India 3360 Doxyleb Capsule Doxycycline 100mg POM Capsule oral 149/034 Leben Laboratories (Pvt) Limited, India 3361 Lampy-250 Capsules Ampicillin 250mg POM Capsule oral 149/035 Leben Laboratories (Pvt) Limited, India 3362 Adiflam Gel Diclofenac 1 % w/w P Gel Topical 149/036 Leben Laboratories (Pvt) Limited, India Cipium Syrup Chlorpheniramine 2mg, P Syrup 149/037 Leben Laboratories (Pvt) Limited, India 3363 per ml Cebay-Trx-1000 Injection Ceftriaxone 1000mg POM Powder for 149/038 Leben Laboratories (Pvt) Limited, India 3364 Injection Cefaxil-1000 Injection Cefotaxime 1000mg POM Powder for 149/039 Leben Laboratories (Pvt) Limited, India 3365 Injection 3366 Prohibin Capsules Omeprazole 20mg POM Capsule oral 149/040 Leben Laboratories (Pvt) Limited, India Kelvin Syrup Paracetamol 120mg, per GS Syrup 149/041 Leben Laboratories (Pvt) Limited, India 3367 5ml Antagit-DS Gel Aluminium hydroxide P Gel Oral 149/042 Leben Laboratories (Pvt) Limited, India 400mg + Magnesium Hydroxide 400mg + 3368 Simethicone 50mg/5ml Alclox Suspension Cloxacillin 125mg, per POM Powder for Oral 149/043 Leben Laboratories (Pvt) Limited, India 3369 5ml Suspension Adiflam Injection Diclofenac 50mg, per 3ml POM Solution for 149/044 Leben Laboratories (Pvt) Limited, India 3370 Injection 3371 Cortileb Cream Hydrocortisone 1%w/w POM Cream Topical 149/045 Leben Laboratories (Pvt) Limited, India

Page 173 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Elcuf Syrup Chlorpheramine 2.5mg + P Syrup 149/046 Leben Laboratories (Pvt) Limited, India Ammonium Chloride 125mg + Sodium Citrate 3372 55mg, per 5ml Enderm G.M Cream Clobetasol 0.05% + POM Cream Topical 149/047 Leben Laboratories (Pvt) Limited, India Miconazole 2% + 3373 Gentamicin 0.1% Nystaleb Suspension Nystatin 100,000 iu, per POM Suspension for 149/048 Leben Laboratories (Pvt) Limited, India 3374 5ml Oral Use Libitus Plus Syrup Guanefenesin 50mg + POM Syrup 149/049 Leben Laboratories (Pvt) Limited, India Bromhexine 4mg + Terbutaline Sulphate 3375 1.25mg Pyraleb Suspension Pyrantel Pamoate P Suspension for 149/050 Leben Laboratories (Pvt) Limited, India 3376 125mg, per 5ml Oral Use 3377 Zylo-P Ointment Povidone Iodine 5% P Ointment topical 149/051 Leben Laboratories (Pvt) Limited, India Pyraleb Tablets Pyrantel Pamoate 125mg P Tablet Uncoated 149/052 Leben Laboratories (Pvt) Limited, India 3378 3379 Cexil 125 Syrup Cefadroxil 125mg/5ml POM Syrup 149/054 Leben Laboratories (Pvt) Limited, India 3380 Hykophos Syrup Multivitamins GS Syrup 149/055 Leben Laboratories (Pvt) Limited, India 3381 Cexil 500mg Tablets Cefadroxil 500mg POM Tablet Uncoated 149/056 Leben Laboratories (Pvt) Limited, India 3382 Chlorpromazine 25mg Tablets Chlorpromazine 25mg POM Tablet Film coated 149/057 Leben Laboratories (Pvt) Limited, India 3383 Haloperidol Tablets Haloperidol 1.5mg POM Tablet Uncoated 149/058 Leben Laboratories (Pvt) Limited, India Chelferron Liquid Haematinic preparation P Solution for Oral 149/059 Leben Laboratories (Pvt) Limited, India 3384 Use 3385 Greseben 500 Tablets Griseofulvin 500mg POM Tablets oral 149/060 Leben Laboratories (Pvt) Limited, India 3386 Q.S.M Tablets Quinine 300mg POM Tablet Uncoated 149/061 Leben Laboratories (Pvt) Limited, India Cebay - Trx 250 Injection Ceftriaxone 250mg POM Powder for 149/062 Leben Laboratories (Pvt) Limited, India 3387 Injection 3388 Lebasma 2 Tablets Salbutamol 2mg POM Tablet Uncoated 149/063 Leben Laboratories (Pvt) Limited, India Cebay 100 Dry Powder Cefixime 100mg, per 5ml POM Powder for Oral 149/064 Leben Laboratories (Pvt) Limited, India 3389 Suspension 3390 Praziquantel Tablets Praziquantel 600mg POM Tablet Uncoated 149/065 Leben Laboratories (Pvt) Limited, India 3391 Amileb-25 Tablets Amitriptyline 25mg POM Tablet Uncoated 149/066 Leben Laboratories (Pvt) Limited, India 3392 Betaleb Ointment Betamethasone 0.10% POM Ointment topical 149/067 Leben Laboratories (Pvt) Limited, India Kelvin-P Syrup Paracetamol 125mg + P Syrup 149/068 Leben Laboratories (Pvt) Limited, India Promethazine 6.25mg, 3393 per 5ml

Page 174 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Adiflam Compound Tablets Paracetamol 500mg + P Tablet Uncoated 149/069 Leben Laboratories (Pvt) Limited, India 3394 Diclofenac 50mg Adiflam Plus Tablets Paracetamol 500mg + P Tablet Uncoated 149/070 Leben Laboratories (Pvt) Limited, India 3395 Ibuprofen 400mg 3396 Ciproleb 250 Tablets Ciprofloxacin 250mg POM Tablet Film coated 149/071 Leben Laboratories (Pvt) Limited, India Lamizol O Suspension Ofloxacin 50mg + POM Suspension for 149/073 Leben Laboratories (Pvt) Limited, India Ornidazole 125mg, per Oral Use 3397 5ml Lamizol O Tablets Ofloxacin 200mg + POM Tablet Uncoated 149/074 Leben Laboratories (Pvt) Limited, India 3398 Ornidazole 500mg Ferrous Sulphate Tablets Ferrous Sulphate 200mg P Tablet Enteric 149/075 Leben Laboratories (Pvt) Limited, India 3399 Coated 3400 Multivitamins Tablets Multivitamins GS Tablet Film coated 149/076 Leben Laboratories (Pvt) Limited, India Sinurhon Tablets Paracetamol 500mg + P Tablet Uncoated 149/077 Leben Laboratories (Pvt) Limited, India Phenylephrine 5mg + Chlorpheniramine 2mg + 3401 Caffeine 30mg Adiflam -SR Tablets Diclofenac Sodium P Tablet Uncoated 149/078 Leben Laboratories (Pvt) Limited, India 3402 100mg Fricold Suspension (Paracetamol BP 250mg GS Suspension for 149/079 Leben Laboratories (Pvt) Limited, India + Chlorpheniramine Oral Use Maleate BP 2.0mg + Phenylephrin 5.0mg), per 5ml 3403 Kaldol Suspension Paracetamol 120mg, per GS Suspension for 149/080 Leben Laboratories (Pvt) Limited, India 3404 5ml Oral Use Moxileb CV 228.5 Dry Syrup (Amoxicillin 200mg + POM Syrup 149/081 Leben Laboratories (Pvt) Limited, India Clavulanic Acid 28.5mg), 3405 per 5ml Libitus Cough Syrup (Dextromethorphan POM Syrup 149/082 Leben Laboratories (Pvt) Limited, India HydroBromide BP 10.0mg + Phenylephrine Hydrochloride 5.0mg + Chlorpheniramine 3406 Maleate 2.0mg), per 5ml Rihaee Tablets Aceclofenac BP 100mg + P Tablet Film coated 149/083 Leben Laboratories (Pvt) Limited, India Paracetamol BP 500mg 3407

Page 175 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Colicspam Oral Drops (Dicyclomine POM Solution for Oral 149/084 Leben Laboratories (Pvt) Limited, India Hydrochloride 10mg + Use Simethicone 40mg), per 3408 5ml Colicspam Oral Suspension (Dicyclomine POM Suspension for 149/085 Leben Laboratories (Pvt) Limited, India Hydrochloride 10mg + Oral Use Simethicone 40mg), per 3409 5ml Adiflam Plus Suspension Ibuprofen BP 100mg + P Suspension for 149/086 Leben Laboratories (Pvt) Limited, India 3410 Paracetamol BP 125mg Oral Use Libitus LS Syrup Levosalbutamol Sulphate POM Syrup 149/087 Leben Laboratories (Pvt) Limited, India 1 mg + Ambroxol Hydrochloride BP 30mg + Guafenisin BP 50mg 3411 3412 Alwo 400 Tablets Albendazole 400mg POM Tablet Chewable 149/088 Leben Laboratories (Pvt) Limited, India Azileb 200 Suspension Azithromycin 200mg POM Suspension for 149/089 Leben Laboratories (Pvt) Limited, India 3413 Oral Use 3414 Azileb 500 Tablets Azithromycin 500mg POM Tablets Oral 149/090 Leben Laboratories (Pvt) Limited, India Betaleb Cream Betamethasone Valerate POM Cream Topical 149/091 Leben Laboratories (Pvt) Limited, India 3415 0.1%w/w Enderm Cream Clobetasol Propionate POM Cream Topical 149/092 Leben Laboratories (Pvt) Limited, India 3416 USP 0.05%w/w Sinurho Suspension Chlorpheniramine 1mg + POM Suspension for 228/069 Leben Laboratories (Pvt) Limited, India Phenylephrine 5mg + Oral Use 3417 Paracetamol 125mg Beclomin Lotion Beclomethasone POM Lotion for Topical 228/070 Leben Laboratories (Pvt) Limited, India Dipropionate BP 0.025% Use + Miconazole Nitrate BP 3418 2% HCT Tablets Hydrochlorothiazide POM Tablet Uncoated 228/071 Leben Laboratories (Pvt) Limited, India 3419 25mg IbuPlus Tablets Ibuprofen 400mg + P Tablet Uncoated 228/072 Leben Laboratories (Pvt) Limited, India 3420 Paracetamol 325mg Cypine Tablets Cyproheptadine POM Tablet Enteric 228/073 Leben Laboratories (Pvt) Limited, India 3421 Hydrochloride BP 4mg Coated 3422 Lib-Mox 250 Capsules Amoxicillin 250mg POM Capsule oral 284/001 Liberal Pharmaceuticals Limited, India Lib-Mox Suspension Amoxicillin 125mg, per POM Suspension for 284/002 Liberal Pharmaceuticals Limited, India 3423 5ml Oral Use

Page 176 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 3424 Lib-Dox-100 Capsules Doxycycline 100mg POM Capsule oral 284/003 Liberal Pharmaceuticals Limited, India 3425 Lib-Tetra Capsules Tetracycline 250mg POM Capsule oral 284/004 Liberal Pharmaceuticals Limited, India 3426 Lib-Indo-25 Capsules Indomethacin 25mg P Capsule oral 284/005 Liberal Pharmaceuticals Limited, India GS 409/001L Pudina (Mentha viridis) 5.75mg + Karpura D'Tuss Ginger Lozenges Lozenges Lifeon Labs Pvt Ltd (Cinnamomum camphora Nees ) 0.18mg (Multiple) 3427 GS 409/002L Pudina (Mentha viridis) D'Tuss Honey & Lemon 5.75mg + Karpura Lozenges Lifeon Labs Pvt Ltd Lozenges (Cinnamomum camphora Nees ) 0.18mg (Multiple) 3428 Pudina (mentha viridis) GS 409/003L 7mg + Taila Parni D’Tuss Menthol Lozenges Lozenges Lifeon Labs Pvt Ltd (Eucalyptus globus) 3429 3.3mg GS 409/004L Pudina (Mentha viridis) 5.75mg + Karpura D'Tuss Orange Lozenges Lozenges Lifeon Labs Pvt Ltd (Cinnamomum camphora Nees ) 0.18mg (Multiple) 3430 Chloramphenicol Injection Chloramphehicol 1g POM Powder for 228/001 Lincoln Pharmaceuticals Ltd, India 3431 Injection Lincosone Cream 15g Neomycin 0.5% + POM Cream Topical 228/002 Lincoln Pharmaceuticals Ltd, India Clotrimazole 1% + 3432 Beclometasone 0.025% 3433 Te-De-V Tablets Clotrimazole 100mg POM Tablet Vaginal 228/003 Lincoln Pharmaceuticals Ltd, India Vivian Gel Diclofenac 1.16% + P Gel Topical 228/004 Lincoln Pharmaceuticals Ltd, India Linseed Oil 3% + Methy Salicylate 10% + Menthol 3434 5% 3435 Neovag Ointment 30g Nystatin 100,000iu POM Ointment topical 228/005 Lincoln Pharmaceuticals Ltd, India Deexa Eye Drops Dexamethasone 0.1% POM Eye Drops 228/006 Lincoln Pharmaceuticals Ltd, India 3436 w/v Deexa-N Eye Drops Dexamethasone 0.1 % POM Eye Drops 228/007 Lincoln Pharmaceuticals Ltd, India w/v + Neomycin 0.5 % 3437 w/v 3438 Omlink-20 Capsules Omeprazole 20mg POM Capsule oral 228/008 Lincoln Pharmaceuticals Ltd, India

Page 177 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 3439 Daolin-5 Tablets Glibenclamide 5mg POM Tablet Uncoated 228/009 Lincoln Pharmaceuticals Ltd, India 3440 Malarid-200 Tablets Amodiaquine 200mg POM Tablet Uncoated 228/010 Lincoln Pharmaceuticals Ltd, India Rifalin Tablets Rifampicin 150mg + POM Tablet Uncoated 228/011 Lincoln Pharmaceuticals Ltd, India 3441 Isoniazid 100mg 3442 Konazol Cream Ketoconazole 2% w/w POM Cream Topical 228/012 Lincoln Pharmaceuticals Ltd, India Cotrimoxazole Oral Suspension Trimethoprim 40mg + POM Suspension for 228/013 Lincoln Pharmaceuticals Ltd, India Sulphamethoxazole Oral Use 3443 200mg, per 5ml Compound Magnesium Aluminium Hydrochloride GS Tablet Uncoated 228/014 Lincoln Pharmaceuticals Ltd, India Triscilicate Tablets 120mg + Magnesium 3444 Trisilicate 250mg 3445 Carbamazepine Tablets Carbamazepine 200mg POM Tablet Uncoated 228/015 Lincoln Pharmaceuticals Ltd, India 3446 Frusemide Tablets Furosemide 40mg POM Tablet Uncoated 228/016 Lincoln Pharmaceuticals Ltd, India Metronidazole Suspension Metronidazole Benzoate POM Suspension for 228/017 Lincoln Pharmaceuticals Ltd, India 3447 200mg, per 5mls Oral Use Ampicillin Sodium Injection Ampicillin Sodium 500mg POM Powder for 228/018 Lincoln Pharmaceuticals Ltd, India 3448 Injection 3449 Salbutamol Tablets Salbutamol 4mg POM Tablet Uncoated 228/019 Lincoln Pharmaceuticals Ltd, India Benzyl Penicillin Injection 5MU Benzyl Penicillin 5 Mega POM Powder for 228/020 Lincoln Pharmaceuticals Ltd, India 3450 Injection 3451 Licambutol Tablets Ethambutol 800mg POM Tablet Uncoated 228/021 Lincoln Pharmaceuticals Ltd, India Perilin Injection Metoclopramide 5mg, per POM Solution for 228/022 Lincoln Pharmaceuticals Ltd, India 3452 ml Injection 3453 Ranilink 150 Tablets Ranitidine 150mg POM Tablet Uncoated 228/023 Lincoln Pharmaceuticals Ltd, India Vitamin B Complex Injection Vitamin B Complex POM Solution for 228/024 Lincoln Pharmaceuticals Ltd, India 3454 Injection 3455 Teterous-250 Capsules Tetracycline 250mg POM Capsule oral 228/025 Lincoln Pharmaceuticals Ltd, India 3456 Folic Acid Tablets Folic Acid 5mg P Tablet Uncoated 228/026 Lincoln Pharmaceuticals Ltd, India Penizin Tablets Benzathine Penicillin POM Tablet Uncoated 228/027 Lincoln Pharmaceuticals Ltd, India 3457 2.4MU Bet Cream 15g Betamethasone Valerate POM Cream Topical 228/028 Lincoln Pharmaceuticals Ltd, India 3458 0.1% Clotrilin MouthWash Clotrimazole 1% POM Solution for Oral 228/029 Lincoln Pharmaceuticals Ltd, India 3459 Use 3460 Dermofulvin Tablets Griseofulvin 125mg POM Tablet Uncoated 228/031 Lincoln Pharmaceuticals Ltd, India Hydrocortisone Sodium Injection Hydrocortisone Sodium POM Powder for 228/032 Lincoln Pharmaceuticals Ltd, India 3461 Succinate 100mg Injection Nystatin Oral Suspension Nystatin 100,000 IU, per POM Suspension for 228/033 Lincoln Pharmaceuticals Ltd, India 3462 ml Oral Use

Page 178 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 3463 Neovag vaginal Tablets Nystatin 100,000 IU POM Tablet Vaginal 228/034 Lincoln Pharmaceuticals Ltd, India 3464 Perfloxacin Tablets Perfloxacin 400mg POM Tablet Uncoated 228/035 Lincoln Pharmaceuticals Ltd, India Povidone iodine Ointment Povidone Iodine 5.0%w/w GS Ointment topical 228/036 Lincoln Pharmaceuticals Ltd, India 3465 3466 Pyrazinamide Tablets Pyrazanamide 500mg POM Tablet Uncoated 228/037 Lincoln Pharmaceuticals Ltd, India Silvo Cream Silver Sulfadiazine USP P Cream Topical 228/038 Lincoln Pharmaceuticals Ltd, India 1%w/w + Chlorhexadine 3467 Gluconate 2%w/w Diclofenac Sodium Injection Diclofenac Sodium 75mg, POM Solution for 228/039 Lincoln Pharmaceuticals Ltd, India 3468 per 3ml Injection 3469 Micolin Cream 15g Miconazole 2% POM Cream Topical 228/040 Lincoln Pharmaceuticals Ltd, India 3470 L-genta Drops Gentamycin 0.3%w/v POM Ear/Eye Drops 228/041 Lincoln Pharmaceuticals Ltd, India Allphenicol Eye Drops Chloramphenicol POM Ear/Eye Drops 228/042 Lincoln Pharmaceuticals Ltd, India 3471 0.5%w/v Bet.N Cream Betamethasone Valeate POM Cream Topical 228/043 Lincoln Pharmaceuticals Ltd, India 0.05% w/w + Neomycin 3472 Sulphate 0.5%w/w 3473 Doxycycline Capsules Doxycycline 100mg POM Capsule oral 228/044 Lincoln Pharmaceuticals Ltd, India 3474 Clotrimazole Cream Clotrimazole 1%w/w POM Cream Topical 228/045 Lincoln Pharmaceuticals Ltd, India Fortified procaine pencillin Fortified Procaine POM Powder for 228/046 Lincoln Pharmaceuticals Ltd, India 3475 Injection 2.4MU Penicillin 4MU Injection 3476 Paracetamol Tablets Paracetamol 500mg GS Tablet Uncoated 228/047 Lincoln Pharmaceuticals Ltd, India Lignocaine Injection Lignocaine 2% POM Solution for 228/048 Lincoln Pharmaceuticals Ltd, India 3477 Injection Ibun Tablets Ibuprofen 400mg + P Tablet Uncoated 228/049 Lincoln Pharmaceuticals Ltd, India 3478 Paracetamol 500mg 3479 Aminophylline Tablets Aminophylline 100mg POM Tablet Uncoated 228/050 Lincoln Pharmaceuticals Ltd, India Losa 50 Tablets Losartan Potassium USP POM Tablet Uncoated 228/051 Lincoln Pharmaceuticals Ltd, India 3480 50mg Strom Injection Tramadol Hydrochloride POM Solution for 228/052 Lincoln Pharmaceuticals Ltd, India 3481 100mg, per 2ml Injection Soludine -M Ointment Povidone Iodine USP P Ointment topical 228/053 Lincoln Pharmaceuticals Ltd, India 5%w/w + Metronidazole 3482 BP 1%w/w Dermolin GM Cream Clobetasone Propionate POM Cream Topical 228/054 Lincoln Pharmaceuticals Ltd, India 0.05% + Gentamicin Sulphate 2.00% + 3483 Miconazo 0.10%

Page 179 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Flucomol Anticold Capsules Paracetamol 500mg + POM Capsule oral 228/055 Lincoln Pharmaceuticals Ltd, India Phenylephrine 10mg + Dextromethorphan 15mg + Chlorpheniramine 2mg 3484 Flucomol Anticold Suspension (Paracetamol 250mg + POM Suspension for 228/056 Lincoln Pharmaceuticals Ltd, India Phenylephrine 5mg + Oral Use Dextromethorphan 10mg + Chlorpheniramine 2mg)/5ml 3485 Glymet -1 Tablets Glimepiride 1mg + POM Tablet Uncoated 228/057 Lincoln Pharmaceuticals Ltd, India (extended release) Metformin Hydrochloride 3486 500mg Glymet -2 Tablets Glimepiride 2mg + POM Tablet Uncoated 228/058 Lincoln Pharmaceuticals Ltd, India (extended release) Metformin Hydrochloride 3487 500mg Trioxon-O 200mg Cefixime Trihydrate USP POM Tablet Uncoated 228/059 Lincoln Pharmaceuticals Ltd, India eq. Cefixime 200mg 3488 Trioxon-O Oral Suspension Cefixime Trihydrate USP POM Suspension for 228/060 Lincoln Pharmaceuticals Ltd, India eq. Cefixime 50mg, per Oral Use 3489 5ml Trioxon-O 100mg Cefixime Trihydrate USP POM Tablet Uncoated 228/061 Lincoln Pharmaceuticals Ltd, India eq. Cefixime 100mg 3490 3491 L-Pill Tablets Misoprostal 200mcg POM Tablet Uncoated 228/062 Lincoln Pharmaceuticals Ltd, India Pentalink 40mg Tablets Pantoprazole Sodium POM Tablet Uncoated 228/063 Lincoln Pharmaceuticals Ltd, India 3492 Sesquihydrate BP 40mg Ofloque -OZ Suspension Ofloxacin BP 50mg + POM Suspension for 228/064 Lincoln Pharmaceuticals Ltd, India Ornidazole 125mg, per Oral Use 3493 5ml PA 12 Tablets Paracetamol BP 300mg P Tablet Modified 228/065 Lincoln Pharmaceuticals Ltd, India (as immediate release) + Release Paracetamol BP 700mg 3494 (as sustained release)

Page 180 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Ciprovital + Tablets Cyproheptadine P Tablet Uncoated 228/066 Lincoln Pharmaceuticals Ltd, India Hydrochloride 2mg + Thiamine Hydrochloride 1.2mg + Pyridoxine Hydrochloride BP 1.2mg + Nicotinamide 3495 Hydrochloride BP 1.2mg Ciprovital + Syrup (Cyproheptadine P Syrup 228/067 Lincoln Pharmaceuticals Ltd, India Hydrochloride 2mg + Thiamine Hydrochloride 1.2mg + Pyridoxine Hydrochloride BP 1.2mg + Nicotinamide Hydrochloride BP 1.2mg), 3496 per 5ml Losa-H Tablets Losartan Potassium USP POM Tablet Uncoated 228/068 Lincoln Pharmaceuticals Ltd, India 50mg + Hydrochlorothiazide BP 3497 12.5mg L-kelfin Tablets Sulphadoxine 500mg + P Tablet Uncoated 228/069 Lincoln Pharmaceuticals Ltd, India 3498 Pyrimethamine 25mg Gluzojoint-F Capsules Glucosamine P Capsule oral 365/001 LOK WAL DEVELOPMENT LTD. HONG 3499 Hydrochloride 750mg KONG Glugogone Capsules Bitter Melon Extract P Capsule oral 365/002 LOK WAL DEVELOPMENT LTD. HONG 3500 496.5mg KONG Refined Yunzhi Essence Yunzhi Essence 300 mg P Capsule oral 365/005L LOK WAL DEVELOPMENT LTD. HONG 3501 Capsules KONG Ginseng coffee (4 in 1) Ginseng Extract 0.2mg + P Powder for Oral 382/003 LOK WAL DEVELOPMENT LTD. HONG 3502 Coffee 2mg Solution KONG Cerebrain Tablets Gingko leaves Extract P Tablet Uncoated 382/004 LOK WAL DEVELOPMENT LTD. HONG 3503 30mg KONG 3504 Tonac -10mg Tablets Atorvastatin 10mg POM Tablet Film coated 281/001 Lupin laboratories Limited, India 3505 Ceff pead Tablets Cephalexin 125mg POM Tablet Uncoated 281/002 Lupin laboratories Limited, India 3506 Tonac-20mg Tablets Atorvastatin 20mg POM Tablet Uncoated 281/003 Lupin laboratories Limited, India Ceff Dry Syrup Cefalexin 125mg, per 5ml POM Suspension for 281/004 Lupin laboratories Limited, India 3507 Oral Use Novapime 0.5g Injection Cefepime Hydrochloride POM Solution for 281/005 Lupin laboratories Limited, India 3508 USP 500mg Injection

Page 181 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Novapime 1g Injection Cefepime Hydrochloride POM Solution for 281/006 Lupin laboratories Limited, India 3509 USP 1000mg Injection Salbair Solution Salbutamol 100mcg POM Solution for 281/012 Lupin laboratories Limited, India 3510 Inhalation Salbair-1 Solution Salbutamol 100mcg + POM Solution for 281/013 Lupin laboratories Limited, India 3511 Ipratropium 20mcg Inhalation Salbair-B Salbutamol 100mcg + POM Solution for 281/014 Lupin laboratories Limited, India 3512 Beclomethasone 50mcg Inhalation Hepp Forte Syrup Folic Acid 0.5mg + P Syrup 281/015 Lupin laboratories Limited, India Elemental Iron 50mg, 3513 per 15ml 3514 Cetil -250 Tablets Ceforoxime 250mg POM Tablet Uncoated 281/016 Lupin laboratories Limited, India 3515 Cetil -500 Tablets Ceforoxime 500mg POM Tablet Uncoated 281/017 Lupin laboratories Limited, India Odicef Injection Ceftriaxone 1g POM Powder for 281/018 Lupin laboratories Limited, India 3516 Injection 3517 Ceff-250 Capsules Cephalexin 250mg POM Capsule oral 281/019 Lupin laboratories Limited, India Novapime Injection Cefepime 1000mg POM Solution for 281/020 Lupin laboratories Limited, India 3518 Injection 3519 Ceff 500 Capsules Cephalexin 500mg POM Capsule oral 281/021 Lupin laboratories Limited, India Esiflo 125 Inhaler Salmeterol 25mcg + POM Powder for 281/022 Lupin laboratories Limited, India 3520 Fluticasone 125mcg Inhalation Esiflo 250 Inhaler Salmeterol 25mcg + POM Powder for 281/023 Lupin laboratories Limited, India 3521 Fluticasone 250mcg Inhalation 3522 Odoxil Tablets Cefadroxil 500mg POM Tablet Uncoated 281/024 Lupin laboratories Limited, India Odoxil Oral Suspension Cefradoxil 125mg/5mg POM Suspension for 281/025 Lupin laboratories Limited, India 3523 Oral Use Akurit-3 Tablets Rifampicin 150mg + POM Tablet Uncoated 281/028 Lupin laboratories Limited, India Isoniazid 75mg + 3524 Ethambutol 275mg Akurit Kids Rifampicin 60mg + POM Tablet Uncoated 281/029 Lupin laboratories Limited, India 3525 Isoniazid 30mg Akurit - Z Kids Tablets Rifampicin 60mg + POM Tablet Uncoated 281/030 Lupin laboratories Limited, India Isoniazid 30mg + 3526 Pyrazinamide 150mg Akurit-4 Tablets Rifampicin 150mg + POM Tablet Uncoated 281/031 Lupin laboratories Limited, India Isoniazid 75mg + Pyrazinamide 400mg + 3527 Ethambutol 275mg 3528 Ethambutol Tablets Ethambutol 400mg POM Tablet Uncoated 281/032 Lupin laboratories Limited, India

Page 182 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 3529 Ethide Tablets Ethionamide 250mg POM Tablet Uncoated 281/033 Lupin laboratories Limited, India Desogestrel and Ethinyl Desogestrel 0.15mg + POM Tablet Film coated 281/034 Lupin laboratories Limited, India Estradiol Tablets USP Ethinyl Estradiol 0.03mg 3530 0.15mg/0.03mg Lyforan Injection Cefotaxime 1g POM Powder for 163/001 Lyka Labs limited, India 3531 Injection 3532 Fas-3 Kit Tablets Azithromycin 2.15g POM Tablet Uncoated 163/002 Lyka Labs limited, India 3533 Lyproquin Tablets Ciprofloxacin 250mg POM Tablet Uncoated 163/003 Lyka Labs limited, India Lyramycin Injection Gentamycin 40mg, per ml POM Solution for 163/004 Lyka Labs limited, India 3534 Injection 3535 Imidil Vaginal Tablets Clotrimazole 100mg POM Tablet Uncoated 163/005 Lyka Labs limited, India 3536 Lamoxy Capsules Amoxicillin 250mg POM Capsule oral 163/006 Lyka Labs limited, India Lycortin-s-Injection Hydrocortisone 1000mg POM Powder for 163/007 Lyka Labs limited, India 3537 Injection Basin 500 Capsules Cloxacillin 250mg + POM Capsule oral 163/008 Lyka Labs limited, India 3538 Ampicillin 250mg 3539 Anquin 400 Tablets Norfloxacin 400mg POM Tablet Film coated 163/009 Lyka Labs limited, India Ampicillin Injection Ampicillin 1g POM Powder for 163/010 Lyka Labs limited, India 3540 Injection 3541 Sepexin-250 Capsules Cephalexin BP 250mg POM Capsule oral 163/011 Lyka Labs limited, India Lamoxyl Syrup Amoxicillin Trihydrate BP POM Suspension for 163/012 Lyka Labs limited, India 3542 125mg, per 5ml Oral Use Lamoxy Syrup Amoxicillin Trihydrate BP POM Powder for Oral 163/013 Lyka Labs limited, India 3543 250mg Solution Lyfaxone Injection Ceftriaxone USP 1g POM Powder for 163/014 Lyka Labs limited, India 3544 Injection Lyseptol Tablets Sulphamethoxazole POM Tablet Uncoated 163/015 Lyka Labs limited, India 400mg + Trimethoprim 3545 80mg 3546 Lanol 500 Tablets Paracetamol BP 500mg GS Tablet Uncoated 163/016 Lyka Labs limited, India Imidil Vaginal Tablets Clotrimazole USP 200mg POM Tablet Vaginal 163/017 Lyka Labs limited, India 3547 Sulfadar Tablets Sulfadoxine 500mg + P Tablet Uncoated 163/018 Lyka Labs limited, India 3548 Pyrimethamine 25mg 3549 Klox 250 Capsules Cloxacillin BP 250mg POM Capsule oral 163/019 Lyka Labs limited, India Lyproquin Tablets Ciprofloxacin USP POM Tablet Uncoated 163/020 Lyka Labs limited, India 3550 500mg Lydic Tablets Diclofenac Sodium BP P Tablet Uncoated 163/021 Lyka Labs limited, India 3551 25mg

Page 183 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Ampicillin 250 Capsules Ampicillin Trihydrate BP POM Capsule oral 206/001 Maan Pharmaceuticals Limited, India 3552 250mg Amoxicillin 250 Capsules Amoxicillin Trihydrate BP POM Capsule oral 206/002 Maan Pharmaceuticals Limited, India 3553 250mg Primacort 100 Injection Hydrocortisone 100mg, POM Powder for 192/001 Macleods Pharmaceuticals Limited, India 3554 per 10ml Injection Kanamac 1000 Injection Kanamycin 1000mg, per POM Powder for 192/002 Macleods Pharmaceuticals Limited, India 3555 10ml Injection Macox Plus 100 Tablets Isoniazid 50mg + POM Tablet Uncoated 192/003 Macleods Pharmaceuticals Limited, India 3556 Rifampicin 250mg 3557 Anti-thyrox Tablets Carbimazole 5mg POM Tablet Uncoated 192/004 Macleods Pharmaceuticals Limited, India 3558 Amlodipine Tablets Amlodipine 5mg POM Tablet Uncoated 192/005 Macleods Pharmaceuticals Limited, India 3559 Ecox 400 Tablets Ethambutol 400mg POM Tablet Uncoated 192/006 Macleods Pharmaceuticals Limited, India 3560 Macrozide 500 Tablets Pyrazinamide 500mg POM Tablet Uncoated 192/007 Macleods Pharmaceuticals Limited, India 3561 Azicure 250 Tablets Azithromycin 250mg POM Tablet Uncoated 192/008 Macleods Pharmaceuticals Limited, India 3562 Azicure 500 Tablets Azithromycin 500mg POM Tablet Uncoated 192/009 Macleods Pharmaceuticals Limited, India Azicure 200/5ml Oral Azithromycin 200mg, per POM Suspension for 192/010 Macleods Pharmaceuticals Limited, India 3563 Suspension 5ml Oral Use Chloramphenicol Sodium Chlorampehicol 1g POM Powder for 192/011 Macleods Pharmaceuticals Limited, India 3564 Injection Injection 3565 Econex 400 Tablets Ethambutol + Isoniazid POM Tablet Uncoated 192/012 Macleods Pharmaceuticals Limited, India Forecox-Trac Tablets Rifampicin + Isoniazid + POM Tablet Uncoated 192/013 Macleods Pharmaceuticals Limited, India Pyrazinamide + 3566 Ethambutol Levomac 500 I.V infusion Levofloxacin 500mg POM Solution for 192/014 Macleods Pharmaceuticals Limited, India 3567 infusion 3568 Levovac 250 Tablets Levofloxacin 250mg POM Tablet Uncoated 192/015 Macleods Pharmaceuticals Limited, India 3569 Levovac 500 Tablets Levofloxacin 500mg POM Tablet Uncoated 192/016 Macleods Pharmaceuticals Limited, India Kapocin Injection Capreomycin 1g POM Powder for 192/017 Macleods Pharmaceuticals Limited, India 3570 Injection 3571 Coxerin Tablets Cycloserine 250mg POM Tablet Uncoated 192/018 Macleods Pharmaceuticals Limited, India Macripril – 10 Tablets (Enalapril Enalapril 10mg POM Tablets Oral 192/019 Macleods Pharmaceuticals Limited, India 3572 maleate USP 10mg) Tenomac 50 Tablets (Atenolol Atenolol 50mg POM Tablets Oral 192/020 Macleods Pharmaceuticals Limited, India 3573 BP 50mg) Haloperidol Tablets (Haloperidol Haloperidol 5mg POM Tablets Oral 192/021 Macleods Pharmaceuticals Limited, India 3574 BP 5mg) Rifampicin and Isoniazid Tablets Isoniazid150mg + POM Tablet Film coated 192/023 Macleods Pharmaceuticals Limited, India 3575 Rifampicin 225mg

Page 184 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Forecox Tablets Rifampicin 150mg + POM Tablet Uncoated 192/024 Macleods Pharmaceuticals Limited, India Isoniazid 75mg + Pyrazinamide 400mg + 3576 Ethambutol 275mg 3577 Nevirapine Tablets Nevirapine 200mg POM Tablet Uncoated 192/025 Macleods Pharmaceuticals Limited, India Cotrimoxazole Tablets Sulphamethoxazole + POM Tablet Uncoated 192/026 Macleods Pharmaceuticals Limited, India 3578 Trimethoprim 480mg 3579 Lamivudine Tablets Lamivudine 150mg POM Tablet Film coated 192/027 Macleods Pharmaceuticals Limited, India Lamivudine/Zidovudine Tablets Lamivudine 150mg + POM Tablet Uncoated 192/028 Macleods Pharmaceuticals Limited, India 3580 Zidovudine 300mg 3581 Isoniazid Tablets Isoniazid 100mg POM Tablet Film coated 192/029 Macleods Pharmaceuticals Limited, India 3582 Isoniazid Tablets Isoniazid 300mg POM Tablet Film coated 192/030 Macleods Pharmaceuticals Limited, India 3583 Nifedipine BP 10mg Tablets Nifedipine 10mg POM Tablet Uncoated 192/031 Macleods Pharmaceuticals Limited, India 3584 Macrozide Tablets Pyrazinamide 400mg POM Tablet Uncoated 192/032 Macleods Pharmaceuticals Limited, India 3585 Torvast 20mg Tablets Artovastatin 20mg POM Tablet Uncoated 192/033 Macleods Pharmaceuticals Limited, India Cefolac 200 Tablets Cefixime Trihydrate POM Tablet Uncoated 192/034 Macleods Pharmaceuticals Limited, India 3586 200mg 3587 Ziidovudine 300mg Tablets Zidovudine 300mg POM Tablet Uncoated 192/035 Macleods Pharmaceuticals Limited, India 3588 Efavirenz 600mg Tablets Efavirenz 600mg POM Tablet Uncoated 192/036 Macleods Pharmaceuticals Limited, India Emtricitabine 200mg + Tenofovir Emtricitabine 200mg + POM Tablet Film coated 192/037 Macleods Pharmaceuticals Limited, India DF 300mg Tablets Tenofovir DF 300mg 3589 Tablets Rifampicin 60mg + Isoniazid Rifampicin 60mg + POM Tablet Dispersible 192/038 Macleods Pharmaceuticals Limited, India 30mg Isoniazid 30mg 3590 Dispersible tablets Rifampicin 60mg + Isoniazid Rifampicin 60mg + POM Tablet Dispersible 192/039 Macleods Pharmaceuticals Limited, India 30mg + Pyrazinamide 150mg Isoniazid 30mg + Dispersible tabl Pyrazinamide 150mg 3591 Dispersible tablet Lamivudine 300mg & Tenofovir Lamivudine 300mg + POM Tablet Uncoated 192/040 Macleods Pharmaceuticals Limited, India 3592 300mg Tablets Tenofovir 300mg tablets Lamivudine 150mg+Zidovudine Lamivudine 150mg+ POM Tablet Uncoated 192/041 Macleods Pharmaceuticals Limited, India 300mg + Nevirapine 200mg Zidovudine 300mg + Tablets Nevirapine 200mg tablets 3593 Tenofovir 300mg Tablets Tenofovir Disoproxil POM Tablet Uncoated 192/042 Macleods Pharmaceuticals Limited, India 3594 Fumarate 300mg

Page 185 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Emtricitabine 200mg + Tenofovir Emtricitabine I.H 200mg POM Tablet Uncoated 192/043 Macleods Pharmaceuticals Limited, India DF 300mg + Efavirenz 600mg + Tenofivir Diisoproxil Tablets I.H 300mg + Efavirenz 3595 600mg Lumitar Tablets Artemether 20mg + POM Tablet Uncoated 192/044 Macleods Pharmaceuticals Limited, India 3596 Lumefantrine 120mg 3597 Ethomid 250 Tablets Ethionamide 250mg POM Tablet Film coated 192/045 Macleods Pharmaceuticals Limited, India Pas Sodium Granules Para Aminosalicylate POM Powder for Oral 192/046 Macleods Pharmaceuticals Limited, India 3598 Sodium 600mg, per g Suspension Moximac Tablets Moxifloxacin POM Tablet Film coated 192/047 Macleods Pharmaceuticals Limited, India Hydrochloride Tablets 3599 400 mg Ethambutol 100 Dispersible Ethambutol POM Tablet Film coated 192/050 Macleods Pharmaceuticals Limited, India 3600 Tablets Hydrochloride 100mg Streptomycin sulphate for Streptomycin sulphate POM Powder for 192/051 Macleods Pharmaceuticals Limited, India 3601 injection BP 1000mg Injection 3602 Maxadol Tablets Paracetamol 500mg GS Tablet Uncoated 167/012 Mac's Pharmaceuticals Limited, Kenya Cofrid Tablets Extract Glycyrhh BP GS Tablet Uncoated 167/013 Mac's Pharmaceuticals Limited, Kenya 35mg + Menthol BP 10mg + Aniseed BP 0.001ml + Peppermint oil BP 0.001ml + Tincture of Capsicum BPC 0.020ml + Pini pumil oil BPC 0.001ml + Eucalyptus BP 3603 0.02ml Collagen Peptides 10g + GS 325/030L Glucosamine Sulphate Powder for Oral Orthoboon Sachets Mankind Pharma Limited 1500mg + Potassium Solution 3604 Chloride 35mg Univestin (a blend of P 325/031L Uniortho - 500 Tablets extracts of Scutellaria Tablet Uncoated Mankind Pharma Limited 3605 baicalensis) 500mg Univestin (a blend of P 325/032L Uniortho - 250 Tablets extracts of Scutellaria Tablet Uncoated Mankind Pharma Limited 3606 baicalensis) 250mg

Page 186 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Metadoxine 500mg + P 325/033L Silymarin 140mg + L- Reheptin Tablets Ornithine150mg + L- Tablet Uncoated Mankind Pharma Limited Aspartate 3mg + Pyridox 3607 1.5mg Tranexamic Acid BP POM Solution for 325/034 Texakind Injection Mankind Pharma Limited 3608 500mg Injection Manforce Condoms Strawberry GS Latex Products 325/035L Male Latex Condom Mankind Pharma Limited 3609 Flavour Manforce Condoms Mango GS Latex Products 325/036L Male Latex Condom Mankind Pharma Limited 3610 Flavour Manforce Condoms Black GS Latex Products 325/037L Male Latex Condom Mankind Pharma Limited 3611 Grapes Flavour Manforce Condoms Black GS Latex Products 325/038L Male Latex Condom Mankind Pharma Limited 3612 Chocolate Flavour Vomikind Oral Solution Ondansentron POM Solution for Oral 325/039 MANKIND PHARMA LIMITED 3613 Hydrochloride 4mg/5ml Use Pantakind 40 Tablets Pantoprazole Sodium POM Tablet Film coated 325/001 Mankind Pharma Ltd, India 3614 40mg 3615 Manforce 50 Tablets Sildenafil Citrate 50mg POM Tablet Film coated 325/002 Mankind Pharma Ltd, India 3616 Manforce 100 Tablets Sildenafil Citrate 100mg POM Tablet Film coated 325/003 Mankind Pharma Ltd, India Losakind-50 Tablets Losartan Potassium POM Tablet Uncoated 325/004 Mankind Pharma Ltd, India 3617 50mg Losakind 25 Tablets Losartan Potassium POM Tablet Uncoated 325/005 Mankind Pharma Ltd, India 3618 25mg 3619 Glimestar 4 Tablets Glimepiride 4mg POM Tablet Film coated 325/006 Mankind Pharma Ltd, India 3620 Glimestar 3 Tablets Glimepiride 3mg POM Tablet Film coated 325/007 Mankind Pharma Ltd, India 3621 Glimestar 2 Tablets Glimepiride 2mg POM Tablet Film coated 325/008 Mankind Pharma Ltd, India 3622 Glimestar 1 Tablets Glimepiride 1mg POM Tablet Film coated 325/009 Mankind Pharma Ltd, India Moxikind - CV 625 Tablets Amoxicillin Trihydrate BP POM Tablet Film coated 325/010 Mankind Pharma Ltd, India 500mg + Clavulanate 3623 Potassium BP 125mg Moxikind - CV Suspension Amoxicillin Trihydrate BP POM Suspension for 325/011 Mankind Pharma Ltd, India 200mg + Potassium Oral Use 3624 Clavulanate BP 28.50mg Moxikind - CV 375 Tablets Amoxicillin Trihydrate BP POM Tablet Uncoated 325/012 Mankind Pharma Ltd, India 250mg + Clavulanate 3625 Potassium BP 125mg 3626 Rabekind -20 tablet Rabeprazole 20mg POM Tablet Uncoated 325/013 Mankind Pharma Ltd, India

Page 187 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Vomikind Injection Ondasetron POM Solution for 325/014 Mankind Pharma Ltd, India 3627 Hydrochloride USP 2mg Injection 3628 Deoregdina Tablets Levonorgestrel 1.5mg POM Tablet Uncoated 325/015 Mankind Pharma Ltd, India 3629 Ominext -20 Capsules Omeprazole BP 20mg POM Capsule oral 325/016 Mankind Pharma Ltd, India Nuforce G Cream Betamethasone POM Cream Topical 325/017 Mankind Pharma Ltd, India Dipropionate BP 0.643mg + Clotrimazole BP 10mg + Gentamycin 1mg 3630 Losakind - H Tablets Losartan Potassium USP POM Tablet Uncoated 325/018 Mankind Pharma Ltd, India 50mg + Hydrochlorothiazide USP 3631 25mg Cefakind 500 Tablets Cefuroxime Axetil POM Tablet Uncoated 325/019 Mankind Pharma Ltd, India 3632 500mg Cefakind 250 Tablets Cefuroxime Axetil POM Tablet Uncoated 325/020 Mankind Pharma Ltd, India 3633 250mg Terbinaforce - 250 Tablets Terbinafine POM Tablet Uncoated 325/021 Mankind Pharma Ltd, India Hydrochloride USP 3634 250mg Clopikind - 75 Tablets Clopidogrel Bisulphate POM Tablet Film coated 325/022 Mankind Pharma Ltd, India 3635 USP 75mg Ceftatime SB 1.5 Injection Ceftriaxone USP 1000mg POM Powder for 325/023 Mankind Pharma Ltd, India + Sulbactum Sodium Injection 3636 USP 500mg Ceftatime -1000 Injection Ceftriaxone USP 1000mg POM Powder for 325/024 Mankind Pharma Ltd, India 3637 Injection Levostand 500 Tablets Levofloxacin POM Tablet Uncoated 325/025 Mankind Pharma Ltd, India 3638 Hemihydrate 500mg Zadiways - 500 Tablets Azithromycin POM Tablet Uncoated 325/026 Mankind Pharma Ltd, India 3639 Dihydrochloride 500mg Zadiways - 250 Tablets Azithromycin POM Tablet Uncoated 325/027 Mankind Pharma Ltd, India 3640 Dihydrochloride 250mg Ubinex-LC Tablets L-Carnitine L-Tatrate Pharmacy Tablet Film coated 325/028L Mankind Pharma Ltd, India 735mg + Ubidecarenone Medicine 3641 30mg Ovagrace Sachets Myo-inositol 2000mg + Pharmacy Powder for Oral 325/029L Mankind Pharma Ltd, India Folic Acid 0.3mg + Medicine Solution 3642 Vitamin D3 8mg

Page 188 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER TOTACEF 1000 Powder for Cefepime hydrochloride POM Powder for 325/040 Mankind Pharma Ltd, India injection USP eq. to Cefepime Injection 3643 1000mg Candican liquid Infusion Fluconazole 200mg, per POM Solution for 186/002 Marck Biosciences Ltd, India 3644 100ml infusion Mannitol Intravenous Solution Mannitol 20g, per 100ml POM Solution for 186/004 Marck Biosciences Ltd, India 3645 infusion Sterilised Water BP Sterlised Water POM Solution for 186/005 Marck Biosciences Ltd, India 3646 Injection 3647 Paracetin Eye Drops Chloramphenicol 0.5% POM Eye Drops 186/009 Marck Biosciences Ltd, India Septimar Tablets Sulphamethoxazole POM Tablet Uncoated 148/001 Mars Life Sciences Ltd, India 400mg + Trimethoprim 3648 80mg 3649 Marquinite Tablets Quinine 300mg POM Tablet Film coated 148/002 Mars Life Sciences Ltd, India 3650 O-mar Capsules Omeprazole 20mg POM Capsule oral 148/003 Mars Life Sciences Ltd, India 3651 Moxmar Capsules Amoxicillin 250mg POM Capsule oral 148/004 Mars Life Sciences Ltd, India 3652 Marthrocin Tablets Erythromycin 250mg POM Tablet Uncoated 148/005 Mars Life Sciences Ltd, India 3653 Candimar Cream Clotrimazole 1% POM Cream Topical 148/006 Mars Life Sciences Ltd, India 3654 Flumar 200 Capsules Fluconazole 200mg POM Capsule oral 148/007 Mars Life Sciences Ltd, India Marzid Injection Certazidine 1g POM Powder for 148/008 Mars Life Sciences Ltd, India 3655 Injection Resflo Granules Saccharomyces Boulardii POM Powder for Oral 148/009 Mars Life Sciences Ltd, India 3656 250mg Suspension 3657 Instakleen Hand Gel Ethyl Alcohol 96% GS Gel Topical 148/010 Mars Life Sciences Ltd, India Mardip GC Cream Clotrimazole 10mg + POM Cream Topical 148/011 Mars Life Sciences Ltd, India Gentamycin 1mg + 3658 Betamethasone 0.65mg 3659 Marixime-100 Tablets Cefixime 100mg POM Tablet Uncoated 148/012 Mars Life Sciences Ltd, India 3660 Haemar-z Capsules Haematinic Preparation P Capsule oral 148/013 Mars Life Sciences Ltd, India Marixime-200 Tablets Cefixime Trihydrate USP POM Tablet Film coated 148/014 Mars Life Sciences Ltd, India 3661 200mg Marvoran-50 Tablets Diclofenac Sodium BP P Tablet Enteric 148/015 Mars Life Sciences Ltd, India 3662 50mg Coated Atropine Injection Atropine Sulphate POM Solution for 422/007 Matindale Pharma 3663 600mcg Injection Ephedrine 30mg Injection Ephedrine Hdyrochloride POM Solution for 422/008 Matindale Pharma 3664 30mg Injection Fentanyl citrate Injection, Fentanyl Citrate 50mg/ml, POM Solution for 422/004 Matindale Pharma Ltd 3665 50mg/ml 5ml Injection

Page 189 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Fentanyl citrate Injection Fentanyl Citrate 50mg/ml, POM Solution for 422/005 Matindale Pharma Ltd 3666 10ml Injection Morphine Sulphate Injection Morphine Sulphate 10mg POM Solution for 422/006 Matindale Pharma Ltd 3667 Injection 3668 Miconaz Cream Miconazole 2%w/v POM Cream Topical 277/001 Medical Union Pharmaceuticals Ltd, Egypt 3669 Miconaz Vaginal Ovules Miconazole 400mg POM Ovule Vaginal 277/003 Medical Union Pharmaceuticals Ltd, Egypt 3670 Miconaz Oral Gel Miconazole 2%w/v POM Gel Oral 277/004 Medical Union Pharmaceuticals Ltd, Egypt Miconaz-H Emugel Hydrocortisone 10mg + POM Gel Topical 277/005 Medical Union Pharmaceuticals Ltd, Egypt 3671 Miconazole 20mg Vagyl Powder Borax 13.75mg + P Powder for Topical 277/006 Medical Union Pharmaceuticals Ltd, Egypt 3672 Sodium Chloride 8mg use Sediproct Cream Hydrocortisone 0.5% + POM Cream Topical 277/007 Medical Union Pharmaceuticals Ltd, Egypt 3673 Cinchocaine 0.5% Biovit 12 Depot Injection Folic Acid 1mg + POM Solution for 277/008 Medical Union Pharmaceuticals Ltd, Egypt Pyridoxine 20mg + Injection 3674 Hydroxocobalamin 1mg Phytovit MM Injection Phytomenadione 10mg, POM Solution for 277/009 Medical Union Pharmaceuticals Ltd, Egypt 3675 per ml Injection 3676 Zinc Olive Cream Zinc Oxide BP 10% GS Cream Topical 277/011 Medical Union Pharmaceuticals Ltd, Egypt Fantem Tablets Artemether 20mg + POM Tablet Uncoated 058/001 Medinomics Healthcare Pvt Ltd, India 3677 Lumefantrine 120mg 3678 Nevirapine Tablets Nevirapine 200mg POM Tablet Uncoated 142/001 Meditab Specialities (Pvt) Ltd, India 3679 Indinavir 400 Capsules Indinavir 400mg POM Capsule oral 142/002 Meditab Specialities (Pvt) Ltd, India 3680 Stavudine30 Capsules Stavudine 30mg POM Capsule oral 142/003 Meditab Specialities (Pvt) Ltd, India 3681 Stavudine 40 Capsules Stavudine 40mg POM Capsule oral 142/004 Meditab Specialities (Pvt) Ltd, India Medivir- L Tablets Lamivudine 300mg + POM Tablet Film coated 142/005 Meditab Specialities (Pvt) Ltd, India 3682 Zidovudine 150mg 3683 Zidovudine Capsules Zidovudine 100mg POM Capsule oral 142/006 Meditab Specialities (Pvt) Ltd, India 3684 Efavirenz Capsules Efavirenz 200mg POM Capsule oral 142/007 Meditab Specialities (Pvt) Ltd, India LSN-30 Tablets Lamivudine 150mg + POM Tablet Uncoated 142/008 Meditab Specialities (Pvt) Ltd, India Stavudine 30mg + 3685 Nevirapine 200mg Medilam S 30 Tablets Lamivudine 150mg + POM Tablet Uncoated 142/009 Meditab Specialities (Pvt) Ltd, India 3686 Stavudine 30mg Medivir LN Tablets Lamivudine 150mg + POM Tablet Uncoated 142/010 Meditab Specialities (Pvt) Ltd, India 3687 Nevirapine 200mg Medilan S-40 Tablets Lamivudine 150mg + POM Tablet Uncoated 142/011 Meditab Specialities (Pvt) Ltd, India 3688 Stavudine 40mg

Page 190 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER LSN- 40 Tablets Lamivudine 150mg + POM Tablet Uncoated 142/012 Meditab Specialities (Pvt) Ltd, India Nevirapine 200mg + 3689 Stavudine 40mg 3690 Zidovudine Tablets Zidovudine 300mg POM Tablet Film coated 142/013 Meditab Specialities (Pvt) Ltd, India 3691 Codeine Phosphate Tablets Codeine 30mg POM Tablet Uncoated 048/002 Mediwin Pharmaceuticals , India Ciprogun TZ Tablets Ciprofloxacin 600mg + POM Tablet Uncoated 048/003 Mediwin Pharmaceuticals , India 3692 Tindazole 500mg Medizox Tablets Paracetamol 325mg + P Tablet Uncoated 048/004 Mediwin Pharmaceuticals , India Diclofenac 50mg + 3693 Chlorzoxane 250mg 3694 Celexin 250mg Capsules Cefalexin 250mg POM Tablet Uncoated 048/005 Mediwin Pharmaceuticals , India 3695 Lomexel Tablets Lomefloxacin 400mg POM Tablet Uncoated 106/001 Medley Pharmaceuticals Limited, India 3696 Helmintol Tablets Mebendazole 100mg P Tablet Uncoated 106/002 Medley Pharmaceuticals Limited, India Axane Gel Methyl Salicylate 50mg + GS Gel Topical 106/003 Medley Pharmaceuticals Limited, India Camphors 25mg + Menthol 25mg + Capsaicin 0.25mg, per 1g 3697 R B tone Capsules Ferrous Gluconate POM Capsule oral 106/004 Medley Pharmaceuticals Limited, India 259mg + Folic Acid 5mg + Dibasic Calcium Ohosph. 100mg + Zinc Sulp. 33mg + Vit B12 3698 2.5mcg Prosup Syrup B Complex + Protein + POM Syrup 106/005 Medley Pharmaceuticals Limited, India 3699 Vitamin 3700 Encardil 2.5 Tablets Enalapril 2.5mg POM Tablet Uncoated 106/006 Medley Pharmaceuticals Limited, India 3701 Encardil 5 Tablets Enalapril 5mg POM Tablet Uncoated 106/007 Medley Pharmaceuticals Limited, India 3702 Encardil 10 Tablets Enalapril 10mg POM Tablet Uncoated 106/008 Medley Pharmaceuticals Limited, India 3703 Encardil 20 Tablets Enalapril 20mg POM Tablet Uncoated 106/009 Medley Pharmaceuticals Limited, India 3704 Astem Tablets Astemizole 10mg POM Tablet Uncoated 106/010 Medley Pharmaceuticals Limited, India 3705 Gromin Syrup Minerals + Multivitamins P Syrup 106/011 Medley Pharmaceuticals Limited, India Xymex Syrup Riboflavin + Thiamine + P Syrup 106/012 Medley Pharmaceuticals Limited, India 3706 Fungal + Pepsin Geramed Injection Gentamicin 80mg, per POM Solution for 106/015 Medley Pharmaceuticals Limited, India 3707 2ml Injection Deximed Injection Dexamethasone 4mg POM Powder for 106/016 Medley Pharmaceuticals Limited, India 3708 Injection 3709 Moxmed-250 Capsules Amoxicillin 250mg POM Capsule oral 106/018 Medley Pharmaceuticals Limited, India

Page 191 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 3710 Ultigra-180 Tablets Fexofenadine 180mg POM Tablet Uncoated 106/019 Medley Pharmaceuticals Limited, India 3711 Oncet 10 Tablets Cetirizine 10mg POM Tablet Uncoated 106/020 Medley Pharmaceuticals Limited, India Helmintol Suspension Mebendazole 100mg, per P Suspension for 106/021 Medley Pharmaceuticals Limited, India 3712 5ml Oral Use 3713 Zoxil 500 Tablets Cefadroxil 500mg POM Tablet Uncoated 106/022 Medley Pharmaceuticals Limited, India 3714 Zoxil dt Tablets Cefadroxil 250mg POM Tablet Uncoated 106/023 Medley Pharmaceuticals Limited, India 3715 Spocelin 250 Capsules Cephalexin 250mg POM Capsule oral 106/024 Medley Pharmaceuticals Limited, India 3716 Ofoxin 200 Tablets Ofloxacin 200mg POM Tablet Uncoated 106/025 Medley Pharmaceuticals Limited, India 3717 Primodil 5 Tablets Amlodipine 5mg POM Tablet Uncoated 106/026 Medley Pharmaceuticals Limited, India 3718 Lansoprazole Capsules Lansoprazole 30mg POM Capsule oral 106/027 Medley Pharmaceuticals Limited, India 3719 Rofexib 25 Tablets Rofecoxib 25mg POM Tablet Uncoated 106/028 Medley Pharmaceuticals Limited, India 3720 Cefo L-200 Tablets Cefixime 200mg POM Tablet Uncoated 106/029 Medley Pharmaceuticals Limited, India 3721 Cefo L-100 Tablets Cefixime 100mg POM Tablet Uncoated 106/030 Medley Pharmaceuticals Limited, India 3722 Pantaz Tablets Pantoprazole 40mg POM Tablet Uncoated 106/031 Medley Pharmaceuticals Limited, India Ceftriaxone Injection Ceftriaxone 1g POM Powder for 106/032 Medley Pharmaceuticals Limited, India 3723 Injection 3724 Primodil 10 Tablets Amlodipine 10mg POM Tablet Uncoated 106/033 Medley Pharmaceuticals Limited, India 3725 Ofloxin 400 Tablets Ofloxacin 400mg POM Tablet Uncoated 106/034 Medley Pharmaceuticals Limited, India 3726 Ultigra 120 Tablets Fexofenadine 120mg POM Tablet Uncoated 106/035 Medley Pharmaceuticals Limited, India 3727 Ecoflox -500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 106/036 Medley Pharmaceuticals Limited, India 3728 Ecoflox-250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 106/037 Medley Pharmaceuticals Limited, India 3729 Decifen SR Tablets Diclofenac 100mg P Tablet Film coated 106/038 Medley Pharmaceuticals Limited, India 3730 Floxilet 300 Tablets Norfloxacin 400mg POM Tablet Uncoated 106/039 Medley Pharmaceuticals Limited, India 3731 Spocelin 500 Capsules Cephalexin 500mg POM Capsule oral 106/040 Medley Pharmaceuticals Limited, India 3732 Rofexib 12.5 Tablets Rofecoxib 12.5mg POM Tablet Uncoated 106/041 Medley Pharmaceuticals Limited, India 3733 Vasortan-50 Tablets Losartan 50mg POM Tablet Uncoated 106/042 Medley Pharmaceuticals Limited, India 3734 Glucozid Tablets Gliclazide 80mg POM Tablet Uncoated 106/043 Medley Pharmaceuticals Limited, India Zoxil 125 Rediuse Suspension Cefadroxil 125mg, per POM Suspension for 106/044 Medley Pharmaceuticals Limited, India 3735 5ml Oral Use GTN Spray Glyceryltrinitrate 0.4mg, POM Solution for 106/045 Medley Pharmaceuticals Limited, India 3736 per Metered Dose Inhalation Spasmonorm Tablets Paracetamol + P Tablet Uncoated 106/046 Medley Pharmaceuticals Limited, India 3737 Dicyclomine Gromin Drops Minerals + Multivitamins P Solution for Oral 106/047 Medley Pharmaceuticals Limited, India 3738 Use Motinorm Syrup Domperidone 5mg, per POM Syrup 106/048 Medley Pharmaceuticals Limited, India 3739 5ml 3740 Motinorm Tablets Domperidone 10mg POM Tablet Uncoated 106/049 Medley Pharmaceuticals Limited, India Motinorm Drops Domperidone 10mg, per POM Solution for Oral 106/050 Medley Pharmaceuticals Limited, India 3741 5ml Use

Page 192 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Trisoliv Syrup Kalmegh + Citric Acid + P Syrup 106/051 Medley Pharmaceuticals Limited, India 3742 Tricholine Citrate 500mg 3743 Poraz-20 Capsules Omeprazole 20mg POM Capsule oral 106/052 Medley Pharmaceuticals Limited, India 3744 Atorin 10 Tablets Atorvastatin 10mg POM Tablet Film coated 106/053 Medley Pharmaceuticals Limited, India 3745 BP Norm 50 Tablets Atenolol 50mg POM Tablet Uncoated 106/054 Medley Pharmaceuticals Limited, India New Tuxiril Syrup Dextromethorphan 10mg P Syrup 106/055 Medley Pharmaceuticals Limited, India + Phenylephrine 5mg + 3746 Menthol 5mg 3747 R.B.Tone Syrup Haematinic Preparation P Syrup 106/056 Medley Pharmaceuticals Limited, India Coldrid Day and Night Tablets Paracetamol 500mg+ P Tablet Uncoated 106/057 Medley Pharmaceuticals Limited, India Chlorpheniramine 2mg+ Phenylephrine 5mg+ 3748 Caffeine 15mg 3749 Atorin 50 Tablets Atorvastatin 50mg POM Tablet Uncoated 106/058 Medley Pharmaceuticals Limited, India Glucozid m Tablets Metformin 500mg + POM Tablet Uncoated 106/059 Medley Pharmaceuticals Limited, India 3750 Gliclazide 80mg Primodil AT Tablets Amlodipine 7.11mg + POM Tablet Uncoated 106/060 Medley Pharmaceuticals Limited, India 3751 Atenolol 50mg Acenac-P Tablets Paracetamol 325mg + P Tablet Uncoated 106/061 Medley Pharmaceuticals Limited, India 3752 Aceclofenac 100mg 3753 Ceurox 500 Tablets Cefuroxime 500mg POM Tablet Uncoated 106/062 Medley Pharmaceuticals Limited, India Xymex Drops Pepsin 10mg + Papain P Solution for Oral 106/063 Medley Pharmaceuticals Limited, India 6mg + Sodium Citrate Use 40mg + Weak Ginger Tincture 0.024ml + Citric 3754 8mg Cefo-L Dry Syrup Cefixime Trihydrate POM Suspension for 106/064 Medley Pharmaceuticals Limited, India 50mg + Lactic Acid Oral Use Bacillus 6000 million 3755 spore/g Vazortan-H Tablets Losartan Potassium POM Tablet Uncoated 106/065 Medley Pharmaceuticals Limited, India 50mg + Hydrochlorothiazide 3756 12.5mg Dompan- OD Tablets Domperidone 30mg + POM Tablet Uncoated 106/066 Medley Pharmaceuticals Limited, India 3757 Pantoprazole 47.360mg

Page 193 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Coldrid Syrup Cetirizine Dihydrochloride P Syrup 106/067 Medley Pharmaceuticals Limited, India 2.5mg + Phenylephrine Hydrochloride 5mg + Paracetamol 125mg 3758 Supiclox Injection Ampicillin + Cloxacillin POM Powder for 106/095 Medley Pharmaceuticals Limited, India 3759 Injection SunDe Choleclaciferol 60,000IU P Granules for Oral 106/096L Medley Pharmaceuticals Limited, India 3760 Use Emcycline 250 Capsules Tetracycline Capsules POM Capsule oral 272/001 Medopharm,India 3761 BP 250 3762 Doxicon Capsules 100mg Doxycycline 100mg POM Capsule oral 272/002 Medopharm,India Sulphadoxine + Pyrimethamine Sulphadoxine 500mg + P Tablet Uncoated 272/003 Medopharm,India 3763 USP Tablets Pyrimethamine 25mg M-Dopa Tablets Methyldopa Tablets BP POM Tablets oral 272/004 Medopharm,India 3764 250mg 3765 Nalidixic acid Nalidixic Acid 500mg POM Tablet Uncoated 272/007 Medopharm,India 3766 Amitriptyline Tablets Amitriptyline 25mg POM Tablet Uncoated 272/008 Medopharm,India 3767 Amoxicillin BP Capsules Amoxicillin 250mg POM Capsule oral 272/009 Medopharm,India 3768 Cimetidine Tablets Cimetidine 200mg POM Tablet Uncoated 272/010 Medopharm,India Co-trimoxazole Tablets Trimethoprim 80 + POM Tablet Uncoated 272/011 Medopharm,India Sulfamethoxazole 400mg 3769 3770 Cyproheptadine Tablets Cyproheptadine 4mg P Tablet Uncoated 272/012 Medopharm,India 3771 Diclofenac Tablets Diclofenac 100mg P Tablet Uncoated 272/013 Medopharm,India 3772 Griseofulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 272/014 Medopharm,India 3773 Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 272/015 Medopharm,India 3774 Norfloxacin Tablets Norfloxacin 400mg POM Tablet Uncoated 272/016 Medopharm,India 3775 Nitrofurantoin Tablets Nitrofurantoin 100mg POM Tablet Uncoated 272/017 Medopharm,India 3776 Ranitidine Tablets Ranitidine 150mg POM Tablet Uncoated 272/018 Medopharm,India Amoxicillin Suspension Amoxicillin 125mg, per POM Suspension for 272/019 Medopharm,India 3777 5ml Oral Use 3778 Ethionamide Tablets Ethionamide 250mg POM Tablet Uncoated 272/020 Medopharm,India 3779 Ofloxacin Tablets Ofloxacin 200mg POM Tablet Uncoated 272/021 Medopharm,India 3780 Medomol Tablets Paracetamol 500mg GS Tablet Uncoated 272/022 Medopharm,India Cedomox 228.5 Suspension Clavulanate 28.5mg + POM Suspension for 272/023 Medopharm,India 3781 Amoxicillin 200mg Oral Use Cledomox 375 Tablets Clavulanate 250mg + POM Tablet Uncoated 272/024 Medopharm,India 3782 Amoxicillin 125mg

Page 194 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Phenoxymethyl Penicillin Phenoxymethyl Penicillin POM Tablet Uncoated 272/026 Medopharm,India 3783 Tablets 250mg 3784 Nat B Capsules Multivitamins & Minerals P Capsule oral 355/001 Mega Lifescience PLC Osteomin Tablets Glucosamine Sulphate P Tablets uncoated 355/002 Mega Lifescience PLC 2Kcl USP 667mg eq to Glucosamine Sulphate 500mg + Chondroitin 3785 Sulphate USP 400mg 3786 Enat 400 SoftGel Capsules Vitamin E 400 I.U P Capsule oral 385/001 Mega Lifescience PLC Zeman SX Capsules Magnesium 83.52mg+ P Capsule oral 385/002 Mega Lifescience PLC Zinc 5.58mg + Vitamin 3787 B6 1.935mg 3788 Gogaz Capsules Simethicone 200mg P Capsule oral 385/003 Mega Lifescience PLC 3789 Livolin Forte Capsules Vitamins & Minerals P Capsule oral 385/004L Mega Lifescience PLC Calcivita Supplement for Calcium Supplement + P Capsule oral 385/005L Mega Lifescience PLC 3790 Children Vitamins Ginsomin Capsules Ginseng Extract 50mg+ P Capsule oral 385/006L Mega Lifescience PLC 3791 Multivitamins & Minerals Maxcal Tablets CaCO3 600mg + Vit D3 P Tablets uncoated 385/009L Mega Lifescience PLC 200 IU+ Culpric Gluconate 40mg + Mg O2m 7.5mg+ MnO2 1mg + NaTetraborate 1.8mg + 3792 Z 0.25mg Ginsomin Eve Capsules Evening Primrose Oil P Capsule oral 385/010L Mega Lifescience PLC 50mg + Ginseng Extract 3793 50mg+ Multivitamins 3794 Vitacap Softgel Capsules Multivitamin & Minerals P Capsule oral 385/011L Mega Lifescience PLC Prenatal Softgel Capsules Multivitamin & Minerals Pharmacy Capsule oral 385/012L Mega Lifescience PLC 3795 Medicine 3796 GOFEN 400 Capsules Ibuprofen USP 400mg P Capsule oral 385/013 Mega Lifescience PLC IICare capsules Bilberry extract 25mg + P Tablet Uncoated 385/014L Mega Lifescience PLC Lutein suspension15mg 3797 +Providing Lut 3798 Meldol Tablets 500mg Paracetamol 500mg GS Tablet Uncoated 008/001 Melcome Pharmaceuticals Limited Zambia Meldol Syrup (Paracetamol Paracetamol 120mg, per GS Solution for Oral 008/003 Melcome Pharmaceuticals Limited Zambia 3799 120mg, per 5ml) 5ml Use

Page 195 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Melcotrim Suspension Oral Sulphamethoxazole POM Suspension for 008/004 Melcome Pharmaceuticals Limited Zambia Suspension. 100mg + Trimethoprim Oral Use 3800 20mg Painrid Capsules Paracetamol BP 50mg + GS Capsule Oral 008/002 Melcome Pharmaceuticals Ltd, Zambia 3801 Caffiene 30mg Euthyrox 25 Levothyroxine Sodium POM Tablet Uncoated 363/007 Merck (Pty) Ltd 3802 25mcg Euthyrox 50 Levothyroxine Sodium POM Tablet Uncoated 363/008 Merck (Pty) Ltd 3803 50mcg Euthyrox 100 Levothyroxine Sodium POM Tablet Uncoated 363/009 Merck (Pty) Ltd 3804 100mcg Glucovance 500/5 film coated Metformin hydrochloride POM Tablet Film coated 363/014 Merck (Pty) Ltd tablets BP 500mg + 3805 Glibenclamide BP 5mg Betanil GM Cream Gentamycin 0.1% + POM Cream Topical 181/001 Merck Limited, India Miconazole 2% + 3806 Betamethasone 0.05% Betanil Cream Betamethasone POM Cream Topical 181/002 Merck Limited, India 3807 0.05%w/w Betanil N Cream Betamethasone 0.05% + POM Cream Topical 181/003 Merck Limited, India Neomycin Sulphate 0.5% 3808 3809 Diclofenac Diethylamine Cream Diclofenac 1% P Gel Topical 181/004 Merck Limited, India 3810 Nasivion Adult Nasal Drops Oxymetazoline 0.05% P Nasal drops 181/005 Merck Limited, India Navison Paediatric Nasal Drops Oxymetazoline 0.025% P Nasal drops 181/006 Merck Limited, India 3811 Evion 200 Capsules D-Alpha-Tocopherol POM Capsule oral 181/007 Merck Limited, India 3812 200mg Evion 400 Capsules D-Alpha-Tocopherol POM Capsule oral 181/008 Merck Limited, India 3813 400mg 3814 Evion Cream Vitamin E 1.0%w/w POM Cream Topical 181/009 Merck Limited, India Neurobion Forte Tablets Thiamine Mononitrate 10 P Tablet Uncoated 181/010 Merck Limited, India mg + Riboflavin 10 mg + Pyridoxine Hydrochloride 3 mg + Cyanocobalamin 15 mcg + Nicotinamide 45 mg + Calcium Pantothenate 50 mg 3815

Page 196 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Neurobion Forte Injection Mecobalamin 1000 mcg P Solution for 181/011 Merck Limited, India + Pyridoxine Injection Hydrochloride 100 mg + Niacinamide 100 mg, per 3816 2 ml Polybion Syrup Vit B Complex and P Syrup 181/012 Merck Limited, India 3817 Minerals Polybion Tablets Vit B Complex and P Tablet Uncoated 181/013 Merck Limited, India 3818 Minerals Glucophage 1000 Tablets Metformin Hydrochloride POM Tablet Film coated 363/001 Merck Limited, India 3819 BP 1000mg Glucophage 850 Tablets Metformin Hydrochloride POM Tablet Film coated 363/002 Merck Limited, India 3820 BP 850mg Glucophage 500 Tablets Metformin Hydrochloride POM Tablet Film coated 363/003 Merck Limited, India 3821 BP 500mg Ziak 2.5/6.25 Tablets Bisoprolol Fumarate POM Tablet Uncoated 363/004 Merck Limited, India 2.5mg + Hydrochlorothiazide 3822 6.25mg Ziak 5/6.25 Tablets Bisoprolol Fumarate 5mg POM Tablet Uncoated 363/005 Merck Limited, India + Hydrochlorothiazide 6.25mg 3823 Ziak 10/6.25 Tablets Bisoprolol Fumarate POM Tablet Uncoated 363/006 Merck Limited, India 2.5mg + Hydrochlorothiazide 3824 6.25mg 3825 Crixivan 400mg Capsules Indinavir 400mg POM Capsule oral 105/002 Merck Sharp and Dohme 3826 Stocrin 200mg Tablets Ritonavir 200mg POM Tablet Uncoated 105/003 Merck Sharp and Dohme 3827 Stocrin 600mg Tablets Ritonavir 600mg POM Tablet Uncoated 105/004 Merck Sharp and Dohme 3828 Stocrin 50mg Tablets Ritonavir 50mg POM Tablet Uncoated 105/005 Merck Sharp and Dohme Atripla Tablets Efavirenz 600mg + POM Tablet Uncoated 105/007 Merck Sharpe & Dohme (Pty) Ltd,France Emtricitabine 200mg + 3829 Tenofovir 300mg Gardasil Vaccine Human Papillomavirus 9- POM Suspension for 105/008 Merck Sharpe & Dohme (Pty) Ltd,France valent Vaccine, Injection 3830 Recombinant 3831 Isentress Tablets Raltegravir 400mg POM Tablet Film coated 105/009 Merck Sharpe & Dohme (Pty) Ltd,France

Page 197 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Implanon Implant Etonogestrel 68mg, per POM Implant 105/019 Merck Sharpe & Dohme (Pty) Ltd,France 3832 Implant Janumet 50/850 Tablets Sitagliptin 50mg + POM Tablet Enteric 105/020 Merck Sharpe & Dohme (Pty) Ltd,France Metformin Hydrochloride Coated 3833 850mg Janumet 50/1000 Tablets Sitagliptin 50mg + POM Tablet Enteric 105/021 Merck Sharpe & Dohme (Pty) Ltd,France Metformin Hdrochloride Coated 3834 1000mg 3835 Implanon NXT Implant Etonogestrel 68mg POM Implant 105/022 Merck Sharpe & Dohme (Pty) Ltd,France 3836 Januvia 25mg Tablets Sitagliptin 25mg POM Tablet Film coated 105/023 Merck Sharpe & Dohme (Pty) Ltd,France 3837 Januvia 50mg Tablets Sitagliptin 50mg POM Tablet Film coated 105/024 Merck Sharpe & Dohme (Pty) Ltd,France 3838 Januvia 100mg Tablets Sitagliptin 100mg POM Tablet Film coated 105/025 Merck Sharpe & Dohme (Pty) Ltd,France Glucovance 500/2.5 film coated Metformin hydrochloride POM Tablet Film coated 363/015 Merck Sharpe & Dohme (Pty) Ltd,France tablets BP 500mg + 3839 Glibenclamide BP 2.5mg Rol Cold Tablets Paracetamol 500mg + P Tablet Uncoated 294/001 Merit Organics Limited Phenylepherine 5mg + Caffeine 15mg + 3840 Chlorpheniramine 2mg Congestyl Tablets Paracetamol 500mg + P Tablet Uncoated 019/001 Meyer Organics Pvt Ltd, India Phenylephrine 5mg + 3841 Chlorpheniramine 4mg Fiberex Powder Ispaghula Husk 3.75 gm, GS Powder for Oral 019/002 Meyer Organics Pvt Ltd, India 3842 per 4.8g Suspension Gericare Capsules Magnesium Hydroxide P Capsule oral 019/003 Meyer Organics Pvt Ltd, India 40mg + Vitamins + 3843 Minerals) Kidcare Plus Syrup Multivitamins + Lysine GS Syrup 019/004 Meyer Organics Pvt Ltd, India 3844 40mg + Minerals Lactulin liquid Concentrate Lactulose 10g + P Solution for Oral 019/005 Meyer Organics Pvt Ltd, India 3845 Riboflavin 0.6mg Use Mim Capsules Magnesium Hydroxide GS Capsule oral 019/006 Meyer Organics Pvt Ltd, India 72mg + Vitamins + 3846 Minerals Mim Organic Tonic Minerals + Multivitamins P Solution for Oral 019/007 Meyer Organics Pvt Ltd, India 3847 Use 3848 Motionil Capsules Loperamide 2mg POM Capsule oral 019/008 Meyer Organics Pvt Ltd, India 3849 Wingora Tablets Sildenafil 50mg POM Tablet Uncoated 019/009 Meyer Organics Pvt Ltd, India 3850 Lomez Capsules Omeprazole 20mg POM Capsule oral 019/010 Meyer Organics Pvt Ltd, India

Page 198 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Aloesilk Cream Vitamin A 1000IU + Aloe P Cream Topical 019/011 Meyer Organics Pvt Ltd, India 3851 Vera Extracts Babygesic Drops Paracetamol 100mg, per GS Solution for Oral 019/012 Meyer Organics Pvt Ltd, India 3852 ml Use Candifem Vaginal Tablets Miconazole 100mg + POM Tablet Vaginal 019/013 Meyer Organics Pvt Ltd, India 3853 Ornidazole 500mg Congestyl Syrup Paracetamol 125mg + P Syrup 019/014 Meyer Organics Pvt Ltd, India Phenylephrine 2.5mg + Chlorpheniramine 1.5mg 3854 + Menthol 1mg, per 5ml 3855 Ugesic Tablets Piroxicam 20mg POM Capsule oral 019/015 Meyer Organics Pvt Ltd, India Colicaid Drops Simethicone 40mg + Dill P Solution for Oral 019/016 Meyer Organics Pvt Ltd, India Oil 0.005ml + Fennel Oil Use 3856 0.0007ml, per ml Fevril Suspension Paracetamol 125 mg + P Suspension for 019/017 Meyer Organics Pvt Ltd, India Promethazine 2.5mg, per Oral Use 3857 5ml Fairyl Cream (Vitamin E 1% + Vitamin P Cream Topical 019/018 Meyer Organics Pvt Ltd, India A 1000IU + Zinc oxide 3858 4%), per g Zedcal Tablets Calcium Carbonate P Tablet Uncoated 019/019 Meyer Organics Pvt Ltd, India 250mg + Zinc Sulphate 7.5mg + Calciferol 3859 0.25mg 3860 Coldcare Tablets Multivitamins + Minerals GS Tablet Uncoated 019/020 Meyer Organics Pvt Ltd, India Gastracid liquid Calcium Carbonate P Suspension for 019/021 Meyer Organics Pvt Ltd, India 400mg + Magnesium Oral Use Hydroxide 120mg + Magnesium Trisilicate 50mg + Simethicone 3861 83mg 3862 Oligocare Capsules Multivitamins GS Capsule oral 019/022 Meyer Organics Pvt Ltd, India 3863 Ovacare Capsules Multivitamins GS Capsule oral 019/023 Meyer Organics Pvt Ltd, India 3864 Ultimale Capsules Herbal Extracts P Capsule oral 019/024 Meyer Organics Pvt Ltd, India Zithrocare-250 Tablets Azithromycin Dihydrate POM Tablet Uncoated 019/025 Meyer Organics PVT LTd, India 3865 250mg Zithrocare-500 Tablets Azithromycin Dihydrate POM Tablet Uncoated 019/026 Meyer Organics PVT LTd, India 3866 500mg

Page 199 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Uvex- 500 Tablets Levofloxacin POM Tablet Uncoated 019/027 Meyer Organics PVT LTd, India 3867 Hemihydrate 500mg Uvex- 750 Tablets Levofloxacin POM Tablet Uncoated 019/028 Meyer Organics PVT LTd, India 3868 Hemihydrate 750mg Cofaid Liquid Solution Herbal Extracts POM Solution for Oral 019/HM001 Meyer Organics Pvt Ltd, India 3869 Use Ornilox Tablets Ornidazole 500mg + POM Tablet Uncoated 315/001 Micro labs Limited, India 3870 Ofloxacin 200mg Levobact 750 Tablets Levofloxacin POM Tablet Uncoated 315/003 Micro labs Limited, India 3871 Hemihydrate 750mg Clariwin 500 Tablets Clarithromycin USP POM Tablet Uncoated 315/004 Micro labs Limited, India 3872 500mg Bactoclave 562.5 Tablets Amoxicillin Trihydrate BP POM Tablet Uncoated 315/005 Micro labs Limited, India 500mg + Potassium 3873 Clavulanate 62.5mg Bactoclave 112.5 Dry Syrup Amoxicillin Trihydrate BP POM Powder for Oral 315/006 Micro labs Limited, India 100mg + Potassium Suspension 3874 Clavulanate 12.5mg Bactoclave 1000 Tablets Amoxicillin Trihydrate POM Tablet Film coated 315/007 Micro labs Limited, India 875mg + Clavulanate 3875 Potassium 125mg 3876 Arbitel 80 Tablets Telmisartan USP 80mg POM Tablet Uncoated 315/008 Micro labs Limited, India Nebilong Tablets Nebivolol Hydrochloride POM Tablet Uncoated 315/009 Micro labs Limited, India 3877 5mg Nebilong - H Tablets Nebivolol Hydrochloride POM Tablet Uncoated 315/010 Micro labs Limited, India 5mg + Hydrochlorothiazide 3878 12.5mg Alendro Tablets Alendronate Sodium USP POM Tablet Uncoated 315/011 Micro labs Limited, India 3879 70mg Micropime Injection Cefeprime Hydrochloride POM Powder for 315/012 Micro labs Limited, India 3880 USP 1g Injection 3881 Prednisolone Tablets Prednisolone 5mg POM Tablet Uncoated 315/013 Micro labs Limited, India Cotrimoxazole Tablets Trimethoprim BP 80mg + POM Tablet Uncoated 315/014 Micro labs Limited, India Sulphamethoxazole BP 3882 400mg Nebilong -AM Tablets Nebivolol Hydrochloride POM Tablet Uncoated 315/015 Micro labs Limited, India 5mg + Amlodipine 3883 Besylate 5mg

Page 200 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Amlozaar Tablets losartan Potassium 50mg POM Tablet Uncoated 315/016 Micro labs Limited, India + Amilodipine Besilate 3884 5mg Amlozaar -H Tablets losartan Potassium 50mg POM Tablet Uncoated 315/017 Micro labs Limited, India + Amilodipine Besilate 5mg + Hydrochlorothiazide 3885 12.5mg Doxycycline Hyclate USP Doxcycline Hyclate USP POM Tablet Uncoated 315/018 Micro labs Limited, India 3886 Tablets 100mg Doxycycline Capsules BP Doxcycline Hyclate BP POM Capsule oral 315/019 Micro labs Limited, India 3887 100mg Nugrel A Plus Tablets Clopidogrel Bisulfate POM Tablet Film coated 315/020 Micro labs Limited, India USP 75mg + Aspirin BP 3888 100mg 3889 Mebux 80 Tablets Febuxostat 80mg POM Tablet Uncoated 315/021 Micro labs Limited, India 3890 Mebux 40 Tablets Febuxostat 40mg POM Tablet Uncoated 315/022 Micro labs Limited, India Gramocef-O-100 Dry Syrup Cefixime Trihydrate USP POM Powder for Oral 315/023 Micro labs Limited, India 3891 100mg, per 5ml Suspension Gramocef-O-200 Capsules Cefixime Trihydrate USP POM Capsule oral 315/024 Micro labs Limited, India 3892 200mg Dolosip-Z Tablets Paracetamol BP 500mg + P Tablet Film coated 315/025 Micro labs Limited, India Phenylephrine HCl BP 5 mg + Caffeine BP 25mg 3893 Clariwin ER Tablets Clarithromycin USP POM Tablet Film coated 315/026 Micro labs Limited, India 3894 500mg Arbitel-AV Tablets Telmisartan 40 mg + POM Tablet Uncoated 315/027 Micro labs Limited, India Atorvastatin 10mg 3895 Tablets 3896 Arbitel Tablets Telmisartan USP 40mg POM Tablet Uncoated 315/028 Micro labs Limited, India Ethionamide 250 Tablets Ethionamide USP 250mg POM Tablet Uncoated 315/029 Micro labs Limited, India 3897 Bonair HFA Inhaler Salbutamol 100mcg POM Powder for 297/001 Midas- Care Pharmaceuticals Pvt Limited 3898 Inhalation X-Cite Spray (Lidocaine USP) Lidocaine Hydrochloride POM Spray for Topical 279/009 Midas- Care Pharmaceuticals Pvt Limited, 3899 1.5mg Use India Besone 250 HFA Inhaler Beclomethasone POM Solution for 297/002 Midas- Care Pharmaceuticals Pvt Limited, 3900 Dipropionate 250mcg Inhalation India

Page 201 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Mistdress Spray Lidocaine Hydrochloride POM Spray for Topical 297/003 Midas- Care Pharmaceuticals Pvt Limited, 1.0%w/w + Cetrimide Use India 3901 1.0%w/w Flusal 50 HFA Inhaler Salmeterol Xinafoate POM Solution for 297/004 Midas- Care Pharmaceuticals Pvt Limited, 25mcg + Fluticasone Inhalation India 3902 Propionate 50mcg Flusal 125 HFA Inhaler Salmeterol Xinafoate POM Solution for 297/005 Midas- Care Pharmaceuticals Pvt Limited, 25mcg + Fluticasone Inhalation India 3903 Propionate 125mcg Flusal 250 HFA Inhaler Salmeterol Xinafoate POM Solution for 297/006 Midas- Care Pharmaceuticals Pvt Limited, 25mcg + Fluticasone Inhalation India 3904 Propionate 250mcg Coolex Spray Lidocaine Hydrochloride POM Spray for Topical 297/007 Midas- Care Pharmaceuticals Pvt Limited, 3.0%w/v + Use India Benzethonium Chloride 3905 0.2%w/v Vinodine Spray Povidone Iodine 5.0%w/v P Solution for Topical 297/008 Midas- Care Pharmaceuticals Pvt Limited, 3906 Use India Relispray -Ayurvedic Pain Relief Herbal Preparation GS Spray for Topical 297/010 Midas- Care Pharmaceuticals Pvt Limited, 3907 Spray Use India Antim Tablets Pyrimthamine25mg + POM Tablet Uncoated 170/001 Mihika Pharmaceuticalds Ltd, India 3908 Sulfadoxine 500mg Effecip-500 Tablets Ciprofloxacin USP POM Tablet Uncoated 170/002 Mihika Pharmaceuticalds Ltd, India 3909 500mg 3910 Acyclex 200mg Tablets Acyclovir 200mg POM Tablet Uncoated 170/003 Mihika Pharmaceuticalds Ltd, India 3911 Dermiral 200 Tablets Ketoconazole 200mg POM Tablet Uncoated 170/004 Mihika Pharmaceuticalds Ltd, India 3912 Zolmed 150 Tablets Fluconazole 150mg POM Tablet Uncoated 170/005 Mihika Pharmaceuticalds Ltd, India 3913 Actiflam 200 Tablets Ibuprofen BP 200mg P Tablet Uncoated 170/006 Mihika Pharmaceuticalds Ltd, India Endorm-100 Tablets Mebendazole USP P Tablet Uncoated 170/007 Mihika Pharmaceuticalds Ltd, India 3914 100mg 3915 Mihizole 200 Tablets Metronidazole 200mg POM Tablet Uncoated 170/008 Mihika Pharmaceuticalds Ltd, India Cloxasafe 250 Capsules Cloxacillin Sodium BP POM Capsule oral 170/009 Mihika Pharmaceuticalds Ltd, India 3916 250mg Novoxi Oral Suspension Amoxicillin 125mg, per POM Suspension for 170/010 Mihika Pharmaceuticalds Ltd, India 3917 5ml Oral Use 3918 Ompalen 20mg Capsules Omeprazole 20mg POM Capsule oral 170/012 Mihika Pharmaceuticalds Ltd, India Spasmorid-10mg Tablets Hyoscine Butylbromide P Tablet Film coated 170/013 Mihika Pharmaceuticalds Ltd, India 3919 10mg

Page 202 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Voltika 50 Tablets Diclofenac Sodium 50mg P Tablet Enteric 170/014 Mihika Pharmaceuticalds Ltd, India 3920 Coated 3921 Histergan 25 Tablets Promethazine 25mg P Tablet Film coated 170/016 Mihika Pharmaceuticalds Ltd, India Mihizole Oral Suspension Metronidazole Benzoate POM Suspension for 170/017 Mihika Pharmaceuticalds Ltd, India 3922 BP 125mg, per 5ml Oral Use Mahitrim Suspension Sulfamethoxazole 200mg POM Suspension for 170/018 Mihika Pharmaceuticalds Ltd, India + Trimethoprim 40mg, Oral Use 3923 per 5ml Betrim Tablets Sulfamethoxazole 400mg POM Tablet Uncoated 280/004 Milan Laboratories Pvt Ltd, India + Trimethoprim 80mg 3924 3925 Milzor Tablets Paracetamol 500mg GS Tablet Uncoated 280/005 Milan Laboratories Pvt Ltd, India ML-Cotri Suspension Sulfamethoxazole 200mg POM Suspension for 280/006 Milan Laboratories Pvt Ltd, India + Trimethoprim 40mg, Oral Use 3926 per 5ml ML-Metro Suspension Metronidazole 125mg, POM Suspension for 280/007 Milan Laboratories Pvt Ltd, India 3927 per 5ml Oral Use 3928 Streptol Cough lozenges Menthol + Eucalyptus Oil GS Lozenges 280/008 Milan Laboratories Pvt Ltd, India 3929 Milmaleate Tablets Chlorpheniramine 4mg P Tablet Uncoated 280/009 Milan Laboratories Pvt Ltd, India 3930 Furosimide Tablets Furosemide 40mg POM Tablet Uncoated 280/010 Milan Laboratories Pvt Ltd, India 3931 Clonex Cream Clotrimazole 1%w/w POM Cream Topical 280/011 Milan Laboratories Pvt Ltd, India Miloxy Oral Suspension Amoxicillin 125mg, per POM Powder for Oral 280/012 Milan Laboratories Pvt Ltd, India 3932 5ml Suspension Milpol Syrup Paracetamol 120mg, per GS Syrup 280/013 Milan Laboratories Pvt Ltd, India 3933 5ml 3934 ML - Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 280/014 Milan Laboratories Pvt Ltd, India Phenoxymethyl Penicillin Oral Phenoxymethyl Penicillin POM Powder for Oral 280/015 Milan Laboratories Pvt Ltd, India Suspension Potassium 125mg, per Suspension 3935 5ml 3936 Diclofenac Sodium Tablets Diclofenac 50mg P Tablet Uncoated 280/016 Milan Laboratories Pvt Ltd, India 3937 Diclofenac Gel Diclofenac 1%w/w P Gel Topical 280/017 Milan Laboratories Pvt Ltd, India Milclox Capsules Ampicillin 250mg + POM Capsule oral 280/018 Milan Laboratories Pvt Ltd, India 3938 Cloxacillin 250mg Phenoxymethyl Penicillin Phenoxymethyl Penicillin POM Tablet Uncoated 280/019 Milan Laboratories Pvt Ltd, India 3939 Potassium Tablets 250mg 3940 Heptovit Softgel Capsules Herbal Phytomedicine GS Capsule oral 373/001 Millenium Herbal Care Ltd Amoxicillin Oral Suspension Amoxiclllin 125mg, per POM Suspension for 144/045 Mission Pharma A/S, Denmark 3941 5ml Oral Use 3942 Amoxicillin Capsules Amoxicillin 250mg POM Capsule oral 144/046 Mission Pharma A/S, Denmark

Page 203 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Oral Rehydration Salts Sodium Chloride 2.6g + GS Powder for Oral 144/047 Mission Pharma A/S, Denmark Potassium Chloride 1.5g Solution + Sodium Citrate 2.9g + Anhydrous Glucose 3943 13.5g Nystatin Pessaries BP Nystatin 100,000IU POM Tablet Vaginal 144/048 Mission Pharma A/S, Denmark 3944 100,000IU Paracetamol Tablets BP 500mg Paracetamol 500mg P Tablet Uncoated 144/049 Mission Pharma A/S, Denmark 3945 3946 Amoxicillin Tablets USP 250mg Amoxicillin 250mg POM Tablet Uncoated 144/050 Mission Pharma A/S, Denmark 3947 Salbutamol Tablets BP 4mg Salbutamol 4mg POM Tablet Uncoated 144/051 Mission Pharma A/S, Denmark 3948 Amoxicillin Tablets USP 250mg Amoxicillin 250mg POM Tablet Uncoated 144/052 Mission Pharma A/S, Denmark Triclovera Injection Medroxyprogesterone POM Solution for 144/053 Mission Pharma A/S, Denmark 3949 150mg, per ml (1ml) Injection 3950 Nystatin Vaginal Inserts Nystatin USP 100,000IU POM Tablet Vaginal 144/055 Mission Pharma A/S, Denmark Dextrose 50 Injection Dextrose USP 50% POM Solution for 144/056 Mission Pharma A/S, Denmark 3951 Injection Benzylpenicilline 1M Benzyl penicillin 1MIU POM Powder for 144/057 Mission Pharma A/S, Denmark 3952 Injection Sterilised Water For Injection Water for Injections 5ml POM Solution for 144/058 Mission Pharma A/S, Denmark 3953 Injection Sterilised Water For Injection Water for Injections 10ml POM Solution for 144/059 Mission Pharma A/S, Denmark 3954 Injection Nystatin Oral Suspension Nystatin 100 000 IU POM Suspension for 144/063 Mission Pharma A/S, Denmark 3955 Oral Use 3956 Metronidazole 200 Tablets Metronidazole 200mg POM Tablet Uncoated 144/064 Mission Pharma A/S, Denmark Salbutamol 4 Tablets Salbutamol Sulfate BP POM Tablet Uncoated 144/065 Mission Pharma A/S, Denmark 3957 4mg POM 144/066 Metronidazole Tablets Metronidazole BP 200mg Tablet Film coated Mission Pharma A/S, Denmark 3958 3959 Male Latex Condoms Male Latex Condoms GS Latex Products 144/066L Mission Pharma A/S, Denmark Chlopheniramine Maleate P 144/067 Chlopheniramine Tablets Tablet Uncoated Mission Pharma A/S, Denmark 3960 4 mg 3961 Male Latex Condoms Male Latex Condoms GS Latex Products 144/067L Mission Pharma A/S, Denmark Quinine Sulphate BP POM 144/068 Quinine 300mg Tablet Film coated Mission Pharma A/S, Denmark 3962 300mg Salbutamol Tablets BP 4 POM 144/069 Salbutamol Tablets BP 4 mg Tablet Uncoated Mission Pharma A/S, Denmark 3963 mg

Page 204 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Erythromycin Stearate POM 144/070 Erythromycin Stearate Tablets Tablet Film coated Mission Pharma A/S, Denmark 3964 BP 250 mg Tetracycline Hydrochloride Tetracycline POM 144/071 Ointment topical Mission Pharma A/S, Denmark 3965 Ophthalmic Ointment Hydrochloride USP 1% Phenoxymethylpenicillin Tablets Phenoxymethylpenicillin POM 144/072 Tablet Uncoated Mission Pharma A/S, Denmark 3966 BP BP 250mg Quinine Sulphate Tablets BP Quinine Sulphate BP POM 144/073 Tablet Film coated Mission Pharma A/S, Denmark 3967 300mg 300mg Ceftriaxone Powder For Ceftriaxone Sodium POM Powder for 144/074 Mission Pharma A/S, Denmark 3968 Injection 250mg Injection Water for Injection POM Solution for 144/075 Sterilised Water for Injection Mission Pharma A/S, Denmark 3969 infusion Pethidine 50 Injection Pethidine 50mg/ml POM Solution for 422/001 Mission Pharma A/S, Denmark 3970 Injection Pethidine 100 Injection Pethidine 100mg/ml) POM Solution for 422/002 Mission Pharma A/S, Denmark 3971 Injection Glycopyrronium Bromide Glycopyrronium bromide POM Solution for 422/003 Mission Pharma A/S, Denmark 3972 Injection 200mcg/ml Injection Co-trimoxazole Oral Suspension Sulphamethoxazole POM Suspension for 144/002 Missionpharma A/S, Denmark 200mg + Trimethoprim Oral Use 3973 40mg Co-trimoxazole Tablets Sulphamethoxazole POM Tablet Uncoated 144/003 Missionpharma A/S, Denmark 400mg + Trimethoprim 3974 80mg Ampicillin Oral Suspension Ampicillin 250mg, per POM Powder for Oral 144/004 Missionpharma A/S, Denmark 3975 5ml Suspension Amoxicillin Oral Suspension Amoxicillin 250mg, per POM Powder for Oral 144/005 Missionpharma A/S, Denmark 3976 5ml Suspension 3977 Metronidazole Tablets Metronidazole 250mg POM Tablet Uncoated 144/006 Missionpharma A/S, Denmark 3978 Paracetamol Tablets 1000's Paracetamol 500mg GS Tablet Uncoated 144/007 Missionpharma A/S, Denmark 3979 Ibuprofen Tablets Ibuprofen 200mg P Tablet Uncoated 144/008 Missionpharma A/S, Denmark 3980 Diclofenac Tablets Diclofenac 50mg P Tablet Uncoated 144/009 Missionpharma A/S, Denmark Sulfadoxine + Pyrimethamine Sulfadoxine 400mg + P Tablet Uncoated 144/010 Missionpharma A/S, Denmark 3981 Tablets Pyrimethamine 25mg Nystatin Oral Suspension Nystatin 100,000IU POM Suspension for 144/011 Missionpharma A/S, Denmark 3982 Oral Use Aspirin Tablets Acetyl Salicylic Acid P Tablet Uncoated 144/012 Missionpharma A/S, Denmark 3983 300mg 3984 Amoxicillin Capsules Amoxicillin 250mg POM Tablet Uncoated 144/013 Missionpharma A/S, Denmark

Page 205 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Benzathine Benzylpenicillin Benzathine POM Solution for 144/014 Missionpharma A/S, Denmark 3985 Injection 2.4MU Benzylpenicillin 2.4MU Injection Benzylpenicillin Injection 1MU Benzyl penicillin 1MU POM Solution for 144/015 Missionpharma A/S, Denmark 3986 Injection Benzylpenicillin Injection 5MU Benzyl penicillin 5MU POM Solution for 144/016 Missionpharma A/S, Denmark 3987 Injection Diazepam Injection 5m, per ml Diazepam 5mg, per ml POM Solution for 144/017 Missionpharma A/S, Denmark 3988 Injection Lidocaine Hydrochloride Lidocaine 100mg, per ml POM Solution for 144/018 Missionpharma A/S, Denmark 3989 Injection Injection 3990 Mebendazole 100mg Tablets Mebendazole 100mg P Tablet Uncoated 144/019 Missionpharma A/S, Denmark Methyllergonovine Injection Methylergonovine 0.2mg, POM Solution for 144/020 Missionpharma A/S, Denmark 3991 0.2mg, per ml per ml Injection 3992 Nitrofurantoin 50mg Tablets Nitrofurantoin 50mg P Tablet Uncoated 144/021 Missionpharma A/S, Denmark 3993 Paracetamol 500mg Tablets Paracetamol 500mg GS Tablet Uncoated 144/022 Missionpharma A/S, Denmark 3994 Chlorpheniramine 4mg Tablets Chlorpheniramine 4mg P Tablet Uncoated 144/023 Missionpharma A/S, Denmark 3995 Clotrimazole 1% Cream Clotrimazole 1%w/w POM Tablet Uncoated 144/024 Missionpharma A/S, Denmark Erythromycin Stearate 250mg Erythromycin 250mg POM Tablet Uncoated 144/025 Missionpharma A/S, Denmark 3996 Tablets 3997 Ferrous Sulphate 50mg Tablets Ferrous Sulphate 50mg P Tablet Uncoated 144/026 Missionpharma A/S, Denmark 3998 Folic Acid 5mg Tablets Folic Acid 5mg P Tablet Uncoated 144/027 Missionpharma A/S, Denmark Hydrocortisone Acetate Hydrocortisone 1% POM Ointment topical 144/028 Missionpharma A/S, Denmark 3999 Ointment 1% Compound Magnesium Dried Aluminium GS Tablet Uncoated 144/029 Missionpharma A/S, Denmark Trisilicate Tablets Hydroxide 120mg + Magnesium Trisilicate 4000 250mg 4001 Salbutamol 2mg Tablets Salbutamol 2mg POM Tablet Uncoated 144/030 Missionpharma A/S, Denmark Procain Penicillin Injection Procain Penicillin 3MU POM Solution for 144/031 Missionpharma A/S, Denmark 4002 Injection 4003 Salbutamol Tablets Salbutamol 4mg POM Tablet Uncoated 144/032 Missionpharma A/S, Denmark Phenoxymethylpenicillin Tablets Phenoxymethyl Penicillin POM Tablet Uncoated 144/033 Missionpharma A/S, Denmark 4004 V 250mg Nystatin Oral Suspension Nystatin 100 IU, per 5ml POM Suspension for 144/034 Missionpharma A/S, Denmark 4005 Oral Use 4006 Doxycycline Tablets Doxycycline 100mg POM Tablet Uncoated 144/035 Missionpharma A/S, Denmark 4007 Multivitamin Tablets Multivitamins GS Tablet Uncoated 144/036 Missionpharma A/S, Denmark Water for Injections Sterile Water for POM Solution for 144/037 Missionpharma A/S, Denmark 4008 Injections 10ml Injection

Page 206 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 4009 Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 144/038 Missionpharma A/S, Denmark 4010 Aciclovir Tablets Aciclovir BP 400mg POM Tablet Uncoated 144/039 Missionpharma A/S, Denmark Benzylpenicillin Injection Benzyl Penicillin Sodium POM Powder for 144/040 Missionpharma A/S, Denmark 4011 BP 5MIU Injection Erythromycin Tablets Erythromycin Stearate POM Tablet Uncoated 144/041 Missionpharma A/S, Denmark 4012 BP 250mg Erythromycin Suspension Erythromycin Ethyl POM Suspension for 144/042 Missionpharma A/S, Denmark Succinate USP 125mg, Oral Use 4013 per 5ml 4014 Fluconazole Tablets Fluconazole USP 200mg POM Tablet Uncoated 144/043 Missionpharma A/S, Denmark Gentamicin Injection Gentamicin BP 40ml, per POM Solution for 144/044 Missionpharma A/S, Denmark 4015 2ml Injection 4016 Multivitamin Tablets Multivitamin P Tablet Film coated 144/054 Missionpharma A/S, Denmark 4017 Lofin 500 Tablets Metformin 500mg POM Tablet Uncoated 062/001 MJ Biopharm Pvt Limited Biosulin N Injection Insulin Isophane 100IU, POM Solution for 062/002 MJ Biopharm Pvt Limited 4018 per 10ml Injection Biosulin R Injection Insulin Soluble 100IU, per POM Solution for 062/003 MJ Biopharm Pvt Limited 4019 10ml Injection Biosulin 30/70 Injection Insulin Solube EP 30% + POM Solution for 062/004 MJ Biopharm Pvt Limited 4020 Insulin Isophane EP 70% Injection 4021 Glibex 5 Tablets Glibenclamide 5mg POM Tablet Uncoated 062/005 MJ Biopharm Pvt Limited 4022 Indomethacin 25 Capsules Indomethacin 25mg P Capsule oral 062/006 MJ Biopharm Pvt Limited 4023 Allerdin Syrup Loratadine 5mg P Syrup 310/001 MMC Healthcare Limited, India Cofsy Syrup Ambroxol BP 15mg + P Syrup 310/002 MMC Healthcare Limited, India Salbutamol Sulphate BP 1mg + Guiaphenesin BP 4024 + 50mg + Menth 1mg 4025 Glimetab -2 Tablets Glimepiride USP 2mg POM Tablet Uncoated 310/003 MMC Healthcare Limited, India 4026 Glimetab -1 Tablets Glimepiride USP 1mg POM Tablet Uncoated 310/004 MMC Healthcare Limited, India Amlowin -10 Tablets Amlodipine Besylate USP POM Tablet Uncoated 310/005 MMC Healthcare Limited, India 4027 10mg Easoril -40 Capsules Esomeprazole POM Capsule oral 310/006 MMC Healthcare Limited, India 4028 Magnesium USP 40mg 4029 Moringa Miracle Capsules Moringa Oleifera 300mg P Capsule oral 352/001L Moringa Initialtive Limited, Zambia Atorem 10 Tablets Artovastatin Calcium POM Tablet Uncoated 311/001 MSN Laboratories Ltd, India 4030 10mg Atorem 20 Tablets Artovastatin Calcium POM Tablet Uncoated 311/002 MSN Laboratories Ltd, India 4031 20mg

Page 207 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER LDNIL 10 Tablets Rosuvastatin Calcium POM Tablet Uncoated 311/003 MSN Laboratories Ltd, India 4032 10mg LDNIL 20 Tablets Rosuvastatin Calcium POM Tablet Uncoated 311/004 MSN Laboratories Ltd, India 4033 20mg Breathezy CW 5 Tablets Montelukast Sodium 5mg POM Tablet Uncoated 311/005 MSN Laboratories Ltd, India 4034 4035 Plasep Tablets Clopidogrel 75mg POM Tablet Film coated 311/006 MSN Laboratories Ltd, India Esem 5 Tablets S-Amlodipine Besylate POM Tablet Uncoated 311/007 MSN Laboratories Ltd, India 4036 5mg Esem 2.5mg Tablets S-Amlodipine Besilate POM Tablet Uncoated 311/008 MSN Laboratories Ltd, India 4037 2.5mg Safelevo 750 Tablets Levofloxacin POM Tablet Film coated 311/009 MSN Laboratories Ltd, India 4038 Hemihydrate 750mg 4039 Safetelmi 40 Tablets Telmisartan 40mg POM Tablet Film Coated 311/010 MSN Laboratories Ltd, India 4040 Safetelmi 80 Tablets Telmisartan 80mg POM Tablet Film coated 311/011 MSN Laboratories Ltd, India 4041 Silmet 50 Tablets Sildenafil Citrate 50mg POM Tablet Uncoated 311/012 MSN Laboratories Ltd, India 4042 Silmet 100 Tablets Sildenafil Citrate 100mg POM Tablet Uncoated 311/013 MSN Laboratories Ltd, India Breatheay 4 Tablets Montelukast Sodium 4mg POM Tablet Uncoated 311/014 MSN Laboratories Ltd, India 4043 4044 Silotrif 8 Capsules Silodosin 8mg POM Capsule oral 311/015 MSN Laboratories Ltd, India 4045 Cosamide 50 Tablets Lacosamide I.H 50mg POM Tablet Uncoated 311/016 MSN Laboratories Ltd, India 4046 Cosamide 100 Tablets Lacosamide I.H 100mg POM Tablet Uncoated 311/017 MSN Laboratories Ltd, India 4047 Cosamide 150 Tablets Lacosamide I.H 150mg POM Tablet Uncoated 311/018 MSN Laboratories Ltd, India 4048 Cosamide 200 Tablets Lacosamide I.H 200mg POM Tablet Uncoated 311/019 MSN Laboratories Ltd, India Safelevo 500 Tablets Levofloxacin POM Tablet Uncoated 311/020 MSN Laboratories Ltd, India 4049 Hemihydrate 500mg 4050 Nebiem 2.5 Tablets Nebivolol 2.5mg POM Tablet Uncoated 311/021 MSN Laboratories Ltd, India 4051 Nebiem 5 Tablets Nebivolol 5mg POM Tablet Uncoated 311/022 MSN Laboratories Ltd, India 4052 Nebiem 10 Tablets Nebivolol 10mg POM Tablet Uncoated 311/023 MSN Laboratories Ltd, India 4053 Nebiem 20 Tablets Nebivolol 20mg POM Tablet Uncoated 311/024 MSN Laboratories Ltd, India Glimepiride 2mg + POM 311/025 ILET B2 Extended Release Caplet Sustained Metformin Hydrochloride MSN Laboratories Ltd, India Tablets Release 4054 500mg Glimepiride 1mg + POM 311/026 ILET B1 Extended Release Tablet Extended Metformin Hydrochloride MSN Laboratories Ltd, India Tablets Release 4055 500mg POM Tablet sustained 311/027 Febuday 80 Tablets Febuxostat 80mg MSN Laboratories Ltd, India 4056 release 4057 Febuday 40 Tablets Febuxostat 40mg POM Tablet Uncoated 311/028 MSN Laboratories Ltd, India

Page 208 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 4058 Breatheazy 10 Tablets Montelukast 10mg POM Tablet Uncoated 311/029 MSN Laboratories Ltd, India Ramgic 50 Injection Tramadol hydrochloride POM Solution for 311/031 MSN Laboratories Ltd, India 4059 50mg Injection Lopinavir and Ritonivir Tablets Ritonavir 200mg + POM Tablet Uncoated 014/001 Mylan Laboratories Ltd, India 4060 Lopinavir 50mg Tenofivir Disoproxil Fumurate / Tenofovir 300mg + POM Tablet Uncoated 014/002 Mylan Laboratories Ltd, India 4061 Lamivudine Tablets Lamivudine 300mg Tenofovir Disoproxil Fumurate Tenofovir 300mg POM Tablet Uncoated 014/003 Mylan Laboratories Ltd, India 4062 Tablets 4063 Abacavir Sulphate Tablets Abacavir 300mg POM Tablet Uncoated 014/004 Mylan Laboratories Ltd, India Tenofovir Disoproxil Fumurate + Tenofovir 300mg + POM Tablet Uncoated 014/005 Mylan Laboratories Ltd, India 4064 Emtricitabine Tablets Emtricitabine 200mg 4065 Lamivudine Tablets Lamivudine 150mg POM Tablet Uncoated 014/006 Mylan Laboratories Ltd, India 4066 Efavirenz Tablets Efavirenz 600mg POM Tablet Uncoated 014/007 Mylan Laboratories Ltd, India Lamivudine + Nevirapine + Lamivudine 150mg + POM Tablet Uncoated 014/019 Mylan Laboratories Ltd, India Zidovudine Tablets Nevirapine 200mg + 4067 Zidovudine 300mg Lamivudine + Zidovudine Lamivudine 150mg + POM Tablet Uncoated 014/021 Mylan Laboratories Ltd, India 4068 Tablets Zidovudine 300mg 4069 Nevirapine 200mg Tablets Nevirapine 200mg POM Tablet Uncoated 014/022 Mylan Laboratories Ltd, India 4070 Nevirapine 300mg Tablets Nevirapine 300mg POM Tablet Uncoated 014/023 Mylan Laboratories Ltd, India Tenofovir disoproxil fumerate/ Tenofovir Disoproxil POM Tablet Uncoated 014/024 Mylan Laboratories Ltd, India Efavirenz/ Emitricitabine FDC Fumarate 300mg + Tablets Emtricitabine 200mg + 4071 Efavirenz 600mg Abacavir sulphate/ Lamivudine/ Abacavir 60mg + POM Tablet Film coated 014/025 Mylan Laboratories Ltd, India Zidovudine Tablets Lamivudine 30mg + 4072 Zidovudine 60mg 4073 Abacavir Tablets Abacavir 60mg POM Tablet Film coated 014/026 Mylan Laboratories Ltd, India Lamivudine/ Zidovudine Tablets Lamivudine 30mg+ POM Tablet Film coated 014/027 Mylan Laboratories Ltd, India 4074 Zidovudine 60mg Lopinavir/ Ritonavir Tablets Lopinavir 100 + Ritonavir POM Tablet Film coated 014/028 Mylan Laboratories Ltd, India 4075 25mg Lamivudine/ Nevirapine/ Lamivudine 30mg + POM Tablet Uncoated 014/029 Mylan Laboratories Ltd, India Zidovudine Tablets Nevirapine 50mg + 4076 Zidovudine 60mg

Page 209 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Tenofovir disoproxil fumarate/ Tenofovir Disproxil POM Tablet Uncoated 014/030 Mylan Laboratories Ltd, India Lamivudine/ Efavirenz Tablets Fumarate 300mg + Lamivudine 300mg + 4077 Efavirenz 600mg 4078 Efavirenz Tablets Efavirenz 100mg POM Tablet Film coated 014/031 Mylan Laboratories Ltd, India 4079 Efavirenz Tablets Efavirenz 200mg POM Tablet Film coated 014/032 Mylan Laboratories Ltd, India Abacavir Sulphate/Lamivudine Abacavir 60mg + POM Tablet Film coated 014/033 Mylan Laboratories Ltd, India 4080 Tablets Lamivudine 30mg 4081 Ritonivir Tablets Ritonavir 100mg POM Tablet Film coated 014/034 Mylan Laboratories Ltd, India 4082 Atazanavir Sulphate Tablets Atazanavir 300mg POM Capsule oral 014/035 Mylan Laboratories Ltd, India Anzavir-R Tablets Atazanavir 300mg + POM Tablet Film coated 014/036 Mylan Laboratories Ltd, India 4083 Ritonivir 100mg Oseltamivir Phosphate Oseltamivir 30mg POM Capsule oral 014/037 Mylan Laboratories Ltd, India 4084 Capsules USP Oseltamivir Phosphate Oseltamivir 45mg POM Capsule oral 014/038 Mylan Laboratories Ltd, India 4085 Capsules USP Oseltamivir Phosphate Oseltamivir 75mg POM Capsule oral 014/039 Mylan Laboratories Ltd, India 4086 Capsules USP Komefan 280 Tablet Artemether 40mg + POM Tablet Uncoated 014/040 Mylan Laboratories Ltd, India 4087 Lumefantrine 240mg Komefan 140 Tablet Artemether 20mg + POM Tablet Uncoated 014/041 Mylan Laboratories Ltd, India 4088 Lumefantrine 120mg Lamivudine 30 + Zidovudine 60 Lamivudine 30mg + POM Tablet Film coated 014/042 Mylan Laboratories Ltd, India 4089 Tablets Zidovudine 60mg Kefloxa 500 Tablets Cefuroxime Axetil USP POM Tablet Film coated 014/043 Mylan Laboratories Ltd, India 4090 500mg Kefloxa 250 Tablets Cefuroxime Axetil USP POM Tablet Film coated 014/044 Mylan Laboratories Ltd, India 4091 250mg Te4lkast 4 Tablets Montelukast Sodium BP POM Tablet Uncoated 014/045 Mylan Laboratories Ltd, India 4092 4mg Te4lkast 5 Tablets Montelukast Sodium BP POM Tablet Uncoated 014/046 Mylan Laboratories Ltd, India 4093 5mg Telkast 10 Tablets Montelukast Sodium BP POM Tablet Uncoated 014/047 Mylan Laboratories Ltd, India 4094 10mg 4095 Zomacid 20 Omeprazole 20mg POM Capsule oral 014/052 Mylan Laboratories Ltd, India 4096 Zomacid 40 Capsules Omeprazole 40mg POM Capsule oral 014/053 Mylan Laboratories Ltd, India Hertraz 150 Infusion Trastuzumab 150mg POM Solution for 014/054 Mylan Laboratories Ltd, India 4097 infusion

Page 210 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Hertraz 440 Infusion Trastuzumab 440mg POM Solution for 014/055 Mylan Laboratories Ltd, India 4098 infusion Vancomycin Hydrochloride 500 Vancomycin POM Solution for 014/056 Mylan Laboratories Ltd, India 4099 Injection Hydrochloride 500mg Injection Avonza Tablets Tenofovir Disoproxil POM Tablet Film coated 014/057 Mylan Laboratories Ltd, India Fumarate 300mg + Lamivudine 300mg + 4100 Efavirenz 400mg Vaclovir 500 Film Coated Valacyclovir 500mg POM Tablet Uncoated 014/058 Mylan Laboratories Ltd, India 4101 Tablets POM Tablet Film coated 014/059 Mylan Laboratories Ltd, India 4102 Protionamide Tablets 250mg Protionamide 250mg Carboplatin Mylan Injection Carboplatin 10mg, per POM Solution for 014/060 Mylan Laboratories Ltd, India 4103 ml, 45ml Injection Carboplatin Mylan Injection Carboplatin 10mg, per POM Solution for 014/061 Mylan Laboratories Ltd, India 4104 ml, 15ml Injection Azithromycin Injection Azithromycin Prescription Only Powder for 406/001 Mylan Laboratories Ltd, India Monohydrate USP Medicine Injection 4105 500mg 4106 Mydekla 60 Tablets Daclatasvir 60mg POM Tablet Film coated 014/061 Mylan Laboratories Ltd, India 4107 Mydekla 30 Tablets Daclatasvir 30mg POM Tablet Film coated 014/062 Mylan Laboratories Ltd, India Myzomib Injection Bortezomib 3.5mg POM Solution for 014/063 Mylan Laboratories Ltd, India 4108 Injection 4109 Glandin E2 Vaginal Gel Dinoprostone 2mg POM Gel Vaginal 070/001 Nabiqasim Industries Ltd, Pakistan 4110 Glandin E2 Vaginal Tablets Dinoprostone 2mg POM Tablet Vaginal 070/002 Nabiqasim Industries Ltd, Pakistan Kleen Enama Sodium Biphosphate POM Solution for 070/003 Nabiqasim Industries Ltd, Pakistan 19.2g + Sodium infusion 4111 Phosphate 7.2g Colospas Fibro Sachets Mebeverine GS Granules for Oral 070/004 Nabiqasim Industries Ltd, Pakistan Hydrochloride 135mg + Use 4112 Ispaghula Husks 3.5mg Detoxicol Syrup Lactulose + Lactose + P Syrup 070/005 Nabiqasim Industries Ltd, Pakistan 4113 Galactose Irpo FA Tablets Hydroxide Polymaltose P Tablet Uncoated 070/006 Nabiqasim Industries Ltd, Pakistan Complex 0.35mg + Folic 4114 Acid 0.403mg Acefyl Cough Syrup Acefilline Pipetazine P Syrup 070/007 Nabiqasim Industries Ltd, Pakistan 45mg + 4115 Diphenhydramine 8mg

Page 211 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Irpo FA Syrup Hydroxide Polymaltose P Syrup 070/008 Nabiqasim Industries Ltd, Pakistan Complex 50mg + Folic 4116 Acid 0.35mg Clarithro Tablets Clarithromycin USP POM Tablet Film coated 070/009 Nabiqasim Industries Ltd, Pakistan 4117 500mg 4118 Capro 6.25 Tablets Carvedilol BP 6.25mg POM Tablet Uncoated 070/010 Nabiqasim Industries Ltd, Pakistan 4119 Capro 25mg Tablets Carvedilol BP 25mg POM Tablets oral 070/011 Nabiqasim Industries Ltd, Pakistan 4120 Capro 12.5 Tablets Carvedilol BP 12.5mg POM Tablet Uncoated 070/012 Nabiqasim Industries Ltd, Pakistan Zynq Syrup Zinc Sulphate 20mg, per GSL Solution for Oral 070/013 Nabiqasim Industries Ltd, Pakistan 4121 5ml Use Multical plus Sachets 10's Calcium Pantothenate BP P Powder for Oral 070/014L Nabiqasim Industries Ltd, Pakistan 4122 15mg Solution Multical 1000 Sachets 10's Calcium Lactate P Powder for Oral 070/015L Nabiqasim Industries Ltd, Pakistan 4123 Gluconate BP 1000mg Suspension 4124 Cefabact 500 Capsules 20's Cefacroxil 500mg USP POM Capsule oral 070/016 Nabiqasim Industries Ltd, Pakistan Cefabact 125 /5ml Syrup 60ml Cefadroxil 125mg, per POM Suspension for 070/017 Nabiqasim Industries Ltd, Pakistan 4125 5ml Oral Use Ciprodex Tablets Ciprofloxacin POM Tablet Film coated 210/001 Nabros Pharma Limited, India 4126 Hydrochloride 500mg 4127 Nifedipine Capsules Nifedipine 20mg POM Capsule oral 210/002 Nabros Pharma Limited, India Flucoldex Tablets Chlorpheniramine P Tablet Uncoated 210/003 Nabros Pharma Limited, India Maleate 2mg + Phenylephrine HCl 5mg + 4128 Paracetamol 500mg Carboplatin Injection Carboplatin 150mg, per POM Solution for 086/001MT Naprod Life Sciences Pvt Limited, India 4129 15ml Injection Daunorubicin Hcl Injection Daunorubicin 20mg POM Solution for 086/002MT Naprod Life Sciences Pvt Limited, India 4130 Injection Doxorubicin Hcl Injection Doxorubicin 50mg POM Powder for 086/003MT Naprod Life Sciences Pvt Limited, India 4131 Injection Etoposide Injection Etoposide 100mg, per POM Powder for 086/004MT Naprod Life Sciences Pvt Limited, India 4132 5ml Injection Ifosfamide for Injection Ifosfamide 1g POM Powder for 086/005MT Naprod Life Sciences Pvt Limited, India 4133 Injection Leucovorin Calcium Injection Leucovorin 50mg, per POM Solution for 086/006MT Naprod Life Sciences Pvt Limited, India 4134 5ml Injection Vinorelbine Injection Vinorelbine 5mg, per 5ml POM Solution for 086/007 Naprod Life Sciences Pvt Limited, India 4135 Injection

Page 212 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Dactinomycin for Injection Dactinomycin 0.5mg POM Solution for 086/008MT Naprod Life Sciences Pvt Limited, India 4136 Injection Capacetabine USP 500mg POM Tablet Film coated 086/009MT Naprod Life Sciences Pvt Limited, India Capacetabine 500mg 4137 Tablets POM Powder for 086/010MT Naprod Life Sciences Pvt Limited, India Fluouracil BP Injection Fluorouracil 500mg 4138 Injection POM Solution for 086/011MT Naprod Life Sciences Pvt Limited, India Cisplatin BP 50mg/5ml Cisplatin 50mg, per 5ml 4139 Injection POM Solution for 086/012MT Naprod Life Sciences Pvt Limited, India Dacarbazine for Injection USP Dacarbazine 200mg 4140 Injection Bleomycin for Injection USP POM Powder for 086/013 Naprod Life Sciences Pvt Limited, India Bleomycin 15Units 4141 15Units Injection POM Powder for 306/001 Nectar Lifesciences Limited Necpime- 1G Injection Cefepime 1g 4142 Injection POM Powder for 306/002 Nectar Lifesciences Limited Nectram- 1G Injection Ceftriaxone 1g 4143 Injection Cefuroxime Axetil USP POM Powder for Oral 306/003 Nectar Lifesciences Limited Cefuaxit Dry Syrup 4144 125mg, per 5ml Suspension Cefuroxime Axetil USP POM Tablet Uncoated 306/004 Nectar Lifesciences Limited Cefuaxit 250 Tablets 4145 250mg Cefixime Trihydrate USP POM Tablet Uncoated 306/005 Nectar Lifesciences Limited Fixinect 200 Tablets Eq Anhydrous Cefixime 4146 200mg Amphotericin B USP POM Solution for 182/001 Neon Antibiotics Pvt Ltd, India Mycol Injection 4147 50mg Injection Dextrose 42.22%w/w + GS Powder for Oral 344/001L New Image International Ltd, New zealand Skim Milk Powder Solution Alpha Lipid Lifeline Powder 25.59%w/w + Calcium Phosphate 10.5%w/w + 4148 Colostrum Powder 4149 Fluconazole Capsules Fluconazole 200mg POM Jar 226/001 Nibin Pharmaceuticals Ltd, India POM Solution for 103/001 Nicholas Piramal India Limited Sterile Polygeline Solution Polygeline 25g 4150 infusion POM Solution for 103/002 Nicholas Piramal India Limited Halothane Calibrated Solution Halothane 250mg 4151 Inhalation Metronidazole 500mg, POM Solution for 103/003 Nicholas Piramal India Limited Metronidazole Injection 4152 per 100ml Injection Ciprofloxacin 200mg, per POM Solution for 103/004 Nicholas Piramal India Limited Ciprofloxacin Injection 4153 100ml Injection

Page 213 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER POM Solution for 036/001 Nirlife Healthcare (Former Core Healthcare Glucose IV Infusion 500ml Dextrose 5% 4154 infusion Ltd), India POM Solution for 036/002 Nirlife Healthcare (Former Core Healthcare Glucose IV Infusion 1000ml Dextrose 5% 4155 infusion Ltd), India POM Solution for 036/003 Nirlife Healthcare (Former Core Healthcare Glucose IV Infusion 10D 1000ml Dextrose 10% 4156 infusion Ltd), India POM Solution for 036/004 Nirlife Healthcare (Former Core Healthcare Glucose IV Infusion 10D 500ml Dextrose 10% 4157 infusion Ltd), India Sodium Chloride & Glucose Dextrose 5% + Sodium POM Solution for 036/005 Nirlife Healthcare (Former Core Healthcare 4158 DNS 500ml Chloride 0.9% infusion Ltd), India Sodium Chloride & Glucose Dextrose 5% + Sodium POM Solution for 036/006 Nirlife Healthcare (Former Core Healthcare 4159 DNS 1000ml Chloride 0.9% infusion Ltd), India POM Solution for 036/007 Nirlife Healthcare (Former Core Healthcare Sodium Chloride Infusion 500ml Sodium Chloride 0.9% 4160 infusion Ltd), India Sodium Chloride Infusion POM Solution for 036/008 Nirlife Healthcare (Former Core Healthcare Sodium Chloride 0.9% 4161 1000ml infusion Ltd), India POM Solution for 036/009 Nirlife Healthcare (Former Core Healthcare Ciprofloxacin Injection Ciprofloxacin 0.2% 4162 infusion Ltd), India POM Solution for 036/010 Nirlife Healthcare (Former Core Healthcare Water For Injection 5ml Water For Inj. USP 4163 infusion Ltd), India POM Solution for 036/011 Nirlife Healthcare (Former Core Healthcare Water For Injection 10ml Water For Inj. USP 4164 infusion Ltd), India POM Solution for 036/012 Nirlife Healthcare (Former Core Healthcare Mannitol IV Infusion 100ml Mannitol 20% 4165 infusion Ltd), India POM Solution for 036/013 Nirlife Healthcare (Former Core Healthcare Mannitol IV Infusion 250ml Mannitol 20% 4166 Injection Ltd), India Sodium Chloride 6.0g, POM Solution for 036/014 Nirlife Healthcare (Former Core Healthcare per L+ Sodium Lactate Injection Ltd), India Compound Sodium Lactate 3.20g, per L + Potassium 500ml Chloride 0.40g, per L + Calcium Chloride 0.27g, 4167 per L Sodium Chloride 6.0g, POM Solution for 036/015 Nirlife Healthcare (Former Core Healthcare per L + Sodium Lactate Injection Ltd), India Compound Sodium Lactate 3.20g, per L+ Potassium 1000ml Chloride 0.4g, per L + Calcium Chloride 0.27g, 4168 per L

Page 214 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER POM Solution for 036/016 Nirlife Healthcare (Former Core Healthcare Metronidazole Injection Metronidazole 200mg 4169 Injection Ltd), India Benzyl Penicillin 5Mega POM Powder for 033/001 North China Pharmaceutical Group Benzylpenicillin Injection 5MU 4170 I.U. Injection International Corporation, Benzyl Penicillin 1Mega POM Powder for 033/002 North China Pharmaceutical Group Benzylpenicillin Injection 1MU 4171 I.U Injection International Corporation, Amoxicillin Trihydrate POM Capsule oral 033/003 North China Pharmaceutical Group Amoxicillin Capsules 4172 250mg International Corporation, GS Tablet Uncoated 033/004 North China Pharmaceutical Group Paracetamol Tablets Paracetamol 500mg 4173 International Corporation, Sulphamethoxazole POM Tablet Uncoated 033/005 North China Pharmaceutical Group Co-trimoxazole Tablets 400mg + Trimethoprim International Corporation, 4174 80mg POM Tablet Uncoated 033/006 North China Pharmaceutical Group Prednisolone Tablets Prednisolone 5mg 4175 International Corporation, POM Tablet Uncoated 033/007 North China Pharmaceutical Group Captotril Tablets Captopril 25mg 4176 International Corporation, Carbocisteine 250mg, per POM Syrup 033/008 North China Pharmaceutical Group Carbocisteine Syrup 4177 5ml International Corporation, Carbocisteine 100mg, per POM Syrup 033/009 North China Pharmaceutical Group NCPC Carbocisterine Syrup 4178 5ml International Corporation, Calciumgluconate 100mg P Tablet Uncoated 033/010 North China Pharmaceutical Group + Calcium 60mg + International Corporation, Multi-Cal-Vita Hydrogen 20mg Phosphate 100mg+ 4179 Calcium Glycero 30mg P Tablet Uncoated 033/011 North China Pharmaceutical Group Ibuprofen Tablets Ibuprofen 200mg 4180 International Corporation, POM Powder for 033/012 North China Pharmaceutical Group Ceftriaxone Injection Ceftriaxone 1g 4181 Injection International Corporation, P Tablet Uncoated 033/013 North China Pharmaceutical Group Diclofenac Tablets Diclofenac 50mg 4182 International Corporation, POM Solution for 033/014 North China Pharmaceutical Group Diclofenac Injection Diclofenac 75mg, per 3ml 4183 Injection International Corporation, POM Powder for 033/015 North China Pharmaceutical Group Streptomycin Injection Streptomycin 1g 4184 Injection International Corporation, POM Capsule oral 033/016 North China Pharmaceutical Group Tetracycline Capsules Tetracycline 250mg 4185 International Corporation,

Page 215 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER GS Tablet Uncoated 033/017 North China Pharmaceutical Group Vitamin C Tablets Ascorbic Acid 250mg 4186 International Corporation, Gentamicin 80mg, per POM Solution for 033/018 North China Pharmaceutical Group Gentamicin Injection 4187 2ml Injection International Corporation, P Tablet Uncoated 033/019 North China Pharmaceutical Group Chlorpheniramine Tablets Chlorpheniramine 4mg 4188 International Corporation, POM Tablet Uncoated 033/020 North China Pharmaceutical Group Metronidazole Tablets Metronidazole 250mg 4189 International Corporation, Paracetamol 200mg + P Capsule oral 033/021 North China Pharmaceutical Group Ibupamol Capsules 4190 Ibuprofen 325mg International Corporation, POM Powder for Oral 033/022 North China Pharmaceutical Group Cefalexin For Oral Suspension Cefalexin 125mg, per 5ml 4191 Suspension International Corporation, POM Capsule oral 033/023 North China Pharmaceutical Group Cephalexin BP 500mg Capsules Cephalexin 500mg 4192 International Corporation, Cefuroxime Axetil For Oral Cefuroxime 125mg, per POM Powder for Oral 033/024 North China Pharmaceutical Group 4193 Suspension 5ml Suspension International Corporation, Cefuroxime Axetil 250mg POM Tablet Uncoated 033/025 North China Pharmaceutical Group Cefuroxime 250mg 4194 Tablets International Corporation, Benzathine Benzlypenicillin For Benzathine POM Powder for 033/026 North China Pharmaceutical Group 4195 Injection Benzlypenicillin 2.4Mega Injection International Corporation, Aminophylline 250mg, POM Solution for 033/027 North China Pharmaceutical Group Aminophylline 250mg Injection 4196 per 10ml Injection International Corporation, POM Solution for 033/029 North China Pharmaceutical Group Fluconazole Injection Fluconazole 2mg, per ml 4197 Injection International Corporation, POM Tablet Uncoated 033/030 North China Pharmaceutical Group Salbutamol Tablets Sabultamol 2mg 4198 International Corporation, POM Capsule oral 033/031 North China Pharmaceutical Group Chloramphenicol Capsules Chloramphehicol 250mg 4199 International Corporation, Furosemide 20mg, per POM Solution for 033/032 North China Pharmaceutical Group Furosemide Injection BP 4200 2ml Injection International Corporation, Cefotaxime Sodium BP 1gram POM Powder for 033/033 North China Pharmaceutical Group Cefotaxime 1gram 4201 Injection Injection International Corporation, Hyocine Butylbromide 20mg BP Hyocine Butylbromide POM Solution for 033/034 North China Pharmaceutical Group 4202 Injection 20mg Injection International Corporation, Kanamycin Sulphate Injection POM Powder for 033/035 North China Pharmaceutical Group Kanamycin 1.0g 4203 BP Injection International Corporation, Carbamezapine Tablets 200mg POM Tablet Uncoated 033/036 North China Pharmaceutical Group Carbamezapine 200mg 4204 BP International Corporation,

Page 216 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER POM Tablet Uncoated 033/037 North China Pharmaceutical Group Trihexyphenidyl Tablets BP 5mg Trihexyphenidyl 5mg 4205 International Corporation, POM Tablet Uncoated 033/038 North China Pharmaceutical Group Methyldopa Tablets BP 250mg Methyldopa 250mg 4206 International Corporation, Sterile Water for Injection BP Sterile Water for POM Solution for 033/039 North China Pharmaceutical Group 4207 10mls Injections infusion International Corporation, POM Solution for 033/040 North China Pharmaceutical Group Vitamin B Complex Injection Vitamin B 4208 Injection International Corporation, POM Tablet Uncoated 033/041 North China Pharmaceutical Group Aciclovir Tablets Aciclovir 400mg 4209 International Corporation, Hydrocortisone Sodium POM Powder for 033/042 North China Pharmaceutical Group Hydrocortisone 100mg 4210 Succinate for Injection Injection International Corporation, Magnesium Sulphate POM Solution for 033/043 North China Pharmaceutical Group Magnesium Sulphate Injection 4211 500mg, per ml Injection International Corporation, Amoxicilin Trihydrate POM Suspension for 033/044 North China Pharmaceutical Group Amoxicillin Oral Suspension 4212 125mg, per 5ml Oral Use International Corporation, Chloramphenical Powder for Chloramphenicol POM Powder for Oral 033/045 North China Pharmaceutical Group 4213 Oral Suspension Palmitate 125mg/5ml Suspension International Corporation, Phenoxymethyl Penicillin POM Powder for Oral 033/046 North China Pharmaceutical Group Phenoxymethylpenicillin Powder Potassium 125mg, per Suspension International Corporation, For Oral Suspension 125mg/5ml 4214 5ml POM Tablet Uncoated 033/047 North China Pharmaceutical Group Aminophylline Tablets Aminophylline 100mg 4215 International Corporation, P Tablet Uncoated 033/048 North China Pharmaceutical Group Aspirin Tablets Aspirin 300mg 4216 International Corporation, Ciprofloxacin POM Tablet Uncoated 033/049 North China Pharmaceutical Group Ciprofloxacin Tablets 4217 Hydrochloride 500mg International Corporation, Pyridoxine Hydrochloride POM Tablet Uncoated 033/050 North China Pharmaceutical Group Pyridoxine Tablets 4218 50mg International Corporation, Phenoxymethyl Penicillin POM Tablet Uncoated 033/051 North China Pharmaceutical Group Phenoxymethylpenicillin Tablets 4219 Potassium 250mg International Corporation, POM Tablet Uncoated 033/052 North China Pharmaceutical Group Ranitidine tablets Ranitidine 150mg 4220 International Corporation, POM Solution for 033/053 North China Pharmaceutical Group Water for injection Water for Injection 4221 Injection International Corporation, Fortified Procaine Penicillin POM Powder for 033/054 North China Pharmaceutical Group Procaine Penicillin 4MU 4222 injection Injection International Corporation,

Page 217 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Sulfamethoxazole 200mg POM Suspension for 033/055 North China Pharmaceutical Group Co-trimoxazole Oral Suspension + Trimethoprim 40mg , Oral Use International Corporation, 4223 per 5ml Vitamin B1+ Vitamin B2 + P Tablet Uncoated 033/056 North China Pharmaceutical Group Vitamin B6 + International Corporation, Nicotinamide 5 + Calcium Vitamin B Complex Tablets D-Pantothenate BP + Vitamin B 12 + Folic Acid 4224 BP POM Solution for 033/057 North China Pharmaceutical Group Oxytocin 10IU Injection Oxytocin 10 IU 4225 Injection International Corporation, POM Eye Drops 033/058 North China Pharmaceutical Group Chloramphenicol Eye Drops Chloramphehicol 1% 4226 International Corporation, POM Capsule oral 033/059 North China Pharmaceutical Group Cloxacillin Capsules Cloxacillin 250mg 4227 International Corporation, Diclofenac Sodium P Tablet Uncoated 033/060 North China Pharmaceutical Group Diclofenac Tablets 4228 100mg International Corporation, P Capsule oral 033/061 North China Pharmaceutical Group Indomethacin Capsule Indomethacin 25mg 4229 International Corporation, Nystatin 100,000IU, per POM Suspension for 033/062 North China Pharmaceutical Group Nystatin Oral Suspension 4230 ml Oral Use International Corporation, P Capsule oral 033/063 North China Pharmaceutical Group Piroxicam Capsules Piroxicam 20mg 4231 International Corporation, Triprolidine 1.25mg+ P Syrup 025/002 Norvatis Consumer Health International, Actifed Expectorant Syrup Pseudoephedrine 30mg Switzerland 4232 + Guaiphenesin 100mg Paracetamol + P Tablet Uncoated 025/005 Norvatis Consumer Health International, Antigesic Tablets Propylptenazone + Switzerland 4233 Caffeine Tripolidine + P Syrup 025/015 Norvatis Consumer Health International, Linctifed Expectorant Forte Pseudoephedrine + Switzerland Syrup 4234 Guaiphenisin + Codeine Paracetamol 120mg, per GS Suspension for 025/018 Norvatis Consumer Health International, Calpol Suspension 4235 5ml Oral Use Switzerland Pseudoephedrine 30mg, P Syrup 025/031 Norvatis Consumer Health International, Sudafed Syrup 4236 per 5ml Switzerland Triprolidine + P Tablet Uncoated 025/033 Norvatis Consumer Health International, Sudagesic Tablets Pseudoephedrine + Switzerland 4237 Paracetamol

Page 218 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER POM Tablet Film coated 121/041 Norvatis Consumer Health International, Galvus Met 50 Tablets Vildagliptin 50mg 4238 Switzerland Artemether 80mg + POM Tablet Uncoated 121/047 Norvatis Consumer Health International, Coartem 80/480 Tablet 4239 Lumefantrine 480mg Switzerland P Gel Topical 242/001 Norvatis Consumer Health International, Otrivin Gel Xylometazoline 1%w/w 4240 Switzerland Dimethendene 1mg, per P Syrup 242/002 Norvatis Consumer Health International, Fenistil Drops 4241 ml Switzerland Ferrous Sulphate 160mg P Tablet Film coated 242/005 Norvatis Consumer Health International, Slow Iron & Folic Acid Tablets 4242 + Folic Acid 0.4mg Switzerland Rosemary Oil 5% + P Ointment topical 242/007 Norvatis Consumer Health International, Eucalyptus Oil 5% + Switzerland Pulmex Baby Ointment Synthetic Perivian 4243 Balisam 6% POM Solution for 242/009 Norvatis Consumer Health International, Travegyl Ampoules Clemastine 1.0mg, per ml 4244 Injection Switzerland POM Syrup 242/010 Norvatis Consumer Health International, Travegyl Syrup Clemastine 0.1mg, per ml 4245 Switzerland POM Syrup 242/011 Norvatis Consumer Health International, Travegyl 1mg Syrup Clemastine 1mg 4246 Switzerland P Gel Topical 242/015 Norvatis Consumer Health International, Voltaren Emulgel Diclofenac 1% 4247 Switzerland P Tablet Uncoated 242/016 Norvatis Consumer Health International, Calcium Sandoz Tablets Calcium 500mg 4248 Switzerland Calcium Sandoz + Vitamin C Calcium 260mg + P Tablet Uncoated 242/017 Norvatis Consumer Health International, 4249 Tablets Ascorbic Acid 1000mg Switzerland Valsartan 160mg + POM Tablet Film coated 242/018 Norvatis Consumer Health International, Co-Diovan Tablets Hydrochlorothiazide Switzerland 4250 25mg Galvus Met 50/500 Tablets Vildagliptin 50mg + POM Tablet Film coated 242/021 Norvatis Consumer Health International, Metformin Ph. Eur. Switzerland 4251 500mg Galvus Met 50/500 Tablets Vildagliptin 50mg + POM Tablet Film coated 242/022 Norvatis Consumer Health International, Metformin Ph. Eur. Switzerland 4252 850mg Galvus Met 50/1000 Tablets Vildagliptin 50mg + POM Tablet Film coated 242/023 Norvatis Consumer Health International, Metformin Ph. Eur. Switzerland 4253 1000mg 4254 Voltaren 75mg Tablets Diclofenac 75mg p Tablet Uncoated 0359/05 Novartis Pharma Services Inc, Kenya

Page 219 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Valsartan 160mg + POM Tablet Film coated 120/041 Novartis Pharma Services Inc, Kenya Exforge Tablets 4255 Amlodpine 5mg Valsartan 80mg + POM Tablet Film coated 120/042 Novartis Pharma Services Inc, Kenya Exforge Tablets 4256 Amlodipine 5mg Valsartan 160mg + POM Tablet Film coated 120/043 Novartis Pharma Services Inc, Kenya Exforge Tablets 4257 Amlodipine 10mg POM Tablet Film coated 120/045 Novartis Pharma Services Inc, Kenya Sebivo Tablets Telbivudine 600mg 4258 4259 Sirdakud Tablets Tizinidine 4mg POM Tablet Uncoated 120/046 Novartis Pharma Services Inc, Kenya Artemether 20mg + POM Tablet Uncoated 121/001 Novartis Pharma Services Inc, Kenya Coartem Tablets 4260 Lumefantrine 120mg 4261 Voltaren D 50mg Tablets Diclofenac 50mg P Tablet Uncoated 121/002 Novartis Pharma Services Inc, Kenya 4262 Cataflam Drops Diclofenac 15mg, per ml P Oral drops 121/003 Novartis Pharma Services Inc, Kenya 4263 Elidel Cream Pimecrolimus 1%w/w POM Cream Topical 121/004 Novartis Pharma Services Inc, Kenya 4264 Voltaren SR 75mg Tablets Diclofenac 75mg P Tablet Uncoated 121/005 Novartis Pharma Services Inc, Kenya 4265 Lescol XL Tablets Fluvastatin 80mg POM Tablet Uncoated 121/006 Novartis Pharma Services Inc, Kenya Hydrochlorothiazide POM Tablet Uncoated 121/007 Novartis Pharma Services Inc, Kenya Co-Diovan 80/12.5mg Tablets 12.5mg + Valsartan 4266 80mg 4267 Cataflam 50mg Tablets Diclofenac 50mg P Tablet Film coated 121/008 Novartis Pharma Services Inc, Kenya 4268 Lamisil Tablets Terbinafine 250mg POM Tablet Uncoated 121/009 Novartis Pharma Services Inc, Kenya 4269 Tegretol Syrup Carbamazepine 2%w/w POM Syrup 121/010 Novartis Pharma Services Inc, Kenya 4270 Tofranil Tablets Imipramine 25mg POM Tablet Uncoated 121/011 Novartis Pharma Services Inc, Kenya 4271 Voltaren 50 Suppositories Diclofenac 50mg P Suppository 121/012 Novartis Pharma Services Inc, Kenya 4272 Voltaren 100 Suppositories Diclofenac 100mg P Suppository 121/013 Novartis Pharma Services Inc, Kenya POM Solution for 121/014 Novartis Pharma Services Inc, Kenya Voltaren Injection Diclofenac 75mg, per 3ml 4273 Injection 4274 Anafranil Tablets Clomipramine 25mg POM Tablet Uncoated 121/015 Novartis Pharma Services Inc, Kenya 4275 Diovan 80mg Tablets Valsartan 80mg POM Tablet Uncoated 121/016 Novartis Pharma Services Inc, Kenya 4276 Diovan 160mg Tablets Valsartan 160mg POM Tablet Uncoated 121/017 Novartis Pharma Services Inc, Kenya Hydrochlorothiazide POM Tablet Uncoated 121/018 Novartis Pharma Services Inc, Kenya Co-Diovan 160/12.5mg Tablets 12.5mg + Valsartan 4277 160mg 4278 Voltfast 50mg Tablets Diclofenac 50mg P Tablet Uncoated 121/019 Novartis Pharma Services Inc, Kenya 4279 Voltaren 12.5 Suppositories Diclofenac 12.5mg P Suppository 121/020 Novartis Pharma Services Inc, Kenya 4280 Tegretol CR Tablets Carbamazepine 400mg POM Tablet Uncoated 121/021 Novartis Pharma Services Inc, Kenya 4281 Tegretol Tablets Carbamazepine 200mg POM Tablet Uncoated 121/022 Novartis Pharma Services Inc, Kenya Potassium Chloride POM Tablet Film coated 121/023 Novartis Pharma Services Inc, Kenya Slow K Tablets 4282 600mg

Page 220 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Sandomigran Coated Tablet POM Tablet film coated 121/025 Novartis Pharma Services Inc, Kenya Pizotifen Malate 0.5mg 4283 0.5mg Pindolol 10 Mg + POM Tablet uncoated 121/026 Novartis Pharma Services Inc, Kenya Viskaldix Tablet 5/10mg 4284 Clopamide 5mg Ketotifen Hydrogen POM Tablet uncoated 121/028 Novartis Pharma Services Inc, Kenya Zaditen Tablet 1mg 4285 Fumarate 1mg Ketotifen Hydrogen POM Syrup 121/029 Novartis Pharma Services Inc, Kenya Zaditen Syrup 1mg/5ml 4286 Fumarate 1 Mg, per 5ml Syntocinon Solution For POM Solution for 121/031 Novartis Pharma Services Inc, Kenya Oxtocin 5IU 4287 Injection 5IU/ml Injection 4288 Parlodel Tablet 2.5mg Bromocriptine 2.5mg POM Tablet uncoated 121/032 Novartis Pharma Services Inc, Kenya Syntocinon Solution For POM Solution for 121/035 Novartis Pharma Services Inc, Kenya Oxtocin 10IU 4289 Injection 10IU/ml Injection Artemether 20mg + POM Tablet Dispersible 121/036 Novartis Pharma Services Inc, Kenya Coartem Dispersible Tablets 4290 Lumefantrine 120mg Hydrochlorothiazide POM Tablet Uncoated 121/037 Novartis Pharma Services Inc, Kenya Co-Diovan 320/12.5mg Tablets 12.5mg + Valsartan 4291 320mg 4292 Rasilez 150mg Tablets Aliskren 150mg POM Tablet Film coated 121/038 Novartis Pharma Services Inc, Kenya 4293 Rasilez 300mg Tablets Aliskiren 300mg POM Tablet Film coated 121/039 Novartis Pharma Services Inc, Kenya 4294 Flotac Capsules Diclofenac 75mg P Capsule oral 121/040 Novartis Pharma Services Inc, Kenya Voltaren Modified Release Diclofenac Sodium P modified release 121/044 Novartis Pharma Services Inc, Kenya 4295 Tablet 100mg 100mg tablet Tizanidine Hydrochloride POM Tablet Film coated 121/046 Novartis Pharma Services Inc, Kenya Sirdalud 4 Tablets 4296 4mg POM Suspension for 040/009 Novo Nordisk (Pty) Ltd, South Africa Insulin Actrapid HM Injection Insulin 100 IU, per ml 4297 Injection POM Suspension for 040/010 Novo Nordisk (Pty) Ltd, South Africa Insulin Actrapid Penfil Injection Insulin 100 IU, per ml 4298 Injection POM Suspension for 040/011 Novo Nordisk (Pty) Ltd, South Africa Insulin Protaphane Injection Insulin 100 IU, per ml 4299 Injection Insulin Protaphane HM Penfil POM Suspension for 040/012 Novo Nordisk (Pty) Ltd, South Africa Insulin 100 IU, per ml 4300 Injection Injection POM Suspension for 040/013 Novo Nordisk (Pty) Ltd, South Africa Insulin Actraphane HM injection Insulin 100 IU, per ml 4301 Injection POM Suspension for 040/014 Novo Nordisk (Pty) Ltd, South Africa Insulin Actraphane HM Penfil Insulin 100 IU, per ml 4302 Injection POM Suspension for 040/015 Novo Nordisk (Pty) Ltd, South Africa Insulin Monotard HM Injection Insulin Zinc 40IU, per ml 4303 Injection

Page 221 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Insulin Aspart 100IU, per POM Solution for 040/016 Novo Nordisk (Pty) Ltd, South Africa Novo Rapid Injection 4304 ml Injection Insulin Detemir 100IU, POM Solution for 040/017 Novo Nordisk (Pty) Ltd, South Africa Levemir Injection 4305 per ml Injection 30% Soluble Insulin POM Solution for 040/018 Novo Nordisk (Pty) Ltd, South Africa Aspart And 70% Insulin Injection Novo Mix 30 Injection Aspart Crystallised with 4306 Protamine POM Tablets 390/001 NRB Pharma Zambia Limited Cotrix 480 Tablet Cotrimoxazole BP 480mg 4307 4308 Pyridox 25 Tablets Pyridoxine 25mg POM Tablets 390/002 NRB Pharma Zambia Limited 4309 Ison 100 Tablets Isoniazid 100mg POM Tablets 390/003 NRB Pharma Zambia Limited 4310 Ison 300 Tablets Isoniazid 300mg POM Tablets 390/004 NRB Pharma Zambia Limited 4311 Trim 200 Tablets Trimethoprim 200mg POM Tablets 390/005 NRB Pharma Zambia Limited 4312 Azibact 250 Tablets Azithromycin 250mg POM Tablets 390/006 NRB Pharma Zambia Limited 4313 Clomcet 50 Tablets Clomiphene 50mg POM Tablets 390/007 NRB Pharma Zambia Limited 4314 Quinin 300 Tablet Quinine Sulphate 300mg POM Tablets 390/008 NRB Pharma Zambia Limited 4315 Metro 200 Tablets Metronidazole 200mg POM Tablets 390/009 NRB Pharma Zambia Limited Erythromycin Stearate POM Tablet oral 390/010 NRB Pharma Zambia Limited Eryfast 250 Tablets 4316 BP 250mg Magnesium Trisilicate BP P Tablet Chewable 390/011 NRB Pharma Zambia Limited 250 mg + Dried MAGTRI-AL Chewable Tablets Aluminium Hydroxide BP 4317 120mg Chlorpheniramine P Tablet Uncoated 390/012 NRB Pharma Zambia Limited CHORPHEN 4 Tablets 4318 Maleate BP 4mg 4319 SALMOL 4 Tablets Salbutamol BP 4mg POM Tablet Uncoated 390/013 NRB Pharma Zambia Limited GSH COMPLEX®: P Powder for Oral 377/001L Nutraxis International Viprox® Powder Whey Protein Isolate + Solution 4320 Triozyme®: Sprouted P Granules for Oral 375/001L Nutrilite Access Business Group Nutrilite Sachets Multivitamins + Minerals 4321 Suspension 4322 Acfree Gel Adapalene 0.1%w/w P Gel Topical 287/001 Ochoa Laboratories Ltd, India 4323 Ultican 50 Tablets Fluconazole 50mg POM Tablet Uncoated 287/002 Ochoa Laboratories Ltd, India 4324 Ultican 150 Tablets Fluconazole 150mg POM Tablet Uncoated 287/003 Ochoa Laboratories Ltd, India 4325 Ultican 200 Tablets Fluconazole 200mg POM Tablet Uncoated 287/004 Ochoa Laboratories Ltd, India Terbinafine POM Cream Topical 287/005 Ochoa Laboratories Ltd, India Terbofin Cream 4326 Hydrochloride 1%w/w

Page 222 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Terbinafine POM Tablet Uncoated 287/006 Ochoa Laboratories Ltd, India Terbofin Tablets 4327 Hydrochloride 250mg Betamethasone POM Cream Topical 287/007 Ochoa Laboratories Ltd, India Dipropionate BP 0.05% + Exevate G Cream Gentamycin Sulphate 4328 0.1% POM Cream Topical 287/008 Ochoa Laboratories Ltd, India Betamethasone 0.05% + Xtraderm Cream Gentamycin sulphate 0.1%+ Clotrimazole 1.0% 4329 4330 Topibact Ointment Mupirocin 2% POM Ointment topical 287/009 Ochoa Laboratories Ltd, India Diclofenac Sodium 25mg, POM Solution for 287/011 Ochoa Laboratories Ltd, India Doloact Injection 4331 per ml Injection Lamivudine 150mg + POM Tablet Film coated 141/001 Okasa Pharma Limited, India Bivir 300/150mg Tablets 4332 Zidovudine 300mg Lamivudine 150mg + POM Tablet Uncoated 141/002 Okasa Pharma Limited, India Maxivir 30 Tablets Nevirapine 200mg + 4333 Stavudine 30mg Lamivudine 150 + POM Tablet Uncoated 141/003 Okasa Pharma Limited, India Maxivir 40 Tablets Nevirapine 200mg + 4334 Stavudine 40mg Lamivudine 50mg, per POM Solution for Oral 141/005 Okasa Pharma Limited, India Okavir Oral Solution 4335 5ml Use 4336 Okamune Tablets Nevirapine 200mg POM Tablet Uncoated 141/006 Okasa Pharma Limited, India POM Powder for 141/007 Okasa Pharma Limited, India Oka-Ceftriaxone Injection Ceftriaxone 1g 4337 Injection 4338 Efiva 200 Capsules Efavirenz 200mg POM Capsule oral 141/008 Okasa Pharma Limited, India POM Powder for 141/009 Okasa Pharma Limited, India Oka-Vincristine Injection Vincristine 1mg, per ml 4339 Injection 4340 Efiva 600 Tablets Efavirenz 600mg POM Tablet Uncoated 141/010 Okasa Pharma Limited, India POM Tablet Enteric 141/012 Okasa Pharma Limited, India Cefurox 500 Tablets Cefuroxime 500mg 4341 Coated 4342 Oka-Azithromycin Tablets Azithromycin 250mg POM Tablet Uncoated 141/013 Okasa Pharma Limited, India 4343 Okavir S 30 Tablets Stavudine 30mg POM Tablet Uncoated 141/014 Okasa Pharma Limited, India Artemether 15mg, per POM Suspension for 141/016 Okasa Pharma Limited, India Artheleria Oral Suspension 4344 5ml Oral Use 4345 Ibuprofen Tablets Ibuprofen 200mg P Tablet Film coated 141/017 Okasa Pharma Limited, India

Page 223 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Ammonium Chloride BP P Syrup 258/001 Oman Pharmaceutical Products Co. LLC, 138mg + Oman Viscodril Expectorant Syrup Diphenylhydramine 4346 Hydrochloride BP 14mg POM Cream Topical 258/002 Oman Pharmaceutical Products Co. LLC, Opizole Cream Clotrmazole USP 1%w/w 4347 Oman Diclofenac Diethylamine P Gel Topical 258/003 Oman Pharmaceutical Products Co. LLC, Clofast Gel 4348 BP 1%w/w Oman Metformin Hydrochloride POM Tablet Uncoated 258/004 Oman Pharmaceutical Products Co. LLC, Dimet 650 Tablets 4349 BP 650mg Oman Metformin Hydrochloride POM Tablet Uncoated 258/005 Oman Pharmaceutical Products Co. LLC, Dimet 500 Tablets 4350 BP 500mg Oman Sodium Citrate 55mg + P Syrup 258/006 Oman Pharmaceutical Products Co. LLC, Chlorpheniramine 2.5mg Oman Medicoril-E Syrup + Ammonium Chloride 4351 125mg POM Tablet Uncoated 258/007 Oman Pharmaceutical Products Co. LLC, Atormin 50 Tablets Atenolol BP 50mg 4352 Oman POM Tablet Uncoated 258/008 Oman Pharmaceutical Products Co. LLC, Atormin 100 Tablets Atenolol BP 100mg 4353 Oman Paracetamol BP 120mg, GS Syrup 258/009 Oman Pharmaceutical Products Co. LLC, Pmol Syrup 4354 per 5ml Oman GS Capsule oral 258/010 Oman Pharmaceutical Products Co. LLC, Pmol Caplets Paracetamol BP 500mg 4355 Oman 4356 OraQuick - HIV Self-Test Kit HIV Self-Test Kit P HDPE Strips 412/001 OraSure Technologies 4357 Cefacure Capsules Cephalexin USP 250mg POM Capsule oral 185/001 Orchid Healthcare Limited, India 4358 Cefacure Capsules Cephalexin USP 500mg POM Capsule oral 185/002 Orchid Healthcare Limited, India Ceftriaxone Sodium POM Powder for 185/003 Orchid Healthcare Limited, India Cefogram Injection 4359 250mg Injection Ceftriaxone Sodium POM Powder for 185/004 Orchid Healthcare Limited, India Cefogram Injection 4360 1000mg Injection POM Powder for 185/005 Orchid Healthcare Limited, India Orzid Injection Ceftazidine 500mg 4361 Injection POM Powder for 185/006 Orchid Healthcare Limited, India Orzid Injection Ceftazidine 1000mg 4362 Injection Cefotaxime Sodium POM Powder for 185/007 Orchid Healthcare Limited, India Tax-O -BID Injection 4363 1000mg Injection Cefotaxime Sodium POM Powder for 185/008 Orchid Healthcare Limited, India Tax-O-BID Injection 4364 500mg Injection

Page 224 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Cefotaxime Sodium POM Powder for 185/009 Orchid Healthcare Limited, India Tax-O-BID Injection 4365 250mg Injection Cefuroxime Axetil I.H. POM Tablet Uncoated 185/010 Orchid Healthcare Limited, India Spizef 250 Tablets 4366 250mg Cefuroxime Axetil I.H. POM Tablet Uncoated 185/011 Orchid Healthcare Limited, India Spizef 500 Tablets 4367 500mg 4368 Ulti-Mate 50 Sildenafil Tablets Sildenafil Citrate I. 50mg POM Tablet Uncoated 185/012 Orchid Healthcare Limited, India Sildenafil Citrate I. POM Tablet Uncoated 185/013 Orchid Healthcare Limited, India Ulti-Mate 100 Sildenafil Tablets 4369 100mg Cefepime Hydrochloride POM Powder for 185/014 Orchid Healthcare Limited, India Orpime Injection 4370 1g Injection 4371 Orfix Capsules Cefixime Soduim 200mg POM Capsule oral 185/015 Orchid Healthcare Limited, India 4372 Manorest Tablets Alprazolam 0.5mg POM Tablet Uncoated 185/016 Orchid Healthcare Limited, India Cefpodoxime Proxetil POM Tablet Uncoated 185/017 Orchid Healthcare Limited, India Cepotil 200 Tablets 4373 USP 200mg Cefpodoxime Proxetil POM Tablet Uncoated 185/018 Orchid Healthcare Limited, India Cepotil 100 Tablets 4374 USP 100mg Enalapril Maleate USP POM Tablet Uncoated 185/019 Orchid Healthcare Limited, India E-Pril -10 Tablets 4375 10mg Enalapril Maleate USP POM Tablet Uncoated 185/020 Orchid Healthcare Limited, India Epril 5 Tablets 4376 5mg 4377 Monorest Tablets Alprazolam USP 0.25mg POM Tablet Uncoated 185/021 Orchid Healthcare Limited, India Ciprofloxacin USP POM Solution for 194/009 Otsuka Pharmaceuticals India Pvt Ltd Ciprox Injection 4378 200mg, per 100ml Injection Metronidazole USP 5mg, POM Solution for 194/013 Otsuka Pharmaceuticals India Pvt Ltd Metris Injection 4379 per ml Injection POM Solution for 194/015 Otsuka Pharmaceuticals India Pvt Ltd Dextrose Intravenous Infusion Glucose 50g/L 4380 infusion Sodium Chloride 0.9w/v + POM Solution for 194/016 Otsuka Pharmaceuticals India Pvt Ltd Sodium Chloride And Glucose 4381 Glucose 5%w/v infusion POM Solution for 194/017 Otsuka Pharmaceuticals India Pvt Ltd Sodium Chloride Injection Sodium Chloride 0.9% 4382 infusion POM Solution for 194/018 Otsuka Pharmaceuticals India Pvt Ltd Compound Sodium Lactate Ringer's Lactate 4383 infusion Gentamycin 80mg, per POM Solution for 213/001 Ouyi Pharma Co.Ltd, China Gentamycin Sulphate Injection 4384 2ml Injection Losartan Potassium USP POM Tablet Uncoated 138/001 Palash Pharma Palsar Tablets 4385 50mg

Page 225 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Sitcom Cream Euphorbia prostrata dry P Cream Topical 439/001 Panacea Biotech Limited extract ethanolic 80% 4386 w/w Sitcom Tablets Euphorbia prostrata dry P Tablet Film coated 439/002 Panacea Biotech Limited 4387 extract POM Tablet Uncoated 120/001 Pfizer Global Pharmaceuticals Ltd, South Diflucan 200mg Tablets Fluconazole 200mg 4388 Africa POM Tablet Uncoated 120/002 Pfizer Global Pharmaceuticals Ltd, South Zithromax Tablets Azithromycin 500mg 4389 Africa POM Tablet Uncoated 120/003 Pfizer Global Pharmaceuticals Ltd, South Viagra Tablets Sildenafil 50mg 4390 Africa POM Tablet Uncoated 120/004 Pfizer Global Pharmaceuticals Ltd, South Viagra Tablets Sildenafil 25mg 4391 Africa POM Tablet Uncoated 120/005 Pfizer Global Pharmaceuticals Ltd, South Liptor Tablets Atorvastatin 10mg 4392 Africa POM Tablet Uncoated 120/006 Pfizer Global Pharmaceuticals Ltd, South Liptor Tablets Atorvastatin 20mg 4393 Africa POM Tablet Uncoated 120/007 Pfizer Global Pharmaceuticals Ltd, South Diflucan 150mg Tablets Fluconazole 150mg 4394 Africa POM Tablet Uncoated 120/008 Pfizer Global Pharmaceuticals Ltd, South Feldene Tablets Piroxcam 20mg 4395 Africa POM Tablet Uncoated 120/009 Pfizer Global Pharmaceuticals Ltd, South Diflucan 50mg Tablets Fluconazole 50mg 4396 Africa POM Tablet Uncoated 120/010 Pfizer Global Pharmaceuticals Ltd, South Fasigyn Tablets Tinidazole 150mg 4397 Africa POM Eye Drops 120/011 Pfizer Global Pharmaceuticals Ltd, South Xalatan Eye Drops Latanoprost 0.005% 4398 Africa Medroxyprogesterone POM Suspension for 120/012 Pfizer Global Pharmaceuticals Ltd, South Depo Provera Injection 4399 Acetate 150mg, per ml Injection Africa POM Tablet Uncoated 120/013 Pfizer Global Pharmaceuticals Ltd, South Norvasc Tablets Amlodipine 5mg 4400 Africa 10 Mg Oxytetracycline+ 5 POM Ear/Eye Drops 120/014 Pfizer Global Pharmaceuticals Ltd, South Mg Hydrocortisone Africa Terra-Cotril Eye/Ear Drops Acetate +10000 Units Polymyxin B Sulphate, 4401 per ml POM Solution for 120/015 Pfizer Global Pharmaceuticals Ltd, South Feldene Injection Piroxcam 20mg, per ml 4402 Injection Africa

Page 226 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER POM Tablet Uncoated 120/017 Pfizer Global Pharmaceuticals Ltd, South Prostine E 2 Vaginal Tablets Dinoprostone HSE 3mg 4403 Africa POM Capsule oral 120/018 Pfizer Global Pharmaceuticals Ltd, South Feldene Capsules Piroxcam 10mg 4404 Africa POM Solution for 120/021 Pfizer Global Pharmaceuticals Ltd, South Trobicin Injection Specitinomycin 3mg 4405 Injection Africa Methylprednisolone POM Solution for 120/022 Pfizer Global Pharmaceuticals Ltd, South Depo Medrol Injection 4406 40mg, per ml Injection Africa POM Capsule oral 120/023 Pfizer Global Pharmaceuticals Ltd, South Dalacin C 150mg Capsules Clindamycin 150mg 4407 Africa POM Tablet Uncoated 120/024 Pfizer Global Pharmaceuticals Ltd, South Accupril Tablets Quinapril 5mg 4408 Africa POM Tablet Uncoated 120/025 Pfizer Global Pharmaceuticals Ltd, South Accupril Tablets Quinapril 10mg 4409 Africa Hydrochlothiazide POM Tablet Uncoated 120/026 Pfizer Global Pharmaceuticals Ltd, South Accupretic Tablets 12.5mg + Quinapril Africa 4410 10mg P Capsule oral 120/027 Pfizer Global Pharmaceuticals Ltd, South Ponstan Capsules Mefenamic Acid 250mg 4411 Africa Mefenamic Acid 50mg, P Suspension for 120/028 Pfizer Global Pharmaceuticals Ltd, South Ponstan Suspension 4412 per 5ml Oral Use Africa POM Gel Topical 120/029 Pfizer Global Pharmaceuticals Ltd, South Feldene Topical Gel Piroxcam 0.5% 4413 Africa Azithromycin 200mg, per POM Suspension for 120/030 Pfizer Global Pharmaceuticals Ltd, South Zithromax Suspension 4414 5ml Oral Use Africa Medroxyprogesterone POM Solution for 120/031 Pfizer Global Pharmaceuticals Ltd, South Sayana Injection 4415 104mg, per 0.65ml Injection Africa POM Capsule oral 120/032 Pfizer Global Pharmaceuticals Ltd, South Mycobutin Capsules Rifabutin 150mg 4416 Africa POM Capsule oral 198/008 Pfizer Global Pharmaceuticals Ltd, South Dalacin C Capsules Clindamycin 150mg 4417 Africa 4418 Cytotec Tablets Misoprostol 200mcg POM Tablet Uncoated 120/037 Pfizer Global Pharmaceuticals Ltd,Nigeria Atorvastalin Calcium POM Tablet Uncoated 357/001 Pfizer Global Pharmaceuticals Ltd,Nigeria ASPAVOR 10 Tablets 4419 Trihydrate 10mg Atorvastalin Calcium POM Tablet Uncoated 357/002 Pfizer Global Pharmaceuticals Ltd,Nigeria ASPAVOR 20 Tablets 4420 Trihydrate 20mg Atorvastalin Calcium POM Tablet Uncoated 357/003 Pfizer Global Pharmaceuticals Ltd,Nigeria ASPAVOR 40 Tablets 4421 Trihydrate 40mg

Page 227 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Sayana Press® Pre-Filled Medroxyprogesterone Prescription Only Suspension for 120/038 Pfizer Laboratories Limited, Kenya Single-Use Suspension For Acetate 104mg, per Medicine Injection 4422 Injection System 0.65ml Cardura XL tablets Doxazosin mesyltate 4mg POM Tablet Modified 120/039 Pfizer Laboratories Limited, Kenya 4423 Release Cadura XL tablets Doxazosin mesyltate 8mg POM Tablet Modified 120/040 Pfizer Laboratories Limited, Kenya 4424 Release 4425 Tetracycline Capsules Tetracycline 250mg POM Capsule oral 131/008 Pharco Limited,Zambia Lamivudine 150mg + POM Tablet Uncoated 132/002 Pharco Limited,Zambia Normavir Tablets Stavudine 30mg + 4426 Nevirapine 300mg 4427 Cimetidine Tablets Cimetidine 100mg POM Tablet Uncoated 132/003 Pharco Limited,Zambia Chlorpheniramine P Tablet Uncoated 132/004 Pharco Limited,Zambia Chlorpheniramine Tablets 4428 Maleate 4mg POM Tablet Uncoated 132/005 Pharco Limited,Zambia Sulfamethoxazole 400mg Co-Trimoxazole Tablets + Trimethoprim 80mg 4429 4430 Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 132/006 Pharco Limited,Zambia 4431 Folic Acid Tablets Folic Acid 5mg P Tablet Uncoated 132/007 Pharco Limited,Zambia 4432 Pyrazinamide Tablets Pyrazinamide 500mg POM Tablet Uncoated 132/009 Pharco Limited,Zambia 4433 Paracetamol Tablets Paracetamol 100mg GS Tablet Uncoated 132/010 Pharco Limited,Zambia 4434 Paracetamol Tablets Paracetamol 500mg GS Tablet Uncoated 132/011 Pharco Limited,Zambia Sulphadoxine/Pyrimethamine Pyrimethamine 25mg + POM Tablet Uncoated 132/012 Pharco Limited,Zambia 4435 Tablets Sulphadoxine 500mg 4436 Carbamazepine Tablets Carbamazepine 200mg POM Tablet Uncoated 132/013 Pharco Limited,Zambia Metoclopramide BP POM Tablet Uncoated 132/014 Pharco Limited,Zambia Metoclopramide Tablets 4437 10mg 4438 Quinine Sulphate Tablets Quinine Sulphate 300mg POM Tablet Uncoated 132/015 Pharco Limited,Zambia 4439 Zarin Sino II Implant Levenorgestrel 75mg POM Transdermal Rod 081/001 Pharm Access Africa Ltd, Kenya POM Tablet Uncoated 051/001 Pharma Dynamics (Pty) Limited, South Dynafloc 500 Tablets Ciprofloxacin 500mg 4440 Africa Paracetamol 500mg + P Tablet Dispersible 051/002 Pharma Dynamics (Pty) Limited, South Efferflu C Effervesent Tablets Vitamin C 250mg + Africa 4441 Chlorpheniramine 2mg P Syrup 051/003 Pharma Dynamics (Pty) Limited, South Pollentymes S Syrup Loratadine 5mg, per 5mls 4442 Africa P Syrup 051/004 Pharma Dynamics (Pty) Limited, South Texa Syrup Cetirizine 1mg, per ml 4443 Africa

Page 228 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER P Tablet Uncoated 051/005 Pharma Dynamics (Pty) Limited, South Texa 10mg Tablets Cetirizine 10mg 4444 Africa POM Tablet Film coated 051/006 Pharma Dynamics (Pty) Limited, South Enap 5mg Tablets Enalapril 5mg 4445 Africa POM Tablet Film coated 051/007 Pharma Dynamics (Pty) Limited, South Enap 10 Tablets Enalapril 10mg 4446 Africa POM Tablet Film coated 051/008 Pharma Dynamics (Pty) Limited, South Enap 20 Tablets Enalapril 20mg 4447 Africa P Tablet Film coated 051/009 Pharma Dynamics (Pty) Limited, South Pollentyme Tablets Loratadine 10mg 4448 Africa Tea Tree Oil 200mg + GS Solution for Oral 051/010 Pharma Dynamics (Pty) Limited, South Oradoc Gargle & Mouth Wash Eucalyptol 18mg + Use Africa 4449 Thymol 13mg Enalapril 20mg + POM Tablet Film coated 051/011 Pharma Dynamics (Pty) Limited, South Enap - Co Tablets Hydrochlorothiazide Africa 4450 12.5mg POM Tablet Uncoated 051/012 Pharma Dynamics (Pty) Limited, South Pearinda 4 Tablets Perindopril 4mg 4451 Africa POM Tablet Uncoated 051/013 Pharma Dynamics (Pty) Limited, South Pearinda 8 Tablets Perindopril 8mg 4452 Africa POM Tablet Uncoated 051/014 Pharma Dynamics (Pty) Limited, South Carvetrend 6.25mg Tablets Carvedilol 6.25mg 4453 Africa POM Tablet Uncoated 051/015 Pharma Dynamics (Pty) Limited,South Carvetrend 12.5mg Tablets Carvedilol 12.5mg 4454 Africa Vitamin C 1000.0mg + POM Tablet uncoated 051/016 Pharma Dynamics (Pty) Limited,South Echinacea Purpurea Africa Efferflu C IB 50mg + Zinc Lactate 4455 Trihydrate 22.71mg Medroxyprogesteron POM Solution for 247/001 Pharmacarechem International Ltd, England Depogest Injection 4456 USP 150mg Injection Cloxacillin 125mg, per POM Syrup 247/002 Pharmacarechem International Ltd, England Cloxacillin Dry Syrup 4457 5ml Amoxicillin 125mg, per POM Suspension for 247/003 Pharmacarechem International Ltd, England Amoxicillin Dry Syrup 4458 5ml Oral Use Erythromycin BP 125mg, POM Suspension for 247/004 Pharmacarechem International Ltd, England Erythromycin Oral Suspension 4459 per 5ml Oral Use Ampicillin 125mg, per POM Syrup 247/005 Pharmacarechem International Ltd, England Ampicillin Dry Syrup 4460 5ml

Page 229 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Phenoxymethyl Penicillin Phenoxymethyl Penicillin POM Suspension for 247/006 Pharmacarechem International Ltd, England 4461 Suspension USP 125mg, per 5ml Oral Use POM Solution for 198/001 Pharmacia & Upjohn Worldwide, Solu Medrol Injection Methylprednisolone 40mg 4462 Injection Kalamazoo, U.S.A POM Tablet Uncoated 198/002 Pharmacia & Upjohn Worldwide, Medrol Tablets Methylprednisolone 4mg 4463 Kalamazoo, U.S.A POM Tablet Uncoated 198/003 Pharmacia & Upjohn Worldwide, Halcion Tablets Triazolam 0.25mg 4464 Kalamazoo, U.S.A POM Eye Drops 198/005 Pharmacia & Upjohn Worldwide, Xalatan Eye Drops Latanoprost 50mg 4465 Kalamazoo, U.S.A Medroxyprogesterone POM Tablet Uncoated 198/006 Pharmacia & Upjohn Worldwide, Provera Tablets 4466 5mg Kalamazoo, U.S.A POM Solution for 198/007 Pharmacia & Upjohn Worldwide, Dalacin C Injection Clindamycin 150mg 4467 Injection Kalamazoo, U.S.A Clindamycin 75mg, per POM Solution for Oral 198/009 Pharmacia & Upjohn Worldwide, Dalacin C Syrup 4468 5ml Use Kalamazoo, U.S.A POM Powder for 198/010 Pharmacia & Upjohn Worldwide, Caverject Powder for Injection Alprostadil 20mcg 4469 Injection Kalamazoo, U.S.A Sulfur 50mg + POM Lotion for Topical 198/011 Pharmacia & Upjohn Worldwide, Methyprednisolone Use Kalamazoo, U.S.A Neo Medrol Acne Lotion 2.5mg + Neomycin 2.5mg + Aluminium 4470 Chlorohydrate 100mg Hydrocortisone Sodium POM Powder for 198/012 Pharmacia & Upjohn Worldwide, Solu Cortef Injection 4471 Succinate 100mg Injection Kalamazoo, U.S.A P Capsules Oral 198/013 Pharmacia & Upjohn Worldwide, Unicarp M Capsules Multivitamins 4472 Kalamazoo, U.S.A POM Powder for 198/015 Pharmacia & Upjohn Worldwide, Togamycin Injection Specitinomycin 2g 4473 Injection Kalamazoo, U.S.A Medroxyprogesterone POM Suspension for 198/016 Pharmacia & Upjohn Worldwide, Depo Provera Injection 4474 150mg Injection Kalamazoo, U.S.A Amlodipine Besylate POM Tablet Uncoated 357/004 Pharmacia South Africa (Pty) Ltd Lomanor 10 Tablets 4475 10mg POM Tablet Uncoated 357/005 Pharmacia South Africa (Pty) Ltd Lomanor 5 Tablets Amlodipine Besylate 5mg 4476 Quinapril Hydrochloride POM Tablet Enteric 357/006 Pharmacia South Africa (Pty) Ltd Accumax 10mg Tablets 4477 10mg Coated Quinapril Hydrochloride POM Tablet Film coated 357/007 Pharmacia South Africa (Pty) Ltd Accumax 20mg Tablets 4478 20mg

Page 230 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Quinapril Hydrochloride POM Tablet Film coated 357/008 Pharmacia South Africa (Pty) Ltd 10mg + Accumax Co 10/12.5mg Tablets Hydrochlorothiazide 4479 12.5mg Quinapril Hydrochloride POM Tablet Film coated 370/013L Pharmacia South Africa (Pty) Ltd 20mg + Accumax Co 20/12.5mg Tablets Hydrochlorothiazide 4480 12.5mg 4481 Closcript Vaginal Cream Clotrimazole 1% POM Cream Topical 017/001 Pharmanova (Pty) Ltd, Zimbabwe 4482 Closcript Topical Cream Clotrimazole 1% POM Cream Topical 017/002 Pharmanova (Pty) Ltd, Zimbabwe Paracetamol + Codeine + P Syrup 017/003 Pharmanova (Pty) Ltd, Zimbabwe Goldgesic Syrup 4483 Meprobamate 4484 Grays Eye Drops Tetrahydrozoline 0.05% POM Eye Drops 017/004 Pharmanova (Pty) Ltd, Zimbabwe Paracetamol + Codeine + P Tablet Uncoated 017/005 Pharmanova (Pty) Ltd, Zimbabwe Goldgesic Tablets 4485 Meprobamate 4486 Pain-Eeze Tabs Aspirin + Caffeine P Tablets oral 017/006 Pharmanova (Pty) Ltd, Zimbabwe Grays Pine Tar & Honey P Syrup 017/007 Pharmanova (Pty) Ltd, Zimbabwe Grays Cough Syrup 4487 Cough Syrup 4488 Novadol Tablets Paracetamol 500mg GS Tablet Uncoated 017/009 Pharmanova (Pty) Ltd, Zimbabwe 4489 Novadol Syrup Paracetamol 120mg GS Syrup 017/010 Pharmanova (Pty) Ltd, Zimbabwe Sulphamethoxazole POM Suspension for 017/011 Pharmanova (Z) Ltd, Lusaka, Zambia Novatrim Suspension 200mg + Trimethoprim Oral Use 4490 40mg, per 5ml Aspirin 500mg + Caffeine GS Tablet Uncoated 077/001 Pharmanova (Z) Ltd, Lusaka, Zambia Adult Cafemol Tablets 4491 15mg 4492 Child Cafemol Tablets Aspirin 80mg GS Tablet Uncoated 077/002 Pharmanova (Z) Ltd, Lusaka, Zambia 4493 Panado Tablets Paracetamol 500mg GS Tablet Uncoated 077/003 Pharmanova (Z) Ltd, Lusaka, Zambia P Powder for Topical 077/006 Pharmanova (Z) Ltd, Lusaka, Zambia Novaderm Dusting Powder Clotrimazole 1%w/w 4494 use Sodium Bicarbonate GS Solution for Oral 077/007 Pharmanova (Z) Ltd, Lusaka, Zambia 50mg, Sodium Citrate Use Phipps Gripe Water 2.5mg, Sucrose 120mg, Spearmint Oil 0.14mg, 4495 0.1mg/50ml Trimethoprim 80mg + POM Tablet Uncoated 077/008 Pharmanova (Z) Ltd, Lusaka, Zambia Novatrim Tablets 4496 Sulphadoxine 400mg Pyrimethamine 25mg + P Tablet Uncoated 077/009 Pharmanova (Z) Ltd, Lusaka, Zambia Novidar Tablets 4497 Sulphadoxine 500mg

Page 231 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Paracetamol 125mg, per P Syrup 077/010 Pharmanova (Z) Ltd, Lusaka, Zambia Panado Syrup 4498 5ml Magnesium + Sodium GS Powder for Oral 077/011 Pharmanova (Z) Ltd, Lusaka, Zambia Drews Liver Salt 4499 Bicarbonate 3.165gm Solution Padax 1.65g (Piperazine POM Powder 077/012 Pharmanova (Z) Ltd, Lusaka, Zambia Piperazine Citrate 1.65g 4500 Citrate) 4501 Metronidazole 200mg Tabs Metronidazole 200mg POM Tablets oral 077/013 Pharmanova (Z) Ltd, Lusaka, Zambia Trimethoprim 80mg + POM Tablet Uncoated 077/014 Pharmanova (Z) Ltd, Lusaka, Zambia Co-trimoxazole Tablets 4502 Sulphadoxine 400mg 4503 Novafen 200mg Capsules Ibuprofen 200mg P Capsules oral 077/015 Pharmanova (Z) Ltd, Lusaka, Zambia 4504 Tetracycline 250mg Caps Tetracyline 250mg POM Capsules oral 077/016 Pharmanova (Z) Ltd, Lusaka, Zambia Diphenyhydramine P Syrup 077/017 Pharmanova (Z) Ltd, Lusaka, Zambia Hydrochloride 14mg + Ammonium Chloride Novalyn Cough Syrup 138mg + Sodium Citrate 57.3mg + Menthol 2g, per 4505 5ml Acetyl Salicylic Acid P Tablet Uncoated 077/018 Pharmanova (Z) Ltd, Lusaka, Zambia Aspirin Tablets 4506 300mg Sodium Chloride 2.6g + GS Powder for Oral 077/019 Pharmanova (Z) Ltd, Lusaka, Zambia Sodium Citrate2.9g + Solution Novalyte ORS Potassium Chloride1.5g + Anhydrous Glucose 4507 13.5g Sulfadoxine 500mg + POM Tablet Uncoated 077/020 Pharmanova (Z) Ltd, Lusaka, Zambia Novidar Plus Tablets Pyrimethamine 25mg + 4508 Artesunate 100mg Chlorpheniramine 2mg, P Syrup 077/021 Pharmanova (Z) Ltd, Lusaka, Zambia Novachlor Syrup 4509 per 5ml Paracetamol 400mg + P Capsules oral 077/022 Pharmanova (Z) Ltd, Lusaka, Zambia Caffeine 30mg + Nocold Capsules Chlorpheniramine 4mg + 4510 Pseudoephedrine 30mg 4511 Child Panado Tablets Paracetamol 100mg GS Tablet Uncoated 077/023 Pharmanova (Z) Ltd, Lusaka, Zambia Ibuprofen 200mg + P Tablet Uncoated 077/024 Pharmanova (Z) Ltd, Lusaka, Zambia Panado Plus Tablets 4512 Paracetamol325mg 4513 Novazinc Tablets Zinc Sulfate 20mg GS Tablet Uncoated 077/025 Pharmanova (Z) Ltd, Lusaka, Zambia ORS + Zinc Sulphate GS Kit 077/026 Pharmanova (Z) Ltd, Lusaka, Zambia Kit Yamoyo the Flexi Pack Kit 4514 200mg + 1 Hand Soap

Page 232 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER ORS + Zinc Sulphate GS kit 077/027 Pharmanova (Z) Ltd, Lusaka, Zambia Yamoyo Screw Top Kit 4515 200mg + 1 Hand Soap ORS + Zinc Sulphate GS Kit 077/028 Pharmanova (Z) Ltd, Lusaka, Zambia Yamoyo GRZ Co-Pack 4516 200mg 4517 Aspirin Tablets 300mg Aspirin 300mg P Tablet Uncoated 257/001 Pharmanova Limited, Malawi Magnesium Hydroxide GS Suspension for 257/002 Pharmanova Limited, Malawi Phipps Milk Of Magnesia 4518 400mg, per 5ml Oral Use 4519 Panadol Tablets For Children Paracetamol 100mg GS Tablet Uncoated 257/003 Pharmanova Limited, Malawi Salicylic Acid 0.014% + GS Syrup 257/019 Pharmanova Limited, Malawi Ammonium Chloride Stearns Pine Tar 1.15% + Hexysuranal 4520 0.1% + Alcohol 1.6% Betamethasone 4mg, per POM Solution for 034/001 Pharma-Q Holdings (Pty) Ltd, South Africa Micro Betamethasone Injection 4521 ml Injection Micro Bupivacaine Spinal with Bupivacaine + Dextrose POM Solution for 034/002 Pharma-Q Holdings (Pty) Ltd, South Africa 4522 Dextrose Injection 20mg, per 4ml Injection Dopamine Hydrochloride POM Solution for 034/003 Pharma-Q Holdings (Pty) Ltd, South Africa Micro Dopamine Injection 4523 200mg, per 5ml Injection Bupivacaine POM Solution for 034/004 Pharma-Q Holdings (Pty) Ltd, South Africa Pharma Q Bupivacaine Injection Hydrochloride 50mg, per Injection 50mg/10ml Injection 4524 10ml Pharma -Q Gentamicin Gentamycin Sulphate POM Solution for 034/005 Pharma-Q Holdings (Pty) Ltd, South Africa 4525 80mg/2ml Injection 80mg, per 2ml Injection Pharma-Q Metoclopramide Metoclopramide POM Solution for 034/006 Pharma-Q Holdings (Pty) Ltd, South Africa 4526 Injection Hydrochloride 10mg Injection Pharma-Q Hyocine POM Solution for 034/007 Pharma-Q Holdings (Pty) Ltd, South Africa Hyocine Butylbromide Butylbromide Injection Injection 20mg 4527 20mg/2ml Pharma-Q Clindamycin Injection Clindamycin Phosphate POM Solution for 034/008 Pharma-Q Holdings (Pty) Ltd, South Africa 4528 600mg/4ml 600mg, per 4ml Injection Adrenaline Hydrochloride POM Solution for 034/009 Pharma-Q Holdings (Pty) Ltd, South Africa Pharma-Q Adrenalin Injection 4529 1mg Injection Pethidine Hydrochloride POM Solution for 034/010 Pharma-Q Holdings (Pty) Ltd, South Africa Pharma-Q Pethidine Injection 4530 100mg Injection Diclofenac Sodium 75mg, POM Solution for 034/011 Pharma-Q Holdings (Pty) Ltd, South Africa Pharma-Q Diclofenac Injection 4531 per 3ml Injection Pharma-Q Dexamethasone Dexamethasone Sodium POM Solution for 034/012 Pharma-Q Holdings (Pty) Ltd, South Africa 4532 Phosphate Injection Phosphate 4.0mg Injection 4533 Larvin Tablets Clopidogrel 75mg POM Tablet Film coated 320/001 Pharmex SA

Page 233 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Fusidic Acid 2%w/w + POM Cream Topical 320/002 Pharmex SA Butafusin Cream Betamethasone Valerate 4534 0.1% 4535 Cipocal Cream Calcipotriol 0.005% POM Cream Topical 320/003 Pharmex SA Dorzalamide POM Eye Drops 320/004 Pharmex SA Phardinol Eye Drop Solution Hydrochloride 2.0% + 4536 Timolol Maleate 0.5% Calcipotriol (Anhydrous), GS Ointment topical 320/005 Pharmex SA Cipocal Ointment 4537 0.005% P Solution for Oral 078/001HM Phend Pharmaceuticals Pty Ltd, China Qina Drops Herbal Extracts 4538 Use Propovan Injection, 20ml POM Suspension for 103/005 Piramal Healthcare Limited, India Propofol 1% 4539 Ampoule Injection Mentha Piperata 1.89mg GS Lozenges 037/001 Plethico Pharmaceuticals Limited, India Actifresh Lozenges - Regular + Eucalyptus Globules 4540 0.65mg Camphor + Turpentine + GS Ointment topical 037/002 Plethico Pharmaceuticals Limited, India Travisil Cold Rub Menthol + Eucalyptus Oil 4541 + Thymol + Nutmeg Amylmetacresol 0.6mg + GS Lozenges 037/003 Plethico Pharmaceuticals Limited, India Therasil Sore Throat Formula 2,4 Dichlorobenzyl Lozenges 4542 Alcohol 1.2mg POM Solution for 037/004 Plethico Pharmaceuticals Limited, India Artemal M Injection Artemether 80mg, per ml 4543 Injection POM Solution for 037/005 Plethico Pharmaceuticals Limited, India Falquin 600 Injection Quinine 600mg, per 2ml 4544 Injection Trimethoprim 80mg + POM Tablet Uncoated 037/006 Plethico Pharmaceuticals Limited, India Timizol Tablets Sulphamethoxazole 4545 400mg 4546 Taxocef -O 200 Tablets Cefixime 200mg POM Tablet Uncoated 037/007 Plethico Pharmaceuticals Limited, India Travisil Herbal Cough Lemon GS Lozenges 037/008 Plethico Pharmaceuticals Limited, India Herbal Extract 4547 Flavoured Lozenges Travisil Herbal Cough Mint GS Lozenges 037/009 Plethico Pharmaceuticals Limited, India Herbal Extract 4548 Flavour Lozenges 4549 Travisil Herbal Cough Syrup Herbal Extract GS Syrup 037/010 Plethico Pharmaceuticals Limited, India Paracetamol 500mg + P Tablet Uncoated 037/011 Plethico Pharmaceuticals Limited, India Phenylephrine 5mg + Fastorik Tablets Chlorpheniramine 4mg + 4550 Caffeine 30mg

Page 234 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 4551 Cloptaz Tablets Clopidogrel 75mg POM Tablet Film coated 037/012 Plethico Pharmaceuticals Limited, India Aluminium Hydroxide POM Suspension for 037/013 Plethico Pharmaceuticals Limited, India 300mg + Magnesium Oral Use Trisilicate 50mg + Coolz Suspension Magnesium Hydroxide 25mg + Simethicone 4552 25mg Cefepime Hydrochloride POM Powder for 037/014 Plethico Pharmaceuticals Limited, India Forcepime 1g Injection 4553 1g Injection Diclofenac Sodium 75mg, POM Solution for 037/015 Plethico Pharmaceuticals Limited, India Maxi 75 Injection 4554 per 3ml Injection Terbinafine POM Cream Topical 037/016 Plethico Pharmaceuticals Limited, India Terbact Cream 4555 Hydrochloride 1%w/w POM Solution for 183/001 Preterius Patents CC, South Africa Q-Med Adrenaline Injection Adrenaline 4556 Injection 4557 Alphacillin 250 Capsules Ampicillin 250mg POM Capsule oral 265/001 Prime Pharmaceuticals Ltd, India 4558 Acyzon Tablets Acyclovir 200mg POM Tablet Uncoated 265/002 Prime Pharmaceuticals Ltd, India Ketaconazole USP POM Tablet Uncoated 265/004 Prime Pharmaceuticals Ltd, India Ketoniz Tablets 4559 200mg POM Solution for 246/001 Prisma Pharmaceuticals Ltd, UK Clotflush Injection Heparin 100IU 4560 Injection POM Powder for 246/002 Prisma Pharmaceuticals Ltd, UK Priskacin 250 Injection Amikacin 250mg 4561 Injection 4562 Purecal Tablets Calcium 1250mg POM Tablet Uncoated 246/003 Prisma Pharmaceuticals Ltd, UK POM Powder for 246/004 Prisma Pharmaceuticals Ltd, UK Priskacin 500 Injection Amikacin 500mg 4563 Injection Sodium Hyaluronate POM Solution for 246/005 Prisma Pharmaceuticals Ltd, UK Synolube Injection 4564 20mg Injection POM Powder for 246/009 Prisma Pharmaceuticals Ltd, UK Odicef 1000 Injection Ceftriaxone 1000mg 4565 Injection POM Powder for 246/010 Prisma Pharmaceuticals Ltd, UK Odicef 50 Injection Ceftriaxone 50mg 4566 Injection POM Powder for 246/011 Prisma Pharmaceuticals Ltd, UK Odicef 250 Injection Ceftriaxone 250mg 4567 Injection Amoxicillin 1000mg + POM Powder for 246/014 Prisma Pharmaceuticals Ltd, UK Clavex Injection Clavulanate Potassium Injection 4568 200mg Enoxaparin 80mg, per POM Solution for 246/016 Prisma Pharmaceuticals Ltd, UK LMW Enox Injection 4569 0.8ml Injection

Page 235 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Enoxaparin 40mg, per POM Solution for 246/017 Prisma Pharmaceuticals Ltd, UK LMW Enox Injection 4570 0.4ml Injection Enoxaparin 60mg, per POM Solution for 246/018 Prisma Pharmaceuticals Ltd, UK LMW Enox Injection 4571 0.6ml Injection 4572 Kefurox 250 Mg Tablets Cefuroxime 250mg POM Tablet Film coated 246/019 Prisma Pharmaceuticals Ltd, UK 4573 Kefurox 500mg Tablets Cefuroxime 500mg POM Tablet Film coated 246/020 Prisma Pharmaceuticals Ltd, UK EAZZ UP + Pain Relief Cream Methyl Salicylate + P Cream Topical 435/002L PSA Chemicals and Pharmaceuticals Pvt Peppermint Oil + Sallaki Ltd 4574 oil + Bakuchi KIDOGRIP Gripe Water Sodium bicarbonate BP P Solution for Oral 435/003L PSA Chemicals and Pharmaceuticals Pvt 4575 1% w/v Use Ltd 4576 Amoxsan® 250 DT Amoxicillin Trihydrate POM Tablet Dispersible 631/001 PT CAPRIFARMINDO LABORATORIES Sulphamethoxazole BP POM Tablet Uncoated 162/001 Pure pharma Limited, India Co-Trimoxazole Tablets 400mg + Trimethoprim 4577 BP 80mg 4578 Feefen Tablet Ibuprofen BP 200mg P Tablet Uncoated 162/002 Pure pharma Limited, India Sulfadoxine 500mg + POM Tablet Uncoated 162/004 Pure pharma Limited, India Sulphadoxine + Pyrimethamine Pyrimethamine 25mg + Tablets 4579 Artesunate 100mg 4580 Praziquantel Tablets Praziquantel BP 600mg POM Tablet Uncoated 162/006 Pure pharma Limited, India P Tablet Uncoated 162/008 Pure pharma Limited, India Peevaran Tablets Diclofenac Sodium 50mg 4581 4582 Peemox Capsules Amoxicillin 250mg POM Capsule oral 162/009 Pure pharma Limited, India 4583 Indomethacin Capsules Indomethacin 25mg P Capsule oral 162/010 Pure pharma Limited, India 4584 Cloxacillin Capsules Cloxacillin 250mg POM Capsule oral 162/011 Pure pharma Limited, India Betamethasone Dipropionate Betamethasone POM Cream Topical 064/001 R K Sharma, India 4585 Cream 0.05%w/w 4586 Acyclovir Tablets 200mg BP Acyclovir 200mg POM Tablet Uncoated 064/002 R K Sharma, India 4587 Ketoconazole Cream 2% Ketoconazole 2%w/w POM Cream Topical 064/004 R K Sharma, India 4588 Miconazole Cream 2% Miconazole 2%w/w POM Cream Topical 064/005 R K Sharma, India 4589 Acyclovir Cream 5% BP Acyclovir 5%w/w POM Cream Topical 064/006 R K Sharma, India Didanosine Delayed POM Capsule Delayed 112/133 Ranbaxy Laboratories Ltd, India Adosine Dr 250 Capsules 4590 Release USP 250mg Release Didanosine Delayed POM Capsule Delayed 112/134 Ranbaxy Laboratories Ltd, India Adosine Dr 400 Capsules 4591 Release USP 400mg Release Cefpirome Sulphate POM Powder for 112/135 Ranbaxy Laboratories Ltd, India Cefpi 1000 Injection 4592 1000mg Injection Cefpirome Sulphate POM Powder for 112/136 Ranbaxy Laboratories Ltd, India Cefpi 500 Injection 4593 500mg Injection

Page 236 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Solifenacin Succinate POM Tablet Film coated 112/137 Ranbaxy Laboratories Ltd, India Vesizen 5 Tablets 4594 5mg Solifenacin Succinate POM Tablet Film coated 112/138 Ranbaxy Laboratories Ltd, India Vesizen 10 Tablets 4595 10mg Moxifloxacin POM Tablet Film coated 112/139 Ranbaxy Laboratories Ltd, India Staxom Tablets 4596 Hydrochloride 400mg Clove Oil 1% + Mentha POM Solution for Oral 029/001 Raptakos -Brett Company Ltd, India Arvensis 1% + Menthol Use 1% + Chamomile Oil Zytee Mouth Wash 0.15% + Sodium Benzoate 2% + Alcohol 4597 95% GS Powder for Oral 029/002 Raptakos -Brett Company Ltd, India Igol Granules Ispaghula Husk 0.66g 4598 Suspension 4599 Subsyde CR100mg Capsules Diclofenac 100mg POM Tablet Uncoated 029/003 Raptakos -Brett Company Ltd, India 4600 Sucon RB Capsules Vitamins + Minerals GS Capsule oral 029/004 Raptakos -Brett Company Ltd, India GS Suspension for 029/005 Raptakos -Brett Company Ltd, India Sucon RB Suspension Vitamins + Minerals 4601 Oral Use 4602 Duralyn-CR Tablets Theophylline 200mg POM Tablet Uncoated 029/006 Raptakos -Brett Company Ltd, India 4603 Duralyn - CR 400 Capsules Theophylline 400mg POM Capsule oral 029/007 Raptakos -Brett Company Ltd, India 4604 Neogadine Elixir Vitamins + Minerals GS Elixir 029/008 Raptakos -Brett Company Ltd, India Choline Salicylate 9%w/v GS Gel Topical 029/009 Raptakos -Brett Company Ltd, India Zytee RB Gel + Benzokonium Chloride 4605 0.002%w/v Dried Aluminium P Suspension for 029/010 Raptakos -Brett Company Ltd, India Hydroxide 200mg + Oral Use Magnesium Trisilicate 200mg + Magnesium Catoxymag-N Suspension Hydroxide 100mg + Sodium Alginate 100mg + Simethicone 25mg, per 4606 5ml 4607 Durasal 4mg Tablets Salbutamol 4mg POM Tablet Uncoated 029/011 Raptakos -Brett Company Ltd, India Dimethicone 20%w/w + GS Cream Topical 029/012 Raptakos -Brett Company Ltd, India Zinc Oxide 7.5%w/w + Norash Cream Calamine 1.5%w/w + 4608 Cetrimide + 1.125%w/w Tramadol Hydrochloride POM Capsule Sustained 029/013 Raptakos -Brett Company Ltd, India Takol CR 100mg Capsules 4609 100mg Release

Page 237 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Alpha Amylase 100mg + P Capsule oral 029/014 Raptakos -Brett Company Ltd, India Neopeptine Capsules Papain 100mg + 4610 Simethicone 30mg Alpha Amylase 100mg + P Solution for Oral 029/015 Raptakos -Brett Company Ltd, India Neopeptine Liquid 4611 Papain 50mg Use Alpha Amylase 20mg + P Solution for Oral 029/016 Raptakos -Brett Company Ltd, India Neopeptine Drops 4612 Papain 10mg Use Zinc Acetate USP as POM Syrup 029/017 Raptakos -Brett Company Ltd, India Zevac Syrup Dihydrate eq. to 4613 Elemental Zinc 20mg Chloroxylenol 4.8g, per GS Solution for 133/008 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Dettol Antiseptic Liquid 4614 100ml sterilisation SA Amylmetacresol 0.6mg + GS Lozenges 133/009 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Strepsils Eucalyptus Menthol 2,4 Dichlorobenzyl SA Lozenges Alcohol 1.2 Mg + 4615 Lignocaine 10.0mg Amylmetacresol 0.6mg + GS Lozenges 133/010 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Strepsils Orange With Vitamin C 2.4 Dichlorobenzyl SA Lozenges Alcohol 1.2mg + Vitamin 4616 C 100mg Amylmetacresol 0.6mg + GS Lozenges 133/011 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Strepsils Original Lozenges 2,4 Dichlorobenzyl SA 4617 Alcohol 1.2mg, Amylmetacresol 0.6mg + GS Lozenges 133/012 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Strepsils Cool Mint Lozenges 2,4 Dichlorobenzyl SA 4618 Alcohol 1.2mg Ibuprofen 200mg + P Tablet Uncoated 133/013 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Nurofen Cold & Flu Tablets 4619 Pseudoephedrine 30mg SA P Tablet Uncoated 133/014 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Nurofen Tablets Ibuprofen 200mg 4620 SA GS Cream Topical 133/015 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Zinc Undecenoate 5.0g + Mycota Cream 25g SA Undecenoic Acid 1.25g 4621 P Transdermal patch 133/016 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Transact 12 Hour Patches Flurbiprofen 40mg 4622 SA P Tablet Film coated 133/017 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Senokot Tablets Sennoside B 7.5mg 4623 SA

Page 238 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER P Lozenges 133/018 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Amylmetacresol 0.6mg + Strepsils Plus, Anaesthetic SA 2.4 Dichlorobenzyl 1.2mg lozenges + Lignocaine 10.0mg 4624 Strepsils Intensive lozenges P Lozenges 133/019 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Flurbiprofen 8.75mg 4625 (Honey & Lemon) SA Flurbiprofen Sodium P Lozenges 133/020 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Strepsils Intensive Lozenges 4626 8.75mg SA Nurofen For Children Strawberry Ibuprofen 2% w/v P Solution for Oral 133/021 Reckitt Benckiser Pharmaceutical (Pty) Ltd, 4627 Suspension (100mg, per 5ml) Use SA Nurofen For Children Sugar P Syrup 133/022 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Ibuprofen 100mg, per 5ml 4628 Free Syrup SA Nurofen 400 Period Pain P Tablet Film coated 133/023 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Ibuprofen 400mg 4629 Tablets SA Sodium Alginate 500mg GS Suspension for 133/024 Reckitt Benckiser Pharmaceutical (Pty) Ltd, + Sodium Bicarbonate Oral Use SA Gaviscon Double Action Liquid 213mg + Calcium 4630 Carbonate 325mg Sodium Alginate 250mg GS Tablet Uncoated 133/025 Reckitt Benckiser Pharmaceutical (Pty) Ltd, + Sodium Bicarbonate SA Gaviscon Double Action Tablet 106.05mg + Calcium 4631 Carbonate 187.50mg Nurofen Maximum Strength 684 P Tablet Film coated 133/026 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Ibuprofen Lysin 684mg 4632 Caplets SA Nurofen Tension Headache 342 P Tablet Film coated 133/027 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Ibuprofen Lysin 342mg 4633 Caplets SA Nurofen Express 400 Liquid P Capsule, Soft 133/028 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Ibuprofen 400mg 4634 Capsules SA Sodium Alginate 500mg GS Suspension for 133/029 Reckitt Benckiser Pharmaceutical (Pty) Ltd, Gaviscon Double Action Liquid + Sodium Bicarbonate Oral Use SA Sachets 213mg + Calcium 4635 Carbonate 325mg E45 Cream White Paraffin 14.5g GS 133/035L Reckitt Benckiser Pharmaceutical (Pty) Ltd, +Light Paraffin 12.6g + SA 4636 Anhydrous Lanol GS Tablets Uncoated 133/001 Reckitt Benkiser Pharmaceuticals S.A.(Pty) Disprin 300mg Tablets Aspirin 300mg 4637 Ltd, South Africa GS Tablets Uncoated 133/002 Reckitt Benkiser Pharmaceuticals S.A.(Pty) Disprin 500mg Tablets Aspirin 500mg 4638 Ltd, South Africa

Page 239 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Zinc Undecenoate 20% GS Powder Topical 133/003 Reckitt Benkiser Pharmaceuticals S.A.(Pty) Mycota Powder 4639 w/w Ltd, South Africa Alginic Acid 500 + GS Suspension for 133/004 Reckitt Benkiser Pharmaceuticals S.A.(Pty) Sodium Bicarbonate Oral Use Ltd, South Africa Gaviscon Tablets 213mg + Calcium 4640 Carbonate 325.0mg Sodium Algnite 500mg + GS Suspension for 133/005 Reckitt Benkiser Pharmaceuticals S.A.(Pty) Sodium Hydrogen Oral Use Ltd, South Africa Gaviscon Original Aniceed Carbonate 213mg + Calcium Carbonate 4641 325mg Sodium Algnite 500mg + GS Suspension for 133/006 Reckitt Benkiser Pharmaceuticals S.A.(Pty) Sodium Hydrogen Oral Use Ltd, South Africa Gaviscon Peppermint Liquid Carbonate 213mg + Calcium Carbonate 4642 325mg Centalkonium Chloride GS Gel Topical 133/007 Reckitt Benkiser Pharmaceuticals S.A.(Pty) Bonjela Clear Gel 0.010% w/w + Choline Ltd, South Africa 4643 Salicylate 8.714 % w/w Diphenhydramine P Syrup 205/001 Regal Pharmaceuticals Limited,Kenya Hydrochloride BP 14mg + Ammonium Chloride BP Delased Chesty Syrup 135mg + Sodium Citrate BP 57mg + Menthol 4644 1.1mg, per 5ml. Menthol 2mg + Sodium P Syrup 205/002 Regal Pharmaceuticals Limited,Kenya Citrate 57mg + Delased Dry Syrup Dextrometherphan 6.5mg + Diphenhydramine 4645 14mg Chlorpheniramine P Syrup 205/003 Regal Pharmaceuticals Limited,Kenya Maleate BP 2mg + Pseudoephedrine Coldcap Syrup Hydrochloride BP 10mg + Paracetamol BP 120mg, 4646 per 5ml.

Page 240 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Diphenhydramine P Syrup 205/004 Regal Pharmaceuticals Limited,Kenya Hydrochloride BP 7mg + Delased Peadiatric Syrup Sodium Citrate BP 28.5mg + Menthol BP 4647 0.55mg, per 5ml. Phenylephrine 30mg + P Capsule oral 205/005 Regal Pharmaceuticals Limited,Kenya Caffeine 30mg + Coldcap Capsules Paracetamol 100mg + 4648 Chlorpheniramine 4mg Salicylic Acid 30mg + P Ointment topical 205/006 Regal Pharmaceuticals Limited,Kenya Whitfield Ointment 4649 Benzoic Acid 60mg 4650 Rinavit Syrup Multivitamins GS Syrup 205/007 Regal Pharmaceuticals Limited,Kenya P Suspension for 205/008 Regal Pharmaceuticals Limited,Kenya Ibumex Suspension Ibuprofen 100mg, per 5ml 4651 Oral Use Chlorpheniramine P Syrup 205/009 Regal Pharmaceuticals Limited,Kenya Rinalin Syrup 4652 2mg/5ml 4653 Megayl - 200 Tablets Metronidazole 200mg POM Tablet Uncoated 205/010 Regal Pharmaceuticals Limited,Kenya Paracetamol 120mg, per GS Syrup 205/011 Regal Pharmaceuticals Limited,Kenya Cetamol Syrup 4654 5ml 4655 Salbutamol Syrup Salbutamol 2mg, per 5ml POM Syrup 205/012 Regal Pharmaceuticals Limited,Kenya Aluminium Hydrochloride GS Tablet Uncoated 205/013 Regal Pharmaceuticals Limited,Kenya Compound Magnesium Tablets 125mg + Magnesium 4656 Trisilicate 250mg White Soft Paraffin + P Cream Topical 205/014 Regal Pharmaceuticals Limited,Kenya Ruben Cream Methyl Salicylate + 4657 Capsicum Oleoresin 4658 Cetanol Tablets Paracetamol 500mg GS Tablet Uncoated 205/015 Regal Pharmaceuticals Limited,Kenya Salbutamol 2mg + P Syrup 205/016 Regal Pharmaceuticals Limited,Kenya Trimex Mucolytic Syrup Bromhexine 4mg + 4659 Guanfenesin 100mg 4660 Ibumex Tablets Ibuprofen 200mg P Tablet Uncoated 205/017 Regal Pharmaceuticals Limited,Kenya 4661 Intamine Cream Mepyramine 20mg P Cream Topical 205/018 Regal Pharmaceuticals Limited,Kenya Aluminium Hydrochloride GS Suspension for 205/019 Regal Pharmaceuticals Limited,Kenya Magnomint Suspension 250mg + Magnesium Oral Use 4662 Trisilicate 250mg Nicotinamide 15mg + P Tablet Film coated 205/020 Regal Pharmaceuticals Limited,Kenya Riboflavin 1mg + Intaplex Tablets Thiamine Hydrochloride 4663 1mg

Page 241 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Amoxicilin Trihydrate Bp POM Powder for Oral 205/021 Regal Pharmaceuticals Limited,Kenya Unixil Oral Suspension 4664 125mg, per 5ml Suspension TrastuRel 150 Injection Trastuzumab 150mg POM Solution for 451/001 Reliance Life Sciences Pvt Ltd 4665 infusion TrastuRel 440 Injection Trastuzumab 440mg POM Solution for 451/002 Reliance Life Sciences Pvt Ltd 4666 Injection 4667 Cilox Tablets Ofloxacin 200mg POM Tablet Film coated 209/001 Remedica Ltd, Cyprus 4668 Alfoxan 250 Capsules Mefenamic Acid 250mg P Capsule oral 209/002 Remedica Ltd, Cyprus 4669 Cyclovax 200 Tablets Acylovir 200mg POM Tablet Film coated 209/003 Remedica Ltd, Cyprus 4670 Ibuprofen Tablets Ibuprofen 200mg P Tablet Film coated 209/004 Remedica Ltd, Cyprus 4671 Korandil 10 Tablets Enalapril 10mg POM Tablet Uncoated 209/005 Remedica Ltd, Cyprus 4672 Nifelat Sr Tablets Nifedipine 20mg POM Tablet Film coated 209/006 Remedica Ltd, Cyprus 4673 Nifelat 10 Tablets Nifedipine 10mg POM Tablet Film coated 209/007 Remedica Ltd, Cyprus 4674 Ova-Mit 50 Tablets Clomifene 50mg POM Tablet Film coated 209/008 Remedica Ltd, Cyprus 4675 Remethan 25 Tablets Diclofenac 25mg P Tablet Film coated 209/009 Remedica Ltd, Cyprus 4676 Roxitan 10 Capsules Piroxicam 10mg POM Capsule oral 209/010 Remedica Ltd, Cyprus 4677 Zindolin 250 Tablets Ciprofloxacin 250mg POM Tablet Film coated 209/011 Remedica Ltd, Cyprus Calcium 1200mg + P Tablet Uncoated 367/001L Robinson Pharma, INC Calcium + Vitamin D Tablets 4678 Vitamin D 3600IU 4679 Garlic Oil Soft Gels Garlic Oil 5000mg P Capsule oral 367/002L Robinson Pharma, INC Calcium 110mg + Multi- P Tablet Uncoated 367/003L Robinson Pharma, INC Multi-Enzyme Complete Tablets 4680 Enzyme Blend 430mg 4681 Co-Enzyme Q10 Softgels Co-Enzyme Q10 50mg P Capsule oral 367/004L Robinson Pharma, INC 4682 Women Once A Day Tablets Multivitamins & Minerals P Tablet Uncoated 367/005L Robinson Pharma, INC Calcium Carbinate P Tablet Uncoated 367/006L Robinson Pharma, INC 150mg + Alpha Lipoic Acetyl L - Carnitine Tablets Acid 200mg + Acetyl L 4683 Carnitine 500mg Green Tea Extract P Capsule oral 367/007L Robinson Pharma, INC Green Tea Extract Softgels 4684 320mg Vitamin D 200iu + P Capsule oral 367/008L Robinson Pharma, INC Liquid Absorbable Calcium Calcium Carbonate Softgels 4685 1000mg 4686 Beta Carotene Softgels Vitamin A 25000IU P Capsule oral 367/009L Robinson Pharma, INC 4687 Men Daily Tablets Multivitamins & Minerals P Tablet Uncoated 367/010L Robinson Pharma, INC 4688 Saw Palmetto 450 Capsules Saw Palmetto 450mg P Capsule oral 367/011L Robinson Pharma, INC 4689 Super B Complex Capsules Vitamin B Complex P Capsule oral 367/012L Robinson Pharma, INC 4690 Aloe Vera 25 Softgels Aloe Vera 25mg P Capsule oral 367/013L Robinson Pharma, INC

Page 242 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Glucosamine Sulphate 1000 Glucosamine Sulphate P Capsule oral 367/014L Robinson Pharma, INC 4691 Capsules 1000mg 4692 Melatonin 5 Tablets Melatonin 5mg P Tablet Uncoated 367/015L Robinson Pharma, INC 4693 Vitamin D 2000IU Softgel Vitamin D 2000IU P Capsule oral 367/016L Robinson Pharma, INC Resveratrol Complex P Capsule oral 367/017L Robinson Pharma, INC Resveratrol Complex Capsules 4694 260mg Nelbuphine POM Solution for 359/001 RUSAN PHARMA LIMITED Rubuphine 10 Injection 4695 Hydrochloride 10mg Injection Nelbuphine POM Solution for 359/002 RUSAN PHARMA LIMITED Rubuphine 20 Injection 4696 Hydrochloride 20mg Injection Telmisartan 20mg + POM Tablet Uncoated 354/001 S3K Private Limited, India BP -Care Tablets 4697 Amlodipine 2.5mg Telmisartan 40mg + POM Tablet Uncoated 354/002 S3K Private Limited, India BP-Care Tablets 4698 Amlodipine 5mg Glimepiride 2mg + POM Tablet Film coated 354/003 S3K Private Limited, India GM - Pride Tablets Metformin Hydrochloride 4699 500mg POM Tablet Enteric 354/004 S3K Private Limited, India Safecoat Aspirin 75mg Tablets Aspirin 75mg 4700 Coated 4701 Moxypen Capsules Amoxicillin BP 250mg POM Capsule oral 032/001 SADM Pharmaceuticals Ltd, Malawi 4702 Puromylon Tablets Nalidixic Acid 500mg POM Tablet Uncoated 032/002 SADM Pharmaceuticals Ltd, Malawi 4703 Trichozole Tablets Metronidazole 200mg POM Tablet Uncoated 032/003 SADM Pharmaceuticals Ltd, Malawi Phenoxymethyl Penicillin POM Tablet Uncoated 032/004 SADM Pharmaceuticals Ltd, Malawi Len VK Tablets 4704 BP 250mg POM Capsule oral 032/005 SADM Pharmaceuticals Ltd, Malawi Doxycycline Doxycline Capsules Hydrochloride BP 100mg 4705 POM Tablet Enteric 032/006 SADM Pharmaceuticals Ltd, Malawi Quinine Tablets Quinine Sulphate 300mg 4706 Coated 4707 Pertecillin Capsules Ampicillin 250mg POM Tablet Uncoated 032/007 SADM Pharmaceuticals Ltd, Malawi Sulphamethoxazole POM Tablet Uncoated 249/001 Saga Laboratories, India Trimaprim Tablets 400mg + Trimethoprim 4708 80mg 4709 Flamcid Capsules Indomethacin BP 25mg P Capsule oral 249/002 Saga Laboratories, India Cephalexin Anhydrous POM Capsule oral 249/003 Saga Laboratories, India Safexin 500mg Capsules 4710 BP 500mg Ciprofloxacin USP POM Tablet Uncoated 249/004 Saga Laboratories, India Q-Bact Tablets 4711 500mg 4712 Rufen 200 Tablets Ibuprofen 200mg P Tablet Uncoated 249/005 Saga Laboratories, India

Page 243 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Erythromycin Estolate BP POM Tablet Uncoated 249/006 Saga Laboratories, India Rythrocine Tablets 4713 250mg 4714 Omecid Capsules Omeprazole 20mg POM Capsule oral 249/007 Saga Laboratories, India 4715 Finapril Tablets Enalapril Maleate 20mg POM Tablet Uncoated 249/008 Saga Laboratories, India 4716 Finapril Tablets Enalapril 10mg POM Tablet Uncoated 249/009 Saga Laboratories, India 4717 Finapril Tablets Enalapril 5mg POM Tablet Uncoated 249/010 Saga Laboratories, India POM Tablet Uncoated 249/011 Saga Laboratories, India Hexantel Tablets Pyrantel Pamoate 125mg 4718 4719 Eze DT Tablets Cetirizine 10mg POM Tablet Uncoated 249/012 Saga Laboratories, India 4720 Antipress 100 Tablets Atenolol 100mg POM Tablet Uncoated 249/013 Saga Laboratories, India 4721 Antipress 50 Tablets Atenolol 50mg POM Tablet Uncoated 249/014 Saga Laboratories, India 4722 Nifetab 10 Tablets Nifedipine 10mg POM Tablet Uncoated 249/015 Saga Laboratories, India POM Tablet extended 249/016 Saga Laboratories, India Nifetab 20 Tablets Nifedipine 20mg 4723 release 4724 Vitarich Tablets Multivitamins + Minerals POM Tablet Uncoated 249/017 Saga Laboratories, India 4725 Allerban Tablets Loratadine 10mg POM Tablet Uncoated 249/018 Saga Laboratories, India 4726 Pyranim Tablets Nimesulide 100mg POM Tablet Uncoated 249/019 Saga Laboratories, India 4727 Piroximicam Tablets Piroxicam 20mg POM Tablet Uncoated 249/020 Saga Laboratories, India Metronidazole 100mg + POM Suspension for 249/021 Saga Laboratories, India Diarid Suspension Norfloxacin 100mg, per Oral Use 4728 5ml Vitamin A,C,E With P Tablet Uncoated 249/022 Saga Laboratories, India ACE Selenium Tablets 4729 Selenium Metronidazole 100mg + POM Suspension for 249/023 Saga Laboratories, India Diarest Suspension Furazolidone 30mg, per Oral Use 4730 5ml Ambroxol 15mg + POM Syrup 249/024 Saga Laboratories, India Salbutamol Sulphate 1mg Airmax -Plus Syrup + Guaphenesin 50mg + 4731 Menthol 1mg GS Solution for Oral 249/025 Saga Laboratories, India Abvit Drops Multivitamins 4732 Use Paracetamol 125mg + P Suspension for 249/026 Saga Laboratories, India Phenylephrine 2.5mg + Oral Use Lamoryl Suspension Chlopheniramine Maleate 4733 1mg, per 5ml Caffeine 30mg + P Capsule oral 249/027 Saga Laboratories, India Iburex Capsules Paracetamol 325mg + 4734 Ibuprofen 200mg

Page 244 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER POM Suspension for 249/028 Saga Laboratories, India Hexantel Suspension Pyrantel Pamoate 250mg 4735 Oral Use Lorsartan Potassium POM Tablet Uncoated 249/029 Saga Laboratories, India Lotenz Tablets 4736 50mg Lorsartan Potassium POM Tablet Uncoated 249/030 Saga Laboratories, India 50mg + Lotenz-H Hydrochlorothiazide 4737 12.5mg POM Powder for 401/001 Sakar Health Care Pvt India Sefixi Injection Ceftriaxone 1g 4738 Injection POM Powder for 401/002 Sakar Health Care Pvt India Samero Meropenem 1g 4739 Injection Impenem 500mg + POM Powder for 401/003 Sakar Health Care Pvt India Silpen -1000 Injection 4740 Cilastatin 500mg Injection Dihydroartemisinin 40mg POM Tablet Uncoated 350/001 Salvat, SA Malacur Tablets + Piperaquine Phosphate 4741 320mg POM Powder for Oral 350/002 Salvat, SA Dihydroartemisinin 90mg Malacur Powder For Oral Suspension + Piperaquine Phosphate Suspension 720mg, per 60ml 4742 Clindamycin POM Capsule oral 039/033 Sandoz (SA) Limited Clindahexal 150 Capsules 4743 Hydrochloride 150mg Rifampicin BP150mg / Isoniazid Rifampicin 150mg + POM Tablet Uncoated 308/001 Sandoz Private Limited,India 4744 BP 75mg Isoniazid 75mg Rifampicin + Isoniazide + POM Tablet Uncoated 308/002 Sandoz Private Limited,India Pyrazinamide + Rimstar -4-FDC Tablets Ethambutol 4745 Hydrochloride p Tablet Effervescent 039/001 Sandoz Pvt Limited, S.A ACC 200 Effevescent Tablets n- Acetylcysteine 200mg 4746 P Tablet Effervescent 039/002 Sandoz Pvt Limited, S.A ACC 600 Effervescent Tablets n- Acetylcysteine 600mg 4747 POM Powder for 039/003 Sandoz Pvt Limited, S.A Clatax 0.5g Injection Cefotaxime 0.5g 4748 Injection POM Powder for 039/004 Sandoz Pvt Limited, S.A Clatax 1.0g Injection Cefotaxime 1.0g 4749 Injection POM Powder for 039/005 Sandoz Pvt Limited, S.A Kefzol 500 Powder for Injection Cefazolin 500mg 4750 Injection

Page 245 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER POM Powder for 039/006 Sandoz Pvt Limited, S.A Kefzol 1g Powder for Injection Cefazolin 1g 4751 Injection POM Tablet Effervescent 039/007 Sandoz Pvt Limited, S.A Lopedium Effevescent Tablets Loperamide 2mg 4752 Sandoz Co Amoxyclav 0.6g Amoxycillin 500mg + POM Powder for 039/008 Sandoz Pvt Limited, S.A 4753 /20ml Injection Clavulanate 100mg Injection Sandoz Co Amoxyclav Amoxycillin 1000mg + POM Powder for 039/009 Sandoz Pvt Limited, S.A 4754 1.2g/20ml Injection Clavulanate 200mg Injection Sandoz Co Amoxyclav 625mg Amoxicillin 500mg + POM Tablet Film coated 039/011 Sandoz Pvt Limited, S.A 4755 Tablets Clavulanate 125mg Sandoz Co Amoxuclav 1000 Amoxycillin 875mg + POM Tablet Film coated 039/012 Sandoz Pvt Limited, S.A 4756 Tablets Clavulanate 125mg Sandoz Co Amoxyclav BD Amoxycillin 400mg + POM Powder for Oral 039/013 Sandoz Pvt Limited, S.A 4757 Suspension Clavulanate 57mg Suspension Sandoz Co Amoxyclav S Amoxycillin 125mg + POM Powder for Oral 039/014 Sandoz Pvt Limited, S.A 4758 Suspension Clavulanate 31.25mg Suspension Amoxycillin 250mg + POM Powder for Oral 039/015 Sandoz Pvt Limited, S.A Sandoz Co- Amoxyclav SF Clavulanate 62.5mg, per Suspension Suspension 4759 5ml Sandoz Carbamezapine CR 200 POM Tablet delayed 039/016 Sandoz Pvt Limited, S.A Carbamezapine 200mg 4760 Tablets Release Sandoz Carbamezapine CR POM Tablet delayed 039/017 Sandoz Pvt Limited, S.A Carbamezapine 400mg 4761 400mg Tablets Release 4762 Tramhexal Capsules Tramadol 50mg POM Capsule oral 039/018 Sandoz Pvt Limited, S.A POM Solution for 039/019 Sandoz Pvt Limited, S.A Tramhexal 100mg/2ml Injections Tramadol 100mg per 2ml 4763 Injection 4764 Sandoz Atorvastatin 10 Tablets Atorvastalin 10mg POM Tablet Uncoated 039/020 Sandoz Pvt Limited, S.A 4765 Sandoz Atorvastatin 20 Tablets Atorvastalin 20mg POM Tablet Uncoated 039/021 Sandoz Pvt Limited, S.A 4766 Sandoz Atorvastatin 40 Tablets Atorvastalin 40mg POM Tablet Uncoated 039/022 Sandoz Pvt Limited, S.A 4767 Sandoz Atorvastatin 80 Tablets Atorvastalin 80mg POM Tablet Uncoated 039/023 Sandoz Pvt Limited, S.A Medroxyprogesterone POM Tablet Uncoated 039/026 Sandoz Pvt Limited, S.A Hexal - MPA 10 Tablets 4768 10mg Medroxyprogesterone POM Tablet Uncoated 039/027 Sandoz Pvt Limited, S.A Hexal - MPA 5 Tablets 4769 5mg 4770 Terbane 250mg Tablets Terbinafine 250mg POM Tablet Uncoated 039/028 Sandoz Pvt Limited, S.A 4771 Terbane 10mg Cream Terbinafine 10mg POM Cream Topical 039/029 Sandoz Pvt Limited, S.A

Page 246 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Lorsartan Potassium POM Tablet Uncoated 039/031 Sandoz Pvt Limited, S.A 100mg + Los -Arb Comp 100 Tablets Hydrochlorothiazide 4772 25mg Lorsartan Potassium POM Tablet Uncoated 039/032 Sandoz Pvt Limited, S.A 50mg + Los -Arb Comp 50 Tablets Hydrochlorothiazide 4773 12.5mg Capectabine Sandoz 500 Film POM Tablet Film coated 039/034 Sandoz Pvt Limited, S.A Capacetabine 500mg 4774 Coated Tablets Capectabine Sandoz 150 Film POM Tablet Film coated 039/035 Sandoz Pvt Limited, S.A Capacetabine 150mg 4775 Coated Tablets POM Tablet Modified 039/036 Sandoz Pvt Limited, S.A Epipro 300 CR Tablets Sodium Valproate 300mg 4776 Release POM Tablet Modified 039/037 Sandoz Pvt Limited, S.A Epipro 500 CR Tablets Sodium Valproate 500mg 4777 Release Gentamycin 80mg per 2ml Gentamycin Suliphate POM Solution for 039/038 Sandoz Pvt Limited, S.A 4778 Injection 80mg per 2ml Injection 4779 Hexal - Lisinopril 5 Tablets Lisinopril Dihydrate 5mg POM Tablet Uncoated 039/039 Sandoz Pvt Limited, S.A POM Tablet Uncoated 039/040 Sandoz Pvt Limited, S.A Hexal - Lisinopril 10 Tabletrs Lisinopril Dihydrate 10mg 4780 POM Tablet Uncoated 039/041 Sandoz Pvt Limited, S.A Hexal - Lisinopril 20 Tablets Lisinopril Dihydrate 20mg 4781 4782 HR-Enalapril Maleate 5 Tablets Enalapril Maleate 5mg POM Tablet Uncoated 039/042 Sandoz Pvt Limited, S.A POM Tablet Uncoated 039/043 Sandoz Pvt Limited, S.A HR-Enalapril Maleate 10 Tablets Enalapril Maleate 10mg 4783 POM Tablet Uncoated 039/044 Sandoz Pvt Limited, S.A HR-Enalapril Maleate 20 Tablets Enalapril Maleate 20mg 4784 4785 Pixicam 20 Tablets Piroxicam 20mg P Tablet Uncoated 039/045 Sandoz Pvt Limited, S.A Vancomycin POM Powder for 039/046 Sandoz Pvt Limited, S.A Vancocin CP 1g Injection 4786 Hydrochloride 1g Injection Vancomycin POM Powder for 039/047 Sandoz Pvt Limited, S.A Vancocin CP 500 Injection 4787 Hydrochloride 500mg Injection 4788 Zomevak 80 Tablets Valsartan 80mg POM Tablet Uncoated 039/048 Sandoz Pvt Limited, S.A 4789 Zomevak 160 Tablets Valsartan 160mg POM Tablet Uncoated 039/049 Sandoz Pvt Limited, S.A Sandoz Levofloxacin 500 Levofloxacin POM Tablet Film coated 039/050 Sandoz Pvt Limited, S.A 4790 Tablets Hemihydrate 500mg Sandoz Isosorbide Dinitrate 30 Isorsorbide Dinitrate POM Tablet Uncoated 039/051 Sandoz Pvt Limited, S.A 4791 Tablets 30mg

Page 247 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER P Solution for Oral 039/052 Sandoz Pvt Limited, S.A Cetirizine Dihydrochloride Cetirizine HEXAL -1 Syrup Use 10mg per 5ml 4792 Cetirizine Hydrochloride P Solution for Oral 039/053 Sandoz Pvt Limited, S.A Cetirizine Hexal 10 Tablets 4793 10mg Use Ondansetron POM Solution for 039/054 Sandoz Pvt Limited, S.A Dantron 4mg Injection 4794 Hydrochloride 4mg Injection Ondansetron POM Solution for 039/055 Sandoz Pvt Limited, S.A Dantron 8mg Injection Hydrochloride Dihydrate infusion 4795 8mg Ondansetron POM Tablet Uncoated 039/056 Sandoz Pvt Limited, S.A Dantron 4mg Tablets Hydrochloride Dihydrate 4796 4mg Doxorubicin POM Solution for 039/057 Sandoz Pvt Limited, S.A Doxorubicin Hexal 10mg/5ml Hydrochloride 10mg, per infusion Infusion 4797 5ml Sandoz Isorsobide Dinitrate 5 POM Tablet Sublingual 039/058 Sandoz Pvt Limited, S.A Isorsobide Dinitrate 5 Mg 4798 Sublingual Tablet Sandoz Isorsobide Dinitrate 30 Isorsobide Dinitrate 30 POM Tablet Uncoated 039/059 Sandoz Pvt Limited, S.A 4799 Tablet Mg Doxorubicin POM Solution for 039/060 Sandoz Pvt Limited, S.A Doxorubicin Hexal 50mg, per Hydrochloride 50mg, per infusion 25ml Infusion 4800 25ml 4801 Lorano Tablets Loratadine 10mg P Tablet Uncoated 039/061 Sandoz Pvt Limited, S.A Beclomethasone POM Solution for 039/062 Sandoz Pvt Limited, S.A Clenil AQ Nasal Spray 4802 Dipropionate 50mcg Inhalation POM Tablet Uncoated 039/063 Sandoz Pvt Limited, S.A Clomihexal Tablets Clomiphene Citrate 50mg 4803 4804 Oxiceb 100 Mg Capsules Celecoxib 100mg POM Capsules oral 039/084 Sandoz Pvt Limited, S.A 4805 Oxiceb 200 Mg Capsules Celecoxib 200mg POM Capsules oral 039/085 Sandoz Pvt Limited, S.A Salmeterol Xinafoate POM Inhaler 039/086 Sandoz Pvt Limited, S.A Airflusal Forspiro 50µg + Fluticasone 4806 Propionate 250µg Salmeterol Xinafoate POM Inhaler 039/087 Sandoz Pvt Limited, S.A Airflusal Forspiro 50mcg + Fluticasone 4807 Propionate 500mcg POM Inhaler 039/088 Sandoz Pvt Limited, S.A Salbutamol Sandoz 100 µg, per Salbutamol 100 µg, per Dose Pressurised Inhalation Dose 4808

Page 248 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Mometasone Furoate POM Inhaler 039/089 Sandoz Pvt Limited, S.A Mometasone Sandoz 50 Monohydrate 50mg, per 1 4809 Dose Metformin 1000 Film Coated Metformin Hydrochloride POM Tablet Film coated 039/090 Sandoz Pvt Limited, S.A 4810 Tablets 1000mg Metformin 500 Film Coated Metformin Hydrochloride POM Tablet Film coated 039/091 Sandoz Pvt Limited, S.A 4811 Tablets 500mg Anastrozole Sandoz 1mg POM Tablet Film coated 039/092 Sandoz Pvt Limited, S.A Anastrozole 1mg 4812 Tablets 4813 Fenahex 20 mg Tamoxifen Citrate 20 mg POM Tablet Uncoated 039/093 Sandoz Pvt Limited, S.A 4814 Simvastatin 20 mg Simvastatin 20 mg POM Tablet Film coated 039/094 Sandoz Pvt Limited, S.A 4815 Simvastatin 40 mg Simvastatin 40 mg POM Tablet Film coated 039/095 Sandoz Pvt Limited, S.A Amoxicillin Trihydrate POM Tablet Uncoated 039/096 Sandoz Pvt Limited, S.A Ospamox 1000 Tablets 4816 1000mg 4817 Ospamox 500 Tablets Amoxicillin 500mg POM Tablet Uncoated 039/097 Sandoz Pvt Limited, S.A POM Tablet Uncoated 039/098 Sandoz Pvt Limited, S.A Voriconazole Sandoz 50 Tablets Voriconazole 50mg 4818 4819 Nexmezol 20 Esomeprazole 20mg POM Tablet Uncoated 039/099 Sandoz Pvt Limited, S.A 4820 Nexmezol 40 Esomeprazole 40mg POM Tablet Uncoated 039/100 Sandoz Pvt Limited, S.A 4821 Deslatyne 5 Tablets Desloratidine 5mg POM Tablet Uncoated 039/101 Sandoz Pvt Limited, S.A 4822 Furose 40 Tablets Frusemide 40mg POM Tabet Uncoated 039/102 Sandoz Pvt Limited, S.A Pantoprazole Sodium POM Solution for 039/103 Sandoz Pvt Limited, S.A Topraflux 40 IVI Injection 4823 Sesquihydrate BP 40mg Injection 4824 Amlodipine 5 mg Amlodipine 5 mg POM Tablet Uncoated 039/104 Sandoz Pvt Limited, S.A 4825 Amlodipine 10 mg Amlodipine 10 mg POM Tablet Uncoated 039/105 Sandoz Pvt Limited, S.A Sandaz Azithromycin 500 POM 039/106 Azithromycin 500mg Tablet Uncoated Sandoz Pvt Limited, S.A 4826 Tablets POM Solution for Oral 039/107 Azithromycin 200 Sandoz Syrup Azithromycin 200mg Sandoz Pvt Limited, S.A 4827 Use Voriconazole Sandoz 200 POM Tablet Film Coated 039/108 Voriconazole 200mg Sandoz Pvt Limited, S.A 4828 Tablets Sandoz Co Amoxyclav 375 Amoxycillin 250mg + POM Tablet Film coated 039/010 Sandoz Pvt Limited, South Africa 4829 Tablets Clavulanate 125mg 4830 Bisohexal 10 Tablets Bisoprolol 10mg POM Tablet Uncoated 039/024 Sandoz Pvt Limited, South Africa 4831 Bisohexal 5 Tablets Bisoprolol 5mg POM Tablet Uncoated 039/025 Sandoz Pvt Limited, South Africa Montelukast Sodium BP POM Tablet Chewable 039/064 Sandoz Pvt Limited, South Africa Sintrine 5 Chewable Tablets 4832 5mg Montelukast Sodium BP POM Tablet Chewable 039/065 Sandoz Pvt Limited, South Africa Sintrine 10 Chewable Tablets 4833 10mg

Page 249 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Ondansetron POM Tablet Uncoated 039/066 Sandoz Pvt Limited, South Africa Dantron 8 Tablets Hydrochloride Dihydrate 4834 8mg Hydrochlorothiazide POM Tablet Film coated 039/067 Sandoz Pvt Limited, South Africa Hexaide 25mg Tablets 4835 25mg 4836 Coughspan Dried Ivy Leaves 0.9g P Syrup 039/068 Sandoz Pvt Limited, South Africa Piperacilline 4g + POM Powder for 039/069 Sandoz Pvt Limited, South Africa Curitaz 4,5 Infusion Powder 4837 Tozobactam 0.5g Injection Bifidobacterium Animalis P Capsule oral 039/070 Sandoz Pvt Limited, South Africa Linex Capsules 4838 Sub Spp. 280mg Bifidobacterium Animalis P Granules for 039/071 Sandoz Pvt Limited, South Africa Linex Baby Sachets 4839 Sub Spp. 100mg Suspension Gemcitabine POM Solution for 039/076 Sandoz Pvt Limited, South Africa Gemcitabine Ebewe Injection Hydrochloride 10mg, per Injection 4840 ml 4841 Probitor 40 Capsules Omeprazole 40mg POM Capsule oral 039/077 Sandoz Pvt Limited, South Africa Sandoz - Isosorbide Dinitrate 5 POM Tablet Sublingual 039/078 Sandoz Pvt Limited, South Africa Isorsorbide Dinitrate 5mg 4842 Sublingual Tablets Sandoz Isosorbide dinitrate 10 Isorsorbide Dinitrate POM Tablet Uncoated 039/079 Sandoz Pvt Limited, South Africa 4843 tablets 10mg Levofloxacin POM Tablet Film coated 039/080 Sandoz Pvt Limited, South Africa Sandoz Levofloxacin 250 tablets 4844 Hemihydrate 250mg 4845 Bromaze 6 tablets Bromazepam 6mg POM Tablet Uncoated 039/081 Sandoz Pvt Limited, South Africa Bacitracin Zinc 5000IU + POM Powder for Topical 039/082 Sandoz Pvt Limited, South Africa Bacitracin Zinc + Neomycin Neomycin Sulphate use Sulphate 4846 250mg Paracetamol 500mg + P Powder for Oral 039/083 Sandoz Pvt Limited, South Africa Dozalgic C Sachets 4847 Ascorbic Acid 300mg Solution Retarpen 0.6 Injection Benzathine POM Powder for 039/118 Sandoz Pvt Limited, South Africa BenzylPenicillin Injection 4848 600,000IU Retarpen 2.4 Injection Benzathine POM Powder for 039/120 Sandoz Pvt Limited, South Africa Benzylpenicillin Ph. Eur. Injection 4849 2,400,000 IU Retarpen 1.2 Injection Benzathine POM Powder for 039/119 Sandoz Pvt Limited, South Africa BenzylPenicillin Injection 4850 1,200,000IU 4851 Phenergan 10mg Tablets Promethazine 10mg P Tablets 175/001 Sanofi Aventis Pharma Limited 4852 Phenergan 25 Tablets Promethazine 25mg P Tablet Film coated 175/002 Sanofi Aventis Pharma Limited

Page 250 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Promethazine 5mg, per P Elixir 175/003 Sanofi Aventis Pharma Limited Phenergan Elixir 4853 5ml 4854 Tritace 5 Tablets Ramipril 5mg POM Tablet Uncoated 175/004 Sanofi Aventis Pharma Limited 4855 Tritace 2.5 Tablets Ramipril 2.5mg POM Tablet Uncoated 175/005 Sanofi Aventis Pharma Limited 4856 Largactil 100mg Tablets Chlorpromazine 100mg POM Tablet Uncoated 175/006 Sanofi Aventis Pharma Limited Chlorpromazine 50mg, POM Solution for 175/007 Sanofi Aventis Pharma Limited Largactil Injection 4857 per 2ml Injection 4858 Largactil 25 Tablets Chlorpromazine 25mg POM Tablet Film coated 175/008 Sanofi Aventis Pharma Limited Prochlorperazine POM Solution for 175/009 Sanofi Aventis Pharma Limited Stemetil Injection 4859 Mesylate 12.5mg, per ml Injection Prochloperazine POM Tablet Uncoated 175/010 Sanofi Aventis Pharma Limited Stemitil 5 Tablets 4860 Mesylate BP 5mg 4861 Flagyl Suppository Metronidazole 1g POM Suppository 175/011 Sanofi Aventis Pharma Limited 4862 Flagyl 400 Tablets Metronidazole 400mg POM Tablet Uncoated 175/012 Sanofi Aventis Pharma Limited 4863 Flagyl 200 Tablets Metronidazole 200mg POM Tablet Uncoated 175/013 Sanofi Aventis Pharma Limited 4864 Amaryl 4 Tablets Glimepiride 4mg POM Tablet Uncoated 175/014 Sanofi Aventis Pharma Limited 4865 Amaryl 2 Tablets Glimepiride 2mg POM Tablet Uncoated 175/015 Sanofi Aventis Pharma Limited 4866 Amaryl 1 Tablets Glimepiride 1mg POM Tablet Uncoated 175/016 Sanofi Aventis Pharma Limited Metronidazole 500mg, POM Solution for 175/017 Sanofi Aventis Pharma Limited Flagyl Injection 4867 per 100ml Injection Enoxaparin 20mg, per POM Solution for 175/018 Sanofi Aventis Pharma Limited Clexane 20 Injection 4868 0.2ml Injection Enoxaparin 60mg, per POM Solution for 175/019 Sanofi Aventis Pharma Limited Clexane 60 Injection 4869 0.6ml Injection Enoxaparin 40mg, per POM Solution for 175/020 Sanofi Aventis Pharma Limited Clexane 40 Injection 4870 0.4ml Injection Enoxaparin 80mg, per POM Solution for 175/021 Sanofi Aventis Pharma Limited Clexane 80 Injection 4871 0.8ml Injection Glimepiride 1mg + POM Tablet Uncoated 175/022 Sanofi Aventis Pharma Limited Amaryl-M 1mg/250mg Tablets Metformin Hydrochloride 4872 250mg Glimepiride 2mg + POM Tablet Uncoated 175/023 Sanofi Aventis Pharma Limited Amaryl-M 2mg/500mg Tablets Metformin Hydrochloride 4873 500mg 4874 Xatral 10mg Tablets Alfuzosin 10mg POM Tablet Uncoated 175/024 Sanofi Aventis Pharma Limited 4875 Xatral 2.5mg Tablets Alfuzosin 2.5mg POM Tablet Uncoated 175/025 Sanofi Aventis Pharma Limited 4876 Daonil Tablets Glibenclamide 5mg POM Tablet Uncoated 175/026 Sanofi Aventis Pharma Limited Artesunate 25mg/Amodiaquine Artesunate 25mg + POM Tablet Uncoated 175/027 Sanofi Aventis Pharma Limited 4877 67.5mg Tablets Amodiaquine 67.5mg

Page 251 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Coarsucam 25mg/67.5mg Artesunate 25mg + POM Tablet Uncoated 175/028 Sanofi Aventis Pharma Limited 4878 Tablets Amodiaquine 67.5mg Artesunate POM Tablet Uncoated 175/029 Sanofi Aventis Pharma Limited Artesunate 50mg + 50mg/Amodiaquine135mg Amodiaquine 135mg 4879 Tablets Coarsucam 50mg/135mg Artesunate 50mg + POM Tablet Uncoated 175/030 Sanofi Aventis Pharma Limited 4880 Tablets Amodiaquine 135mg Coarsucam 100mg/270 Mg Artesunate 100mg + POM Tablet Uncoated 175/031 Sanofi Aventis Pharma Limited 4881 Tablets Amodiaquine 270mg Artesunate 100/270 Artesunate 100mg + POM Tablet Uncoated 175/032 Sanofi Aventis Pharma Limited 4882 Amodiaquine Tablets Amodiaquine 270mg 4883 Tritace 10mg Capsules Ramipril 10mg POM Tablet Uncoated 175/033 Sanofi Aventis Pharma Limited POM Tablet Modified 175/034 Sanofi Aventis Pharma Limited Epilim CR 500 Tablets Sodium Valproate 500mg 4884 Release POM Tablet Modified 175/035 Sanofi Aventis Pharma Limited Epilim CR 300 Tablets Sodium Valproate 300mg 4885 Release In Activated Polio Virus POM Suspension for 175/036 Sanofi Aventis Pharma Limited Type 1 ( Mahoney) 40 Injection Imovax Polio Vaccine Units + Type 2(Mef-1) 8 Units + Type 3 (Saukett) 4886 32 Units Vibrio Cholerae Straines POM Powder for 175/037 Sanofi Aventis Pharma Limited Shancol Vaccine 4887 (Oral Cholera Vaccine) Injection 4888 Fluconazole 150 Tablets Fluconazole 150mg POM Tablets 175/038 Sanofi Aventis Pharma Limited Docetaxel BP 20mg, per POM Powder for 175/039 Sanofi Aventis Pharma Limited Taxotere Injection 4889 ml Injection Taxotere RTU 80mg/4ml POM Solution for 175/040 Sanofi Aventis Pharma Limited Docetaxel 80mg, per 4ml 4890 Injection infusion Allstar Reusable Insulin Delivery P Medical Device 175/041L Sanofi Aventis Pharma Limited Medical Device 4891 Device 4892 Calbio 200 Nasal Spray Calcitonin 200IU POM Spray , Eye Use 313/001 SAVA Medica Limited, India Azithromycin Dihydrate POM Tablet Uncoated 313/002 SAVA Medica Limited, India Azi Bio 500 Tablets 4893 500mg Azithromycin 200mg, per POM Suspension for 313/003 SAVA Medica Limited, India Azi Bio Suspension 4894 5ml Oral Use Xylometazoline POM Spray For Nasal 313/004 SAVA Medica Limited, India Biomist NS 0.1 Nasal Spray 4895 Hydrochloride 0.1% Use Xylometazoline POM Spray For Nasal 313/005 SAVA Medica Limited, India Biomist NS 0.05 Nasal Spray 4896 Hydrochloride 0.05% Use

Page 252 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Fluticasone Propionate POM Spray For Nasal 313/006 SAVA Medica Limited, India Flutiair 0.05 Nasal Spray 4897 0.05% Use Flutiair -S 250 Powder for Salmeterol 50mcg + POM Powder for 313/007 SAVA Medica Limited, India 4898 Inhalation Fluticasone250mcg Inhalation 4899 Rozatin - 10 Tablets Rosuvastatin 10mg POM Tablet Uncoated 313/008 SAVA Medica Limited, India 4900 Rozatin -20 Tablets Rosuvastatin 20mg POM Tablet Uncoated 313/009 SAVA Medica Limited, India 4901 Esaktive 40 Tablets Esomeprazole 40mg POM Tablet Uncoated 313/010 SAVA Medica Limited, India Mometasone Furoate POM Spray For Nasal 313/011 SAVA Medica Limited, India Momenap Ns 0.05 Nasal Spray 4902 0.05% Use 4903 Nystanova Pessaries Nystatin 100,000 I.U. POM Tablet Vaginal 035/003 Scanpharm A/S, Denmark Multivitamin Mineral GS Solution for Oral 035/013 Scanpharm A/S, Denmark Viminova Drops 4904 Drops Use POM Solution for 035/021 Scanpharm A/S, Denmark Spasmonova Injection Hyoscine Butyl Bromide 4905 Injection POM Solution for 035/028 Scanpharm A/S, Denmark Ergonova Injection Ergometrine Injection 4906 Injection POM Solution for 035/029 Scanpharm A/S, Denmark Oxy Ergonova Injection Ergotocin Maleate 4907 Injection POM Suspension for 035/033 Scanpharm A/S, Denmark Mezonova Suspension Trichozol Syrup 4908 Oral Use 4909 Neo-Polynova Ear/Eye Drops Combination POM Ear/Eye Drops 035/034 Scanpharm A/S, Denmark 4910 Gyno-Nova Pesseries Clotrimazole 100mg POM Tablet Vaginal 035/043 Scanpharm A/S, Denmark Vitamins + Minerals + POM Tablet Uncoated 035/042 Scanpharm A/S, Denmark Pregnatal Tablets 4911 Amino Acids Dexamethasone Sodium POM Solution for 035/044 Scanpharm A/S, Denmark Dexanova Injection 4912 Phosphate 5mg, per ml Injection POM Solution for 035/045 Scanpharm A/S, Denmark Oxytocin Injection Oxytocin 10mg 4913 Injection 4914 Cloronova Ear Drops Chlororamphenical 1% POM Ear Drops 035/047 Scanpharm A/S, Denmark 4915 Cloronova Eye Drops Chlororamphenical 1% POM Eye Drops 035/048 Scanpharm A/S, Denmark 4916 Viminova Tablets Multivitamins GS Tablet Uncoated 035/049 Scanpharm A/S, Denmark 4917 Viminova Syrup Multivitamins P Syrup 035/051 Scanpharm A/S, Denmark 4918 Vitalinova Tonic Multivitamins P Syrup 035/052 Scanpharm A/S, Denmark 4919 Claritine Tablets Loratidine 10mg POM Tablet Uncoated 042/002 Schering-Plough Labo N.V, Belgium 4920 Elocom Cream Mometasone 0.1% POM Cream Topical 042/003 Schering-Plough Labo N.V, Belgium POM Lotion for Topical 042/004 Schering-Plough Labo N.V, Belgium Elocom Lotion Mometasone 0.1% 4921 Use 4922 Elocom Ointment Mometasone 0.1% POM Ointment topical 042/005 Schering-Plough Labo N.V, Belgium

Page 253 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Peg-Inteferon Alfa-2b POM Suspension for 042/006 Schering-Plough Labo N.V, Belgium Peg-Intron 50mcg Injection 4923 50mcg Injection Peg-Inteferon Alfa-2b POM Suspension for 042/007 Schering-Plough Labo N.V, Belgium Peg-Intron 80mcg Injection 4924 80mcg Injection Peg-Inteferon Alfa-2b POM Suspension for 042/008 Schering-Plough Labo N.V, Belgium Peg-Intron 100mcg Injection 4925 100mcg Injection Peg-Inteferon Alfa-2b POM Suspension for 042/009 Schering-Plough Labo N.V, Belgium Peg-Intron 120mcg Injection 4926 120mcg Injection Peg-Inteferon Alfa-2b POM Suspension for 042/010 Schering-Plough Labo N.V, Belgium Peg-Intron 150mcg Injection 4927 150mcg Injection POM Powder for 042/011 Schering-Plough Labo N.V, Belgium Ramicade Injection Infliximab 100mg 4928 Injection Interferon Alfa 2b POM Solution for 042/012 Schering-Plough Labo N.V, Belgium Intron A Solution 18 IU 4929 18M.I.U Injection Interferon Alfa 2b POM Solution for 042/013 Schering-Plough Labo N.V, Belgium Intron A Solution 25 IU 4930 25M.I.U Injection POM Suspension for 042/015 Schering-Plough Labo N.V, Belgium Caelyx Injection Doxorubicin 2mg, per ml 4931 Injection POM Spray For Nasal 042/016 Schering-Plough Labo N.V, Belgium Nasonex Aqueous Nasal Spray Mometasone 4932 Use 4933 Temodal 5mg Capsules Temozolomide 5mg POM Capsule oral 042/017 Schering-Plough Labo N.V, Belgium 4934 Temodal 20mg Capsules Temozolomide 20mg POM Capsule oral 042/018 Schering-Plough Labo N.V, Belgium 4935 Temodal100mg Capsules Temozolomide 100mg POM Capsule oral 042/019 Schering-Plough Labo N.V, Belgium 4936 Temodal 250 Mg Capsules Temozolomide 250mg POM Capsule oral 042/020 Schering-Plough Labo N.V, Belgium Des-Loratadine 0.5mg, POM Syrup 042/021 Schering-Plough Labo N.V, Belgium Aerius Syrup 4937 per ml 4938 Aerius Tablets Des-Loratadine 5mg POM Tablet Uncoated 042/022 Schering-Plough Labo N.V, Belgium Betamethasone POM Injection 042/023 Schering-Plough Labo N.V, Belgium Dipropionate Diprofos Injection 5mg+Betamethasone 4939 Sodium Sulphate 2.5mg Betamethasone 0.25mg POM Tablet Uncoated 042/024 Schering-Plough Labo N.V, Belgium Celestamine Tablets + Dexchlorpheniramine 4940 2mg Rocuronium 10mg, per POM Solution for 042/025 Schering-Plough Labo N.V, Belgium Esmeron Injection 4941 ml Injection

Page 254 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Ocetinidine P Solution for Oral 321/001L Schulke & Mayr GBMH, Germany Dihydrochloride 0.1%w/v Use Octenisept Solution + Phenoxy Ethanol 4942 2.0%w/v Lidocaine Hydrochloride POM Solution for 319/001 Septodont, France Lignospan Special Injection 2% + 1:80,000 Injection 4943 Adrenaline Tartrate SII Polyvalent Anti -Snake Polyvalent Anti Snake POM Solution for 035/002 Serum Institute of India 4944 Venom Injection Serum Injection Bromocriptine Mesylate POM Tablet Uncoated 053/001 Serum Institute of India Sicriptin Tablets 4945 2.5mg Hepatitis B Vaccine (rDNA) POM Suspension for 053/003 Serum Institute of India Hepatitis B Vaccine 4946 Injection Injection S11 Rabivax- Liquid (Rabies Rabies Vaccine, Human POM Suspension for 053/004 Serum Institute of India 4947 Vaccine USP) I.P. (Liquid) Injection Measles Vaccine, Live, 1000 CCID50 Of Live POM Suspension for 053/005 Serum Institute of India Attenuated (Freeze Dried) Measles Virus Particles, Injection 4948 Injection per 0.5ml Rubella Vaccine 1000 POM Suspension for 053/006 Serum Institute of India Rubella Vaccine/Mumps Ccid50 + Mumps 5000 Injection Vaccine/Measles Vaccine, Ccid50 + Measles 1000 Live,Atten.(Freeze Dried 4949 Ccid50, Per 0.5ml Vincristine Sulphate BP POM Powder for 053/007 Serum Institute of India Vincristine 1mg, per Vial 4950 (Lyophilised) Injection Injection POM Powder for 053/008 Serum Institute of India Cisplatin BP Injection Cisplatin 1mg, per ml 4951 Injection POM Suspension for 053/009 Serum Institute of India Tetanus Antitoxin BP Injection Tetanus Antitoxin 4952 Injection Tetanus Toxoid Vaccine POM Suspension for 053/010 Serum Institute of India Tetanus Toxoid 1500IU 4953 adsorbed Injection Injection POM Suspension for 053/011 Serum Institute of India Diptheria-Tetanus-Pertusis Diptheria 30IU + Tetanus Injection Vaccine adsorbed Injection 40IU + Pertusis 4IU 4954 POM Lyophilised Powder 053/012 Serum Institute of India Measles and Rubella Vacine Measles And Rubella for Injection Live Vaccine Live 4955 Seven Seas Orange Syrup + GS Syrup 154/001 Seven Seas Ltd, England Cod Liver Oil + Vitamins 4956 Cod Liver Oil

Page 255 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Seven Seas One A Day Pure GS Capsule oral 154/003 Seven Seas Ltd, England Cod Liver Oil + Vitamin Cod Liver Oil + Vitamins 4957 Capsules Seven Seas Cherry Flavoured GS Syrup 154/004 Seven Seas Ltd, England Cod Liver Oil + Vitamins 4958 Cod Liver Liquid Seven Seas One A Day Cod GS Capsule oral 154/007 Seven Seas Ltd, England Cod Liver Oil + Evening Liver Oil + Evening Primrose Primerose 4959 Capsules Seven Seas One A Day GS Capsule oral 154/008 Seven Seas Ltd, England Odourless Garlic Pearls Garlic Oil 6mg 4960 Capsules Seven Seas One A Day Cod Cod Liver Oil + GS Capsule oral 154/011 Seven Seas Ltd, England 4961 Liver Oil + Glusamine Capsules Glusamine 1500mg Seven Seas Multivitamins + P Capsule oral 154/013 Seven Seas Ltd, England Minerals + Multivitamins 4962 Minerals Capsules 4963 Minadex Tonic Vitamins + Minerals GS Syrup 154/019 Seven Seas Ltd, England 4964 Diproson Cream Betamethasone 0.05% POM Cream Topical 057/034 Shalina Healthcare Limited, UAE Cetirizine 5mg + P Syrup 075/001 Shalina Healthcare Limited, UAE Bromhexine 4mg + Alcozyme Xp Syrup Ammonium Chloride 4965 125mg Salbutamol 2mg + POM Syrup 075/002 Shalina Healthcare Limited, UAE Bromhexine 4mg + Shaltoux Syrup Guaiphenesin 100mg + 4966 Menthol 1mg 4967 Ketazol Shampoo Ketoconazole 2%w/w POM Shampoo 075/003 Shalina Healthcare Limited, UAE Dimethicone 50mg + P Suspension for 075/004 Shalina Healthcare Limited, UAE Magnesium Hydroxide Oral Use Polygel Suspension 250mg + Dried Aluminium Hydroxide 4968 250mg Dimethicone 50mg + P Syrup 075/005 Shalina Healthcare Limited, UAE Magnesium Hydroxide Polygel Mango Suspension 250mg + Dried Aluminium Hydroxide 4969 250mg

Page 256 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Dimethicone 50mg + P Suspension for 075/006 Shalina Healthcare Limited, UAE Magnesium Hydroxide Oral Use Polygel Mint Suspension 250mg + Dried Aluminium Hydroxide 4970 250mg 4971 Floxan 250mg Tablets Ofloxacin 250mg POM Tablet Uncoated 075/007 Shalina Healthcare Limited, UAE 4972 Floxan 500mg Tablets Ofloxacin 500mg POM Tablet Uncoated 075/008 Shalina Healthcare Limited, UAE Sulphamethoxazole POM Suspension for 075/009 Shalina Healthcare Limited, UAE Shaltrim Suspension 40mg + Trimethoprim Oral Use 4973 200mg Methyl Salicylate 7%w/w GS Ointment topical 075/010 Shalina Healthcare Limited, UAE Leopard Baume 4974 + Menthol 7%w/w 4975 Gogynax Cream Clotrimazole 2% POM Cream Topical 075/011 Shalina Healthcare Limited, UAE Aspirin 300mg + GS Capsule oral 075/012 Shalina Healthcare Limited, UAE Zanzicap Capsules Paracetamol 300mg + 4976 Caffeine 30mg Allantoin 1.0% + P Cream Topical 075/013 Shalina Healthcare Limited, UAE Monalisa Cream Hydroquinone 2% + 4977 Vitamin E 0.3%w/w Silver Sulphadiazine P Cream Topical 075/014 Shalina Healthcare Limited, UAE Flazine Cream 4978 1.0% Metronidazole 125mg, POM Suspension for 075/015 Shalina Healthcare Limited, UAE Metazol Suspension 4979 per 5ml Oral Use 4980 Rufenac-50 Tablets Diclofenac 50mg P Tablet Film coated 075/016 Shalina Healthcare Limited, UAE 4981 Shalvit Syrup Multivitamin GS Syrup 075/017 Shalina Healthcare Limited, UAE Paracetamol 500mg + P Tablet Uncoated 075/018 Shalina Healthcare Limited, UAE Rufedol Tablets 4982 Diclofenac 50mg Chloroxylenol 4.8% GS Solution for Topical 075/019 Shalina Healthcare Limited, UAE Germol Solution Terpineol + 9% Ethanol Use 4983 13.1% 4984 Rufenac Gel Diclofenac 1.16% P Gel Topical 075/020 Shalina Healthcare Limited, UAE 4985 Magnavit Capsules Minerals + Multivitamins P Capsule oral 075/021 Shalina Healthcare Limited, UAE 4986 Amlox-5 Tablets Amlodipine 5mg POM Tablet Uncoated 075/022 Shalina Healthcare Limited, UAE 4987 Amlox-10 Tablets Amlodipine 10mg POM Tablet Uncoated 075/023 Shalina Healthcare Limited, UAE 4988 Ketazol Cream Ketoconazole 2%w/w POM Cream Topical 075/024 Shalina Healthcare Limited, UAE

Page 257 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER POM Cream Topical 075/025 Shalina Healthcare Limited, UAE Betamethasone 0.643mg + Gentamycin 1mg + Epiderm Cream Tolnaftate 10mg + Iodochlorohydroxyquinolo ne 10mg 4989 P Syrup 075/026 Shalina Healthcare Limited, UAE Ferric Ammonium 250mg + Folic Acid 0.5mg + Marfol Syrup Cyanocobalamin 5mcg, per 5ml 4990 P Capsule oral 075/027 Shalina Healthcare Limited, UAE Efishal 200 Capsules Alpha Tocopherol 200mg 4991 POM Lotion for Topical 075/028 Shalina Healthcare Limited, UAE Betamethasone 0.643mg Use + Gentamycin 1mg + Epiderm Lotion Tolnaftate 10mg + Iodochlorohydroxyquinolo ne 10mg 4992 4993 Betasol Cream Clobetasol 0.05%w/w POM Cream Topical 075/029 Shalina Healthcare Limited, UAE Glibenclamide 5mg + POM Tablet Uncoated 075/030 Shalina Healthcare Limited, UAE Gliben M Tablets 4994 Metformin 500mg Ibuprofen 200mg + P Tablet Uncoated 075/032 Shalina Healthcare Limited, UAE Ibucap Tablets Paracetamol 325mg + 4995 Caffeine 30mg POM Solution for Topical 075/033 Shalina Healthcare Limited, UAE Betasol Solution Clobetasol 0.05%w/v 4996 Use Polymyxin B 5000 IU + POM Ointment topical 075/035 Shalina Healthcare Limited, UAE Neocin Ointment Bacitracin Zinc 400 IU + 4997 Neomycin 3400 IU/g Haemoglobin 2.095gm + P Syrup 075/036 Shalina Healthcare Limited, UAE Ferric Ammonium Nitrate Hemoforce Syrup 125mg + Cynanocobalamin 7.5mg 4998 + Folic Acid 0.51gm Triclosan 1.0% + GS Solid Soap 075/037 Shalina Healthcare Limited, UAE Germol Soap Triclocarban 0.40% + 4999 Glycerine 0.5%

Page 258 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Trimethoprim 160mg + POM Tablet Uncoated 075/038 Shalina Healthcare Limited, UAE Sulfatrim Forte Tablets Sulphamethoxazole 5000 800mg Calcium 500mg + Vitamin P Tablet Uncoated 075/040 Shalina Healthcare Limited, UAE Cal - D Tablets 5001 D3 250mg 5002 Kifaru 50 Tablets Sildenafil Citrate 50mg POM Tablet Uncoated 075/041 Shalina Healthcare Limited, UAE Aluminium Hydroxide P Tablet Uncoated 075/042 Shalina Healthcare Limited, UAE 300mg + Magnesium Polygel Tablets Hydroxide 25mg + 5003 Simethicone 25mg 5004 Loprade Tablets Loperamide 2mg P Tablet Uncoated 075/043 Shalina Healthcare Limited, UAE POM Nasal drops 075/044 Shalina Healthcare Limited, UAE Clarinez Nasal Drops (Paed) Xylometazoline 0.05%w/v 5005 5006 Clarinez Nasal Drops (Adult) Xylometazoline 0.1%w/v POM Nasal drops 075/045 Shalina Healthcare Limited, UAE 5007 Tanzol Tablets Albendazole 400mg POM Tablet Uncoated 075/046 Shalina Healthcare Limited, UAE POM Tablet Uncoated 075/047 Shalina Healthcare Limited, UAE Sulfamethoxazole 400mg Sulfatrim Tablets + Trimethoprim 80mg 5008 5009 Wormex -100 Tablets Mebendazole 100mg POM Tablet Uncoated 075/048 Shalina Healthcare Limited, UAE 5010 Super Apeti Tablets Cyproheptadine 4mg POM Tablet Uncoated 075/049 Shalina Healthcare Limited, UAE 5011 Shalcip Tablets Ciprofloxacin 500mg POM Tablet Uncoated 075/050 Shalina Healthcare Limited, UAE 5012 Tinizol 500 Tablets Tinidazole 500mg POM Tablet Uncoated 075/051 Shalina Healthcare Limited, UAE Paracetamol 120mg, per GS Solution for Oral 075/052 Shalina Healthcare Limited, UAE Amidol Syrup 5013 5mls Use Diphenhydramine P Syrup 075/053 Shalina Healthcare Limited, UAE Hydrochlorothiazide BP Shaltoux XPS Syrup 14.00mg + Ammonium 5014 Chloride BP 135.0mg 5015 Amidol Tablets Paracetamol 500mg POM Tablet Uncoated 075/054 Shalina Healthcare Limited, UAE Menthol 2.82% + GS Ointment topical 075/055 Shalina Healthcare Limited, UAE Camphor 5.25% + Leopard Vapour Rub Thymol 0.1% + Turpentine 5.57% + 5016 Eucalypt 1.49% + 0.54% POM Solution for 075/056 Shalina Healthcare Limited, UAE Shalcip Injection Ciprofloxacin 0.2% 5017 infusion Ascorbic Acid 200mg + P Tablet Chewable 075/057 Shalina Healthcare Limited, UAE Cevite Tablets Sodium Ascorbate 5018 300mg

Page 259 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Omeprazole 20mg + POM Capsule sublingual 075/058 Shalina Healthcare Limited, UAE Omeshal -D Capsules 5019 Domperidone 10mg 5020 Omeshal Capsules Omeprazole 20mg POM Capsule oral 075/059 Shalina Healthcare Limited, UAE Chlorpheniramine 2mg + GS Tablet Uncoated 075/060 Shalina Healthcare Limited, UAE Paracetamol 500mg + Amido Cold & Flu Tablets Phenylephrine 5mg + 5021 Caffeine 30mg Chlorpheniramine1mg + GS Syrup 075/061 Shalina Healthcare Limited, UAE Amidol Cold And Flu Syrup Paracetamol 125mg + 5022 Phenylephrine 2.5mg GS Tablet Effervescent 075/062 Shalina Healthcare Limited, UAE Cevite Effervescent Tablets Ascorbic Acid 1000mg 5023 Ferric Ammonium Citrate P Suspension for 075/063 Shalina Healthcare Limited, UAE 160mg + Folic Acid Injection Hemoforce Plus Syrup 0.5mg + Cynocobalamin 5024 7.5mg Mentha Piperata 42.5% + GS Nasal Inhaler 075/064 Shalina Healthcare Limited, UAE Leopard Nasal Inhaler 5025 Cinnamon 40.0% Cyproheptadine P Syrup 075/065 Shalina Healthcare Limited, UAE Super Apeti Plus Syrup Hydrochloride 2mg + 5026 Multivitamins P Suspension for 075/066 Shalina Healthcare Limited, UAE Wormex Suspension Mebendazole 100mg 5027 Oral Use Ibuprofen 400mg + P Capsule oral 075/067 Shalina Healthcare Limited, UAE Ibucap Forte Capsules Paracetamol 325mg + 5028 Cafeine 30mg Amoxycillin Trihydrate POM Powder for 075/068 Shalina Healthcare Limited, UAE Zanitin Duo 1.2g Powder For 1000mg + Clavulanate Injection Injection 5029 Potassium 200mg Ciprofloxacin 500mg + POM Tablet Uncoated 075/069 Shalina Healthcare Limited, UAE Shalcip TZ Tablets 5030 Tindazole 600mg POM Solution for 075/070 Shalina Healthcare Limited, UAE Metazol Infusion 100mls Metronidazole 0.5w/v 5031 infusion Ascorbic Acid 50mg, per P Syrup 075/071 Shalina Healthcare Limited, UAE Cevite Syrup 5032 5ml Diclofenac Potassium P Tablet Uncoated 075/072 Shalina Healthcare Limited, UAE 50mg + Paracetamol Rufezone Plus Tablets 500mg + Chlorzoxazone 5033 250mg

Page 260 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Chloroxylenol 0.3%w/v + GS Cream Topical 075/073 Shalina Healthcare Limited, UAE Triclosan 0.3%w/v + Germol Cream Edetic acid (as 5034 Potassium) 0.2%w/v Sulphadoxine 500mg + POM Tablet Uncoated 075/074 Shalina Healthcare Limited, UAE Maladox Tablets 5035 Pyrimethamine 25mg Gogynax Clotrimazole Vaginal POM Tablet Uncoated 075/075 Shalina Healthcare Limited, UAE Clotrimazole 100mg 5036 Inserts Glycyrrhiza glabra 20mg GS Lozenges 075/076 Shalina Healthcare Limited, UAE Shaltoux Natural Cough + Terminalia belerica Lozenges 5mg + Zingibar Officinalis 5037 5mg Albendazole 400mg, per P Suspension for 075/077 Shalina Healthcare Limited, UAE Tanzol Suspension 5038 10ml Oral Use Artemether 180mg + POM Powder for Oral 075/078 Shalina Healthcare Limited, UAE Shal' Artem Dry Syrup 5039 Lumefantrine 1080mg Suspension POM Powder for Topical 075/079 Shalina Healthcare Limited, UAE Canderm Powder Clotrimazole USP 1%w/w 5040 use Amoxycillin 875mg + POM Tablet Film coated 075/080 Shalina Healthcare Limited, UAE ZANITIN DUO 1000 Tablets Clavulanate Potassium 5041 125mg Amoxycillin 500mg + POM Tablet Film coated 075/081 Shalina Healthcare Limited, UAE ZANITIN DUO 562.5 Tablets Clavulanate Potassium 5042 62.5mg Amoxycillin 400mg + POM Powder for Oral 075/082 Shalina Healthcare Limited, UAE ZANITIN DUO 457 Oral Clavulanate Potassium Suspension Suspension 5043 57mg POM Powder for 075/083 Shalina Healthcare Limited, UAE Ceftriaxone Injection Ceftriaxone 1g 5044 Injection 5045 Magnavit Tonic Syrup Multivitamins & Minerals P Syrup 075/084 Shalina Healthcare Limited, UAE Azithromycin Dihydrate POM Tablet Uncoated 075/085 Shalina Healthcare Limited, UAE Shalzin Tablets 5046 USP 500mg Azithromycin Dihydrate POM Suspension for 075/086 Shalina Healthcare Limited, UAE Shalzin Suspension 5047 USP 100mg, per 5ml Oral Use 5048 Kifaru 100 Tablets Sildenafil Citrate 100mg POM Tablet Film coated 075/087 Shalina Healthcare Limited, UAE 5049 Gentamycin Ear/Eye Drops Gentamycin 0.3%w/v POM Ear/Eye Drops 075/088 Shalina Healthcare Limited, UAE

Page 261 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Sodium Chloride + GS Powder for Oral 075/089 Shalina Healthcare Limited, UAE Potassium Chloride + Suspension Seloral Oral Rehydration Salt Sodium Citrate + 5050 Dextrose Citric Acid 2.18g + P Granules for Oral 075/090 Shalina Healthcare Limited, UAE Polyfast Granules Sodium Bicarbonate Use 5051 2.32g Vitamin B3 I.H 9.31mg + GS Cream Topical 075/091L Shalina Healthcare Limited, UAE Epiderm Light Cream Vitamin C I.H 23.28mg + 5052 Vitamin E I.H 2.33mg Vitamin B3 I.H 9.25mg + GS Lotion for Topical 075/092L Shalina Healthcare Limited, UAE Epiderm Light Lotion Vitamin C I.H 23.14mg + Use 5053 Vitamin E I.H 2.31mg Artemether 80mg + POM Tablet Uncoated 075/093 Shalina Healthcare Limited, UAE Shal Artem Tablets 5054 Lumefantrine 480mg Artemether 20mg + POM Tablet Uncoated 075/094 Shalina Healthcare Limited, UAE Shal Artem Tablets 5055 Lumefantrine 120mg Amoxicillin Trihydrate POM Tablet Uncoated 075/095 Shalina Healthcare Limited, UAE Amoxy 500 Capsules 5056 500mg Amoxicillin Trihydrate POM Tablet Uncoated 075/096 Shalina Healthcare Limited, UAE Amoxy 250 Capsules 5057 250mg POM Powder for 075/097 Shalina Healthcare Limited, UAE Ampicillin 1000 Injection Ampicillin Sodium BP 1g 5058 Injection Ampicillin Sodium BP POM Powder for 075/098 Shalina Healthcare Limited, UAE Ampicillin 500 Injection 5059 500mg Injection Fortified Benzylpenicillin Procaine Benzyl Penicillin POM Powder for 075/099 Shalina Healthcare Limited, UAE 5060 Injection BP 4M.I.U Injection Benzathine Benzylpenicllin 2.4 Benzathine Benzyl POM Powder for 075/100 Shalina Healthcare Limited, UAE 5061 Injection Penicillin 2,400,000 IU Injection Benzyl Penicillin POM Powder for 075/101 Shalina Healthcare Limited, UAE Benzylpenillin 5 Injection 5062 5,000,000 IU Injection Phenoxymethyl Penicillin 250 Phenoxymethyl Penicillin POM Tablet Uncoated 075/102 Shalina Healthcare Limited, UAE 5063 Tablets Potassium 250mg POM Solution for 075/103 Shalina Healthcare Limited, UAE Gentamycin 40 Injection Gentamycin 40mg, per ml 5064 Injection

Page 262 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER P Syrup 075/104 Shalina Healthcare Limited, UAE Sodium Feredetate 11mg + Folic Acid 0.5mg + Hemoforce Plus Syrup Cyanocobalamin 5mcg + Zinc Sulphate 3.33mg + 20mg 5065 Lamivude/Zidovudine tablets Lamuvidine 150mg + POM Tablet Film coated 442/001 Shangai Denaso Biopharmaceuticals Ltd Zidovudine 300mg Tablet 5066 5067 Efavirenz 600 Tablets Efavirenz 600mg POM Tablet Film coated 442/002 Shangai Denaso Biopharmaceuticals Ltd P Capsule oral 323/001L Shanghai Eternal Biotechnology Co. Aloe Soft Gel Capsules Aloe Vera 500mg 5068 Limited, China Broken Ganoderma Lucidium Ganoderma Lucidium P Capsule oral 323/002L Shanghai Eternal Biotechnology Co. 5069 Spore Softgel Capsules 500mg Limited, China P Capsule oral 323/003L Shanghai Eternal Biotechnology Co. Fish Oils Softgel Capsules Fish Oil 1000mg 5070 Limited, China P Capsule oral 323/004L Shanghai Eternal Biotechnology Co. Lecithin Soft Capsules Soyabean Lecithin 22.3% 5071 Limited, China Natural Vitamin E Soft Gel P Capsule oral 323/005L Shanghai Eternal Biotechnology Co. Vitamin E 500mg 5072 Capsules Limited, China P Capsule oral 323/006L Shanghai Eternal Biotechnology Co. Propolis Softgel Capsules Propolis Extracts 55% 5073 Limited, China Soy Bean Extracts P Capsule oral 323/007L Shanghai Eternal Biotechnology Co. Soy Isoflavones Capsules 5074 67.06% Limited, China P Capsule oral 323/008L Shanghai Eternal Biotechnology Co. Spirulina Soft Gel Capsules Spirulina 150mg 5075 Limited, China POM Powder for 269/001 Shanghai Pharmateq Company Ltd, China Kanamycin Injection Kanamycin 1000mg 5076 Injection Calcium Gluconate POM Solution for 269/002 Shanghai Pharmateq Company Ltd, China Calcium Gluconate Injection 5077 10%w/v Injection Promethazine 50mg, per POM Solution for 269/003 Shanghai Pharmateq Company Ltd, China Promethazine Injection 5078 2ml Injection POM Solution for 269/004 Shanghai Pharmateq Company Ltd, China Diclofenac Sodium Injection Diclofenac 75mg, per 3ml 5079 Injection POM Solution for 269/005 Shanghai Pharmateq Company Ltd, China Atropine Injection Atropine 0.6mg, per ml 5080 Injection Furosemide 20mg, per POM Solution for 269/006 Shanghai Pharmateq Company Ltd, China Furosemide Injection 5081 2ml Injection

Page 263 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Dexamethasone Sodium Dexamethasone 4mg, POM Solution for 269/007 Shanghai Pharmateq Company Ltd, China 5082 Injection per ml Injection POM Solution for 269/008 Shanghai Pharmateq Company Ltd, China Adrenaline Injection Adrenaline 1mg, per ml 5083 Injection POM Solution for 269/010 Shanghai Pharmateq Company Ltd, China Oxytocin Injection Oxytocin 10IU/Ml 5084 Injection Phytomenadione 10mg, POM Solution for 269/011 Shanghai Pharmateq Company Ltd, China Menadione Injection 5085 per ml Injection Quinine Dihydrochloride POM Solution for 269/012 Shanghai Pharmateq Company Ltd, China Quinine 600mg, per 2ml 5086 Injection Injection POM Powder for 269/013 Shanghai Pharmateq Company Ltd, China Hydrocortisone Injection Hydrocortisone 100mg 5087 Injection POM Tablet Uncoated 066/001 Shaphaco Pharmaceutical Industries , Zwagra Tablets Sildenafil 50mg 5088 Yemen POM Tablet Uncoated 066/002 Shaphaco Pharmaceutical Industries , Saheal Tablets Tadalafil 20mg 5089 Yemen 5090 Koflyn Syrup Herbal Extracts P Syrup 134/001 Shelys Pharmaceuticals Limited, Tanzania 5091 Diclofenac Sodium Tablets Diclofenac 50mg P Tablet Uncoated 134/003 Shelys Pharmaceuticals Limited, Tanzania Chloramphenicol 125mg, POM Suspension for 134/004 Shelys Pharmaceuticals Limited, Tanzania Chloramphenicol Suspension 5092 per 5ml Oral Use GS Solution for Oral 134/005 Shelys Pharmaceuticals Limited, Tanzania Shelys Gripe Water Bicarbonate 5093 Use 5094 Ibuprofen 200 Tablets Ibuprofen 200mg P Tablet Uncoated 134/006 Shelys Pharmaceuticals Limited, Tanzania Amoxicillin 125mg, per POM Granules for Oral 134/007 Shelys Pharmaceuticals Limited, Tanzania Amolin Suspension 5095 5ml Suspension Paracetamol 120mg, per GS Suspension for 134/008 Shelys Pharmaceuticals Limited, Tanzania Sheladol Suspension 5096 5ml Oral Use 5097 Ampishel Capsules Ampicillin 250mg POM Capsule oral 134/009 Shelys Pharmaceuticals Limited, Tanzania 5098 Hemovit Capsules Haematic Preparation P Capsule oral 134/010 Shelys Pharmaceuticals Limited, Tanzania 5099 Hemovit Syrup Haematic Preparation P Syrup 134/011 Shelys Pharmaceuticals Limited, Tanzania Acetyl Salicylic Acid P Tablet Uncoated 134/012 Shelys Pharmaceuticals Limited, Tanzania Aspirin Tablets 5100 300mg 5101 Histin Tablets Chlorpheniramine 4mg P Tablet Uncoated 134/013 Shelys Pharmaceuticals Limited, Tanzania Sulphamethoxazole POM Tablet Uncoated 134/015 Shelys Pharmaceuticals Limited, Tanzania Shetrim Tablets 400mg + Trimethoprim 5102 80mg 5103 Mebendazole Tablets Mebendazole 200mg P Tablet Uncoated 134/016 Shelys Pharmaceuticals Limited, Tanzania Albendazole 200mg, per POM Suspension 134/017 Shelys Pharmaceuticals Limited, Tanzania Alben Suspension 5104 10ml

Page 264 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 5105 Shelgyl 200 Tablets Metronidazole 200mg POM Tablet Uncoated 134/018 Shelys Pharmaceuticals Limited, Tanzania 5106 Chloramphenicol Capsules Chloramphenicol 250mg POM Capsule oral 134/020 Shelys Pharmaceuticals Limited, Tanzania 5107 Ascorbic Acid Tablets Ascorbic Acid 100mg GS Tablet Uncoated 134/021 Shelys Pharmaceuticals Limited, Tanzania GS Solution for Topical 134/022 Shelys Pharmaceuticals Limited, Tanzania Bactol Solution Chloroxylenol 4.8%w/w 5108 Use 5109 Folic Acid Tablets Folic Acid 5mg P Tablet Uncoated 134/023 Shelys Pharmaceuticals Limited, Tanzania Pyrimethamine 500mg + P Tablet Uncoated 134/024 Shelys Pharmaceuticals Limited, Tanzania Sulphadar Tablets 5110 Sulphadoxine 25mg 5111 Erythromycin Tablets Erythromycin 250mg POM Tablet Uncoated 134/025 Shelys Pharmaceuticals Limited, Tanzania Salbutamol 2mg + POM Syrup 134/026 Shelys Pharmaceuticals Limited, Tanzania Mucolyn Asthalin Syrup Bromhexine 4mg, per 5112 5ml 5113 Asthalin Syrup Salbutamol 2mg, per 5ml POM Syrup 134/028 Shelys Pharmaceuticals Limited, Tanzania Sulfamethoxazole BP POM Syrup 134/029 Shelys Pharmaceuticals Limited, Tanzania Shetrim Per 5ml 200mg + Trimethoprim 5114 BP 40mg 5115 Cloxashel Capsules Cloxacillin 250mg POM Capsule oral 134/030 Shelys Pharmaceuticals Limited, Tanzania 5116 Vitamin B Complex Tablets Vitamin B Complex P Tablet Uncoated 134/031 Shelys Pharmaceuticals Limited, Tanzania 5117 Amolin Capsules Amoxicillin 250mg POM Capsule oral 134/032 Shelys Pharmaceuticals Limited, Tanzania Cloxacillin 125mg + POM Suspension for 134/034 Shelys Pharmaceuticals Limited, Tanzania Cloxam Dry Syrup Ampicillin 125mg, per Oral Use 5118 5ml 5119 Megavit Syrup Multivitamins GS Syrup 134/035 Shelys Pharmaceuticals Limited, Tanzania Hyoscine Butyl Bromide POM Tablet Uncoated 134/036 Shelys Pharmaceuticals Limited, Tanzania Hyosine Butyl Bromide Tablets 5120 10mg Ammonium Chloride BP P Syrup 134/037 Shelys Pharmaceuticals Limited, Tanzania 50mg + Pseudoephedrine Hydrochloride 10mg + Mucolyn Paediatric Syrup Chlorpheniramine Maleate BP 2mg + Dextromethorphan Hydrobromide BP 5mg, 5121 per 5ml 5122 Feritone Syrup Haematic Preparation P Syrup 134/038 Shelys Pharmaceuticals Limited, Tanzania 5123 Praziquantel 600mg Tablets Praziquantel 600mg POM Tablet Film coated 134/039 Shelys Pharmaceuticals Limited, Tanzania Bromhexine 8mg + POM Capsule oral 134/040 Shelys Pharmaceuticals Limited, Tanzania Bromoxil Capsules 5124 Amoxicillin 250mg

Page 265 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Bromhexine 4mg + POM Syrup 134/041 Shelys Pharmaceuticals Limited, Tanzania Bromoxil Syrup 100ml 5125 Amoxicillin 125mg Pyrimethamine 25mg + P Tablet Uncoated 134/042 Shelys Pharmaceuticals Limited, Tanzania Sulphadar Tablets 5126 Sulphadoxine 500mg 5127 Sheladol Tablets Paracetamol 500mg GS Tablet Uncoated 134/044 Shelys Pharmaceuticals Limited, Tanzania Metronidazole 200mg, POM Suspension for 134/045 Shelys Pharmaceuticals Limited, Tanzania Shelgyl Oral Suspension 5128 per 5ml Oral Use P Syrup 134/046 Shelys Pharmaceuticals Limited, Tanzania Ammonium Chloride Mucolyn Syrup 50mg + Bromhexine 4mg + Chlorpheniramine 2mg. 5129 5130 Ampishel Syrup Ampicillin 125mg POM Syrup 134/048 Shelys Pharmaceuticals Limited, Tanzania POM Powder for Oral 134/049 Shelys Pharmaceuticals Limited, Tanzania Erthromycin Dry Syrup Erythromycin 125mg 5131 Suspension Paracetamol 500mg + P Tablet Uncoated 134/050 Shelys Pharmaceuticals Limited, Tanzania Diclopar 550mg Tablets 5132 Diclofenac 50mg Amodiaquine 50mg, per POM Suspension 134/051 Shelys Pharmaceuticals Limited, Tanzania Amodar Suspension 5133 5ml 5134 Cipron Tablets Ciprofloxacin 500mg POM Tablet oral 134/052 Shelys Pharmaceuticals Limited, Tanzania Chlorpheniramine 1mg + P Syrup 134/053 Shelys Pharmaceuticals Limited, Tanzania Coldril Syrup Paracetamol 120mg + 5135 Pseudoephedrine 10mg Pyrimethamine 25mg + P Tablet Uncoated 134/054 Shelys Pharmaceuticals Limited, Tanzania Malafin Tablets Sulphamethoxypyrazine 5136 500mg 5137 Malather Tablets Artesunate BP 100mg POM Tablet Uncoated 134/055 Shelys Pharmaceuticals Limited, Tanzania Paracetamol BP 500mg + POM Capsule oral 134/056 Shelys Pharmaceuticals Limited, Tanzania Pseudoephedrine Coldril Capsules Hydrochloride BP 30mg + Chlorpheniramine 5138 Maleate BP 2mg 5139 Amodar Tablets Amodiaquine 260mg POM Tablet Uncoated 134/057 Shelys Pharmaceuticals Limited, Tanzania Simethicone 25mg + P Suspension for 134/058 Shelys Pharmaceuticals Limited, Tanzania Aluminium Hydroxide Oral Use Gastocid Suspension 220mg + Magnesium 5140 Hydroxide 195mg Dried Aluminium GS Tablet Chewable 134/059 Shelys Pharmaceuticals Limited, Tanzania Gastrocid Chewable Tablets Hydroxide + Magnesium 5141 Trisilicate 395mg

Page 266 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 5142 Flucozal 150 Tablets Fluconazole 150mg POM Tablet Uncoated 134/060 Shelys Pharmaceuticals Limited, Tanzania 5143 Flucozal 200 Tablets Fluconazole 200mg POM Tablet Uncoated 134/062 Shelys Pharmaceuticals Limited, Tanzania Amodiaquine 200mg + POM Tablet Uncoated 134/063 Shelys Pharmaceuticals Limited, Tanzania Maladar Adult Kit Tablets 5144 Artesunate 50mg Amodiaquine 100mg + POM Tablet Uncoated 134/064 Shelys Pharmaceuticals Limited, Tanzania Maladar Pead Kit Tablets 5145 Artesunate 50mg Sodium Chloride + GS Powder for Oral 134/065 Shelys Pharmaceuticals Limited, Tanzania Sodium Citrate + Solution Save Oral Rehydration Salt Potassium Chloride + 5146 Glucose 5147 Ped Zinc Tablets Zinc Sulphate 20mg GS Tablet Uncoated 134/066 Shelys Pharmaceuticals Limited, Tanzania 5148 Acefen Tablets Aceclofenac 100mg P Tablet Uncoated 134/067 Shelys Pharmaceuticals Limited, Tanzania 5149 Levoz Tablets Levofloxacin 500mg POM Tablet Uncoated 134/068 Shelys Pharmaceuticals Limited, Tanzania 5150 Njoi Tablets Sildenafil 50mg POM Tablet Uncoated 134/069 Shelys Pharmaceuticals Limited, Tanzania 5151 Quinalin Syrup Quinine 100g/5ml POM Syrup 134/070 Shelys Pharmaceuticals Limited, Tanzania Paracetamol 500mg + P Tablet Uncoated 134/071 Shelys Pharmaceuticals Limited, Tanzania Diclopar-Ultra Tablets 5152 Diclofenac 50mg 5153 Azuma - 250 Tablets Azithromycin 250mg POM Tablet Uncoated 134/072 Shelys Pharmaceuticals Limited, Tanzania 5154 Azuma - 500 Tablets Azithromycin 500mg POM Tablet Film coated 134/073 Shelys Pharmaceuticals Limited, Tanzania POM Suspension for 134/074 Shelys Pharmaceuticals Limited, Tanzania Azuma Suspension Azithromycin 200mg 5155 Oral Use 5156 Sheltrizine Tablets Cetrizine 10mg P Tablet Uncoated 134/075 Shelys Pharmaceuticals Limited, Tanzania Silver Sulfadiazine P Cream Topical 134/076 Shelys Pharmaceuticals Limited, Tanzania Burnox Cream 1.0%w/w + 5157 Chlorhexidine 0.2%w/w Clobetasone 0.05%w/w POM Cream Topical 134/077 Shelys Pharmaceuticals Limited, Tanzania + Gentamicin Sulphate Dermacin Cream 0.1%w/w + Miconazole 5158 10.0%w/w ORS + Zinc Sulphate P Powder for oral 134/078 Shelys Pharmaceuticals Limited, Tanzania Orazinc Kit 5159 20mg solution Diclofenac P Gel Topical 134/079 Shelys Pharmaceuticals Limited, Tanzania Diethylalamine Diclopar Activa Gel 1.16%w/w + Methyl Salycilate 10.00%w/w + 5160 Racementhol 5.00%w/w Miconazole Nitrate BP POM Cream Topical 134/080 Shelys Pharmaceuticals Limited, Tanzania Micosil Cream 5161 1%w/w

Page 267 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Benzathine Penicillin 2.4MU POM Powder for 212/001 Shijiazhvang Pharma Group, Zhonghuo Benzathine Penicillin 2.4g 5162 Injection Injection Pharmaceutical Co., Ltd, POM Powder for 212/002 Shijiazhvang Pharma Group, Zhonghuo Ampicillin Sodium Injection Ampicillin 1.0g 5163 Injection Pharmaceutical Co., Ltd, Ceftriaxone Sodium Injection Cefriaxone 1.0g POM Powder for 212/003 Shijiazhvang Pharma Group, Zhonghuo 5164 Injection Pharmaceutical Co., Ltd, Benzathine Penicillin 2.4MU Benzathine Penicillin POM Powder for 212/006 Shijiazhvang Pharma Group, Zhonghuo 5165 Injection 2.4MU Injection Pharmaceutical Co., Ltd, Cefotaxime Sodium 1g For POM Powder for 212/007 Shijiazhvang Pharma Group, Zhonghuo Cefotaxime Sodium 1g 5166 Injection Injection Pharmaceutical Co., Ltd, Chloramphenicol POM Eye Drops 143/003 Shreechem Pharmaceuticals (Pvt) Ltd, Cichlor Eye Drops 5167 0.5%w/v India POM Solution for 143/004 Shreechem Pharmaceuticals (Pvt) Ltd, Vitamin B Complex Injection Vitamin B Complex 5168 Injection India Aluminium Hydroxide + P Tablet Uncoated 143/005 Shreechem Pharmaceuticals (Pvt) Ltd, Sangel Tablets 5169 Magnesium Trisilicate India GS Tablet Uncoated 143/006 Shreechem Pharmaceuticals (Pvt) Ltd, Multivitamins Tablets Multivitamins 5170 India Sulphadoxine 500mg + P Tablet Uncoated 143/007 Shreechem Pharmaceuticals (Pvt) Ltd, Maxinfen Tablets 5171 Pyrimethamine 25mg India POM Capsule oral 143/008 Shreechem Pharmaceuticals (Pvt) Ltd, Ciphenicol 250 Capsules Chloramphenicol 250mg 5172 India P Tablet Uncoated 143/009 Shreechem Pharmaceuticals (Pvt) Ltd, Apetito Tablets Cyproheptadine 4mg 5173 India Paracetamol 325mg + P Capsule oral 143/010 Shreechem Pharmaceuticals (Pvt) Ltd, Bumol Capsules Ibuprofen 200mg + India 5174 Caffeine 25mg P Tablet Uncoated 143/011 Shreechem Pharmaceuticals (Pvt) Ltd, Deworm Tablets Mebendazole 100mg 5175 India POM Solution for 143/012 Shreechem Pharmaceuticals (Pvt) Ltd, Lignocaine Injection Lignocaine 2%w/w 5176 Injection India GS Tablet Uncoated 143/013 Shreechem Pharmaceuticals (Pvt) Ltd, Cimol Tablets Paracetamol 500mg 5177 India GS Tablet Uncoated 143/014 Shreechem Pharmaceuticals (Pvt) Ltd, Chaptone Extra Tablets Multivitamins 5178 India POM Tablet Uncoated 143/015 Shreechem Pharmaceuticals (Pvt) Ltd, Ceagra Tablets Sildenafil 50mg 5179 India P Ointment topical 143/016 Shreechem Pharmaceuticals (Pvt) Ltd, Chapsulf Ointment Precipitated Sulphur 10% 5180 India

Page 268 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER P Capsule oral 143/017 Shreechem Pharmaceuticals (Pvt) Ltd, Cindo-25 Capsules Indomethacin 25mg 5181 India P Tablet Uncoated 143/018 Shreechem Pharmaceuticals (Pvt) Ltd, Cibufen-200 Tablets Ibuprofen 200mg 5182 India GS Tablet Uncoated 143/019 Shreechem Pharmaceuticals (Pvt) Ltd, Chapvit Tablets Multivitamins 5183 India Chlorpheniramine BP P Tablet Uncoated 143/020 Shreechem Pharmaceuticals (Pvt) Ltd, 2mg + Paracetamol BP India Clearcold Tablets 500mg + Caffeine 5184 (Anhydrous) BP 30mg 5185 Misotac Tablets Misoprostol 0.2mg POM Tablet Uncoated 107/001 Sigma Pharmaceuticals Ltd, Egypt POM Tablet Film coated 351/001 SIGMA-TAU INDUSTRIE Piperaquine FARMACEUTICHE RIUNITE S.P.A Eurartesim 320/40 Tablets Tetraphosphate 320mg + Dihydroartemesinin 40mg 5186 POM Tablet Film coated 351/002 SIGMA-TAU INDUSTRIE Piperaquine FARMACEUTICHE RIUNITE S.P.A Eurartesim 160/20 Tablets Tetraphosphate 160mg + Dihydroartemesinin 20mg 5187 5188 Frusemide Tablets Frusemide 40mg POM Tablet Uncoated 151/051 SK Age Exports, India 5189 Amoxykant 250 Capsules Amoxicillin 250mg POM Capsule oral 162/005 SK Age Exports, India 5190 Metronol Tablets Metronidazole 200mg POM Tablet Uncoated 162/007 SK Age Exports, India 5191 Melquin 250 Tablets Erythromycin 250mg POM Tablet Uncoated 161/003 SKant Healthcare Ltd, India Pyrimethamine 25mg + P Tablet Uncoated 161/004 SKant Healthcare Ltd, India Malacure Tablets 5192 Sulphadoxine 500mg 5193 Amoxykant Capsules Amoxycillin 250mg POM Capsule oral 161/005 SKant Healthcare Ltd, India Promethazine Hydrochloride Promethazine 25mg, per POM Solution for 161/006 SKant Healthcare Ltd, India 5194 Injection 2ml Injection POM Solution for 161/007 SKant Healthcare Ltd, India Gentamycin Injection Gentamycin 40mg, per ml 5195 Injection Metronidazole 125mg, POM Suspension for 161/009 SKant Healthcare Ltd, India Metronikant Suspension 5196 per 5ml Oral Use Sulphamethoxazole POM Suspension for 161/010 SKant Healthcare Ltd, India Cotrikant Oral Suspension 200mg + Trimethoprim Oral Use 5197 40mg 5198 Paracetamol Tablets Paracetamol 500mg GS Tablet Uncoated 161/011 SKant Healthcare Ltd, India 5199 Salbukant 4 Tablets Salbutamol 4mg POM Tablet Uncoated 161/013 SKant Healthcare Ltd, India

Page 269 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Sulphamethoxazole POM Tablet Uncoated 161/014 SKant Healthcare Ltd, India Cotrikant Tablets 400mg + Trimethoprim 5200 80mg 5201 Ampikant Capsules Ampicillin 250mg POM Capsule oral 161/015 SKant Healthcare Ltd, India 5202 Ibukant Tablets Ibuprofen 200mg BP P Tablet Uncoated 161/016 SKant Healthcare Ltd, India Erythromycin 125mg, per POM Suspension 161/017 SKant Healthcare Ltd, India Erythrokant Suspension 5203 5ml 5204 Doxykant Capsules Doxycycline 250mg POM Capsule oral 161/018 SKant Healthcare Ltd, India Phenoxymethyl Penicillin Phenoxymethyl Penicillin POM Tablet Uncoated 161/019 SKant Healthcare Ltd, India 5205 Tablets V 250mg 5206 Cloxikant Capsules Cloxacillin 250mg POM Capsule oral 161/020 SKant Healthcare Ltd, India POM Capsule oral 161/021 SKant Healthcare Ltd, India Tetracycline Tetrakant Capsules Hydrochloride BP 250mg 5207 Cloxacillin 250mg + POM Capsule oral 161/022 SKant Healthcare Ltd, India Apicloxkant Capsules 5208 Ampicillin 250mg Acetyl Salicylic Acid P Tablet Uncoated 161/023 SKant Healthcare Ltd, India Aspikant Tablets 5209 300mg 5210 Metrokant Tablets Metronidazole 200mg POM Tablet Uncoated 161/024 SKant Healthcare Ltd, India Aluminium Hydrochloride GS Tablet Uncoated 161/025 SKant Healthcare Ltd, India Magtrikant Tablets 5211 + Magnesium Trisilicate 5212 CPkant Tablets Chlorpheniramine 2mg P Tablet Uncoated 161/026 SKant Healthcare Ltd, India 5213 Salbukant Syrup Salbutamol 2mg, per 5ml POM Syrup 161/027 SKant Healthcare Ltd, India Paracetamol 120mg, per GS Syrup 161/028 SKant Healthcare Ltd, India Parakant Syrup 5214 5ml Amoxicillin 125mg, per POM Syrup 161/029 SKant Healthcare Ltd, India Amoxykant Syrup 5215 5ml POM Powder for 161/030 SKant Healthcare Ltd, India Procaine Penicillin Injection Procain Penicillin 4MU 5216 Injection 5217 Diclokant Tablets Diclofenac 100mg P Tablet Uncoated 161/031 SKant Healthcare Ltd, India 5218 Cimetidine 200 Tablets Cimetidine 200mg POM Tablet Uncoated 161/032 SKant Healthcare Ltd, India 5219 Cimetidine 400 Tablets Cimetidine 400mg POM Tablet Uncoated 161/033 SKant Healthcare Ltd, India Sodium Chloride + GS Powder for Oral 161/034 SKant Healthcare Ltd, India Sodium Citrate + Solution Oral Rehydration Salts Potassium Chloride + 5220 Glucose Cloxacillin 250mg + POM Capsule oral 161/036 SKant Healthcare Ltd, India Apiclockant Capsules 5221 Ampicillin 250mg

Page 270 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Ferrous Sulphate + Folic P Tablet Uncoated 161/037 SKant Healthcare Ltd, India Ferrous+ Folic Acid Tablets 5222 Acid 5223 Nalikant Tablets Nalidixic Acid 500mg POM Tablet Uncoated 161/038 SKant Healthcare Ltd, India 5224 Aminophyline Tablets Aminophylline 100mg POM Tablet Uncoated 161/039 SKant Healthcare Ltd, India 5225 Prazikant Tablets Praziquantel 600mg POM Tablet Uncoated 161/040 SKant Healthcare Ltd, India 5226 Mebekant Tablets Mebendazole 100mg P Tablet Uncoated 161/041 SKant Healthcare Ltd, India POM Powder for 161/042 SKant Healthcare Ltd, India Ampicillin Injection Ampicillin 1000mg 5227 Injection 5228 Ciprokant 250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 161/043 SKant Healthcare Ltd, India 5229 Meldol Tablets Paracetamol 500mg GS Tablet Uncoated 161/044 SKant Healthcare Ltd, India 5230 Painrid Capsules Paracetamol + Caffeine GS Capsule oral 161/045 SKant Healthcare Ltd, India Paracetamol + Caffeine + P Tablet Uncoated 161/046 SKant Healthcare Ltd, India Coldnil Tablets 5231 Chlorpheniramine Dried Aluminium GS Tablet Uncoated 161/047 SKant Healthcare Ltd, India Melcid Tablets Hydroxide + Magnesium 5232 Trisilicate 5233 Melkoff Tablets Combination P Tablet Uncoated 161/048 SKant Healthcare Ltd, India 5234 Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 161/049 SKant Healthcare Ltd, India Ferric Ammonium Citrate P Syrup 161/050 SKant Healthcare Ltd, India 204mg + Cyanocobalamine 0.100mg + Pyridoxine Hematonic Hydrochloride 0.600mg + Folic Acid 1.800mg + Zinc Sulphate Monohydrate 1.455mg, 5235 per 5ml 5236 Good Night Syrup Combination P Syrup 161/052 SKant Healthcare Ltd, India 5237 Propranolol Tablets Propranolol 40mg POM Tablet Uncoated 161/053 SKant Healthcare Ltd, India 5238 Methyldopa Tablets Methyldopa 250mg POM Tablet Uncoated 161/054 SKant Healthcare Ltd, India 5239 Pyrazinamide Tablets Pyrazinamide 500mg POM Tablet Uncoated 161/055 SKant Healthcare Ltd, India 5240 Erythrokant Tablets Erythromycin 250mg POM Tablet Uncoated 161/056 SKant Healthcare Ltd, India 5241 Folicant 5 Tablets Folic Acid 5mg P Tablet Uncoated 161/057 SKant Healthcare Ltd, India 5242 Tetrakant 250 Capsules Tetracycline 250mg POM Capsule oral 161/058 SKant Healthcare Ltd, India 5243 Ibuprofen Tablets Ibuprofen 200mg P Tablet Film coated 161/059 SKant Healthcare Ltd, India 5244 Quinine Sulphate Tablets BP Quinine Sulphate 300mg POM Tablet Film coated 161/060 SKant Healthcare Ltd, India Arthemether + Lumefantrine Artemether 20mg + POM Tablet Uncoated 161/061 SKant Healthcare Ltd, India 5245 Tablets Lumefantrine 120mg

Page 271 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Nystatin Vaginal Insert USP POM Tablet Vaginal 161/062 SKant Healthcare Ltd, India Nystatin USP 100 000IU 5246 1000IU Silver Sulfadiazine USP POM Cream topical 161/063 SKant Healthcare Ltd, India Silverkant Cream 5247 1%w/w Ferric Ammonium Citrate POM Syrup 161/064 SKant Healthcare Ltd, India 204mg + Cyanocobalamine 0.100mg + Pyridoxine Hcl Hematonic Syrup 0.600mg + Folic Acid 1.800mg + Zinc Sulphate Monohydrate 1.455mg, 5248 per 5ml Diclofenac P Gel Topical 161/065 SKant Healthcare Ltd, India Dimethylamine 1.16% w/w + Oleum Lini 1%w/w Go Gel + Menthol BP 5%w/w + Mathyl Salicylate 10% + Capsaicin USP 5249 0.025%w/w POM Tablet Uncoated 125/001 Soceity For Family Health Ltd, Zambia Ethinylestradiol 0.03mg + Safe Plan Family Planning Pills Levonorgestrel 0.15mg + Ferrous Fumurate 75mg 5250 Medroxyprogesterone POM Solution for 125/002 Society for Family Health Ltd, Zambia My Choice Injection 5251 150mg, per ml Injection Ethinyl Estradiol 0.03mg POM Tablet Uncoated 125/003 Society for Family Health Ltd, Zambia Mychoice Microgynon Ed Fe + Levonorgestrel 0.15mg Tablets + Ferrous Fumurate 5252 75mg Mychoice Intra Uterine N/A Intra Uterine 125/004 Society for Family Health Ltd, Zambia Copper-T Cu 380 A 5253 Contraceptive Device 5254 Mychoice Woman Condom Latex Products GS Latex Products 125/005L Society for Family Health Ltd, Zambia 5255 Mychoice Diaphragm Latex Products GS Latex Products 125/006L Society for Family Health Ltd, Zambia 5256 Mychoice Lubricant Lubricant GS Gel Topical 125/007L Society for Family Health Ltd, Zambia 5257 Trust Studed Condom Male Latex Condom GS Latex Products 125/008L Society for Family Health Ltd, Zambia 5258 Trust Smooth Condom Male Latex Condom GS Latex Products 125/009L Society for Family Health Ltd, Zambia 5259 Cloxispa Capsules Cloxacillin 250mg POM Capsule oral 231/001 Sparsh Biotech Pvt Ltd, India 5260 Spamcil Capsules Ampicillin 250mg POM Capsule oral 231/002 Sparsh Biotech Pvt Ltd, India 5261 Spmox Capsules Amoxicillin 250mg POM Capsule oral 231/003 Sparsh Biotech Pvt Ltd, India

Page 272 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Phenoxymethyl Penicillin POM Tablet Uncoated 231/004 Sparsh Biotech Pvt Ltd, India Speniv Tablets 5262 V 250mg Phenoxymethyl Penicillin POM Powder for Oral 231/005 Sparsh Biotech Pvt Ltd, India Speniv Oral Suspension 5263 V 125mg, per 5ml Suspension Ampicillin 250mg + POM Capsule oral 231/006 Sparsh Biotech Pvt Ltd, India Spamox Capsules 5264 Cloxacillin 250mg 5265 Spamox Dispersible Tablets Amoxicillin 250mg POM Tablet Dispersible 231/007 Sparsh Biotech Pvt Ltd, India 5266 Hibiscrub Topical Solution Chlorhexidine 4.0%w/v GS Solution Topical 023/005 SSL International, England 5267 Hibitane 5% Concentrate Chlorhexidine 5% GS Solution Topical 023/006 SSL International, England GS Solution Topical 023/016 SSL International, England Hibiscet Hospital Concentration Chlorhexidine 40% 5268 POM Tablet Uncoated 039/030 Stada Vietnam Joint Venture Co. Ltd, Esoz 40 Tablets Esomeprazole 40mg 5269 Vietnam Ampicillin 250mg + POM Capsule oral 016/001 Stallion Laboratories Limited, India Stalclox Capsules 5270 Cloxacillin 250mg 5271 Cedril-250 Tablets Cefadroxil 250mg POM Tablet Uncoated 016/002 Stallion Laboratories Limited, India Ispaghula Husk 3.5g P Powder for Oral 016/003 Stallion Laboratories Limited, India Endulax Powder 5272 100% w/w Suspension 5273 Ole-400 Tablets Ofloxacin 400mg POM Tablet Uncoated 016/004 Stallion Laboratories Limited, India 5274 Ciptid-500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 016/005 Stallion Laboratories Limited, India Sulphadoxine 500mg + P Tablet Uncoated 016/006 Stallion Laboratories Limited, India Stalfin Tablets 5275 Pyrimethamine 25mg POM Capsule Sustained 016/007 Stallion Laboratories Limited, India P-Cam 20 Caspules Piroxicam 20mg 5276 Release 5277 Endulx Garlic Tablets Ispaghula Husk 300mg P Tablet Uncoated 016/008 Stallion Laboratories Limited, India 5278 Quinlin-300 Tablets Quinine 300mg POM Tablet Uncoated 016/009 Stallion Laboratories Limited, India 5279 Endulax Karela Capsules Ispaghula Husk 400mg P Capsule oral 016/010 Stallion Laboratories Limited, India Albendazole 23mg, per P Suspension for 122/711 Star Laboratories Pvt Ltd, Pakistan Alvenax Drench 1000ml 5280 ml Oral Use Oxytetracycline 40mg + P Spray for Topical 122/712 Star Laboratories Pvt Ltd, Pakistan Teragen Aerosol Spray 5281 Gentian Violet 4mg Use POM Solution for 122/713 Star Laboratories Pvt Ltd, Pakistan Tylomac Injection 100ml Tylosin 200mg, per ml 5282 Injection POM Solution for 122/714 Star Laboratories Pvt Ltd, Pakistan Amino Vital Injection 100mls Multivitamin 5283 Injection Povidone Iodine P Ointment topical 208/002 Stedman Pharmaceuticals (Pvt) Litd, India Drez Ointment 5.0%w/w + Metronidazole 5284 1.0%w/w

Page 273 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Povidone Iodine 5.0%w/w P Powder for Topical 208/003 Stedman Pharmaceuticals (Pvt) Litd, India Drez Powder + Metronidazole Solution 5285 1.0%w/w Povidone Iodine P Solution for Topical 208/004 Stedman Pharmaceuticals (Pvt) Litd, India Drez Solution 5.0%w/w + Metronidazole Use 5286 1.0%w/w Chlorpheniramine 1mg + P Suspension for 208/005 Stedman Pharmaceuticals (Pvt) Litd, India Contus Plus Paediatric Phenylephrine 5mg + Oral Use Suspension 5287 Paracetamol 160mg Chlorpheniramine 1mg + P Solution for Oral 208/006 Stedman Pharmaceuticals (Pvt) Litd, India Contus Paediatric linctus Phenylephrine 5mg + Use 5288 Dextromethophen 10mg Miconazole 1%w/w + POM Gel Vaginal 208/007 Stedman Pharmaceuticals (Pvt) Litd, India Drez-V Gel 5289 Metronidazole 100mg Chlorpheniramine 2mg + P Tablet Uncoated 208/008 Stedman Pharmaceuticals (Pvt) Litd, India Contus-650 Tablets Paracetamol 650mg + 5290 Phenylephrine 5mg 5291 STEDNAC Tablets Aceclofenac 100mg P Tablet Uncoated 208/009 Stedman Pharmaceuticals (Pvt) Litd, India Iodinated Povidone P Solution for Oral 208/010 Stedman Pharmaceuticals (Pvt) Litd, India DREZ Gargle 5292 2%w/v Use Tenofovir Disproxil Fumarate Tenofovir Disproxil POM Tablet Uncoated 090/030 Strides Arcolab Ltd, India 5293 300mg Tablet Fumarate 300mg Lamivudine + Zidovudine Lamivudine 150mg + POM Tablet Uncoated 090/001 Strides Shasun 5294 Tablets Zidovudine 300mg 5295 Stavudine Capsules Stavudine 30mg POM Capsule oral 090/002 Strides Shasun 5296 Efavirenz Tablets Efavirenz 600mg POM Tablet Uncoated 090/003 Strides Shasun Stavudine 30mg + POM Tablet Uncoated 090/004 Strides Shasun Stavudine + Lamivudine + Lamivudine 150mg + Nevirapine Tablets 5297 Nevirapine 200mg Stavudine 30mg + POM Tablet Uncoated 090/005 Strides Shasun Stavudine + Lamivudine Tablets 5298 Lamivudine 150mg POM Tablet Uncoated 090/006 Strides Shasun Abacavir Sulphate Tablets Abacavir Sulphate 300mg 5299 5300 Lamivudine Tablets Lamivudine USP 300mg POM Tablet Uncoated 090/007 Strides Shasun 5301 Pyrazinamide Tablets Pyrazinamide 400mg POM Tablet Uncoated 090/008 Strides Shasun Rifampicin 60mg + POM Tablet Dispersible 090/009 Strides Shasun Rifampicin & Isoniazid Tablets 5302 Isoniazid 30mg Ampicillin 250mg + POM Capsule oral 090/010 Strides Shasun Simclox -500 Capsules 5303 Cloxacillin 250mg

Page 274 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Hyoscine Butylbromide POM Tablet Film coated 090/013 Strides Shasun Hyosim Tablets 5304 10mg 5305 Griseosim - 500 Tablets Griseofulvin 500mg POM Tablet Uncoated 090/014 Strides Shasun 5306 Mebrone -100 Tablets Mebendazole 100mg P Tablet Uncoated 090/015 Strides Shasun 5307 Nalidixic Acid Tablets Nalidixic Acid 500mg P Tablet Uncoated 090/016 Strides Shasun 5308 Cefalexin - 500 Capsules Cefalexin 500mg POM Capsule oral 090/017 Strides Shasun Ceftriaxone Sodium USP POM Powder for 090/018 Strides Shasun Celltriaxone Injection 5309 1g Injection Ferric Ammonium Citrate P Syrup 090/019 Strides Shasun USP 200mg (Equivalent To Elemental Iron 41mg) Vitafer Forte Syrup Folic Acid BP 1.5mg + Vitamin B12 BP 50mcg, 5310 per 5ml) 5311 Lorhist Tablets Loratadine USP 10mg POM Tablet Uncoated 090/020 Strides Shasun 5312 Melonax 15 Tablets Meloxicam 15mg BP POM Tablet Film coated 090/021 Strides Shasun 5313 Camvit -Plus Capsules Multivitamins & Minerals P Capsule oral 090/022 Strides Shasun 5314 Efavirenz Tablets Efavirenz 200mg POM Tablet Uncoated 090/023 Strides Shasun Amoxicillin Dry Powder For POM powder for syrup 286/001 Strides Shasun Amoxicillin 125mg 5315 Syrup 125mg/5ml 5316 Indomethacin Capsules 25mg Indomethacin 25mg P Capsule oral 286/004 Strides Shasun 5317 Apirone 250mg Capsules Ampicillin 250mg POM Capsule oral 286/005 Strides Shasun 5318 Cloxacillin 250mg Capsules Cloxacillin 250mg POM Capsule oral 286/006 Strides Shasun 5319 Tetracycline 250mg Capsules Tetracycline 250mg POM Capsule oral 286/008 Strides Shasun 5320 Vitamin C Tablets Ascorbic Acid P Tablet 286/009 Strides Shasun Cloxacillin Dry Powder For POM powder for syrup 286/010 Strides Shasun Cloxacillin 125mg 5321 Syrup 125mg/5ml POM powder for syrup 286/013 Strides Shasun Co-trimoxazole Dry Powder For Sulfamethoxazole 200mg Syrup 240mg/5ml + Trimethoprim 40mg 5322 Mifepristone 200mg + POM Tablet Uncoated 083/001 Sun Pharmaceticals Limited Medabon Tablets 5323 Misoprostol 200mcg 5324 Sporidex 500 Capsules Cephalexin 500mg POM Capsule oral 112/001 Sun Pharmaceutical Industries Limited 5325 Sporidex Capsules Cephalexin 250mg POM Capsule oral 112/002 Sun Pharmaceutical Industries Limited 5326 Simvor 10 Tablets Simvastatin 10mg POM Tablet Film coated 112/003 Sun Pharmaceutical Industries Limited 5327 Simvor 20 Tablets Simvastatin 20mg POM Tablet Film coated 112/004 Sun Pharmaceutical Industries Limited Vitamin B3 + Calcium P Tablet Film coated 112/005 Sun Pharmaceutical Industries Limited Effical Tablets 5328 Carbonate

Page 275 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Amoxicillin 1000mg + POM Solution for 112/007 Sun Pharmaceutical Industries Limited Enhancin Injection Clavulanate Potassium Injection 5329 200mg 5330 Canova-50 Tablets Sildenafil 50mg POM Tablet Uncoated 112/009 Sun Pharmaceutical Industries Limited 5331 Fluroric 50 Capsules Fluconazole 50mg POM Capsule oral 112/012 Sun Pharmaceutical Industries Limited 5332 Fluroric 150 Capsules Fluconazole 150mg POM Capsule oral 112/013 Sun Pharmaceutical Industries Limited Chlorhexidine + Silver P Cream Topical 112/016 Sun Pharmaceutical Industries Limited Silverex Cream 5333 Sulfadiazine Race Menthol + Methyl P Gel Topical 112/018 Sun Pharmaceutical Industries Limited Volini Gel Salicylate + Diclofenac + 5334 Linse 5335 Storvas 20mg Tablets Atorvastatin 20mg POM Tablet Film coated 112/023 Sun Pharmaceutical Industries Limited 5336 Storvas 10mg Tablets Atorvastatin 10mg POM Tablet Film coated 112/024 Sun Pharmaceutical Industries Limited 5337 Ranophage 500mg Tablets Metformin 500mg POM Tablet Uncoated 112/025 Sun Pharmaceutical Industries Limited Amoxicillin 875mg + POM Tablet Film coated 112/026 Sun Pharmaceutical Industries Limited Enhancin 1000 Tablets Clavulanate Potassium 5338 125mg 5339 Amlovas Tablets Amlodipine 10mg POM Tablet Uncoated 112/027 Sun Pharmaceutical Industries Limited Cefuroxime 125mg, per POM Suspension for 112/028 Sun Pharmaceutical Industries Limited Ceroxim 125mg/5ml Suspension 5340 5ml Oral Use Cefuroxime 250mg, per POM Suspension for 112/029 Sun Pharmaceutical Industries Limited Ceroxim 250mg/5ml Suspension 5341 5ml Oral Use 5342 Flucoric 100mg Capsules Fluconazole 100mg POM Capsule oral 112/030 Sun Pharmaceutical Industries Limited 5343 Klabax Tablets Clarithromycin 250mg POM Tablet Film coated 112/031 Sun Pharmaceutical Industries Limited 5344 Klabax 500 Tablets Clarithromycin 500mg POM Tablet Film coated 112/032 Sun Pharmaceutical Industries Limited 5345 Flucoric Capsules Fluconazole 200mg POM Capsule oral 112/033 Sun Pharmaceutical Industries Limited Ranmoxy 125 Suspension POM Suspension for 112/035 Sun Pharmaceutical Industries Limited Amoxicillin 125mg 5346 125mg Oral Use 5347 Cifran OD Tablets Ciprofloxacin 1g POM Tablet Uncoated 112/036 Sun Pharmaceutical Industries Limited 5348 Cifran OD Tablets Ciprofloxacin 500mg POM Tablet Uncoated 112/037 Sun Pharmaceutical Industries Limited POM Powder for 112/040 Sun Pharmaceutical Industries Limited Oframax 250 Injection Ceftriaxone 250mg 5349 Injection POM Powder for 112/041 Sun Pharmaceutical Industries Limited Oframax Injection Ceftriaxone 1000mg 5350 Injection P Capsule oral 112/042 Sun Pharmaceutical Industries Limited Ferrous Fumarate 305mg + Ascorbic Acid 75mg + Ranferon - 12 Capsules Cyanocobalamine 5mcg + Foilc Acid 0.75mg 5351

Page 276 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER POM Solution for 112/046 Sun Pharmaceutical Industries Limited Loxof Infusion Levofloxacin 5mg, per ml 5352 infusion 5353 Avostav 30 Capsules Stavudine 30mg POM Capsule oral 112/047 Sun Pharmaceutical Industries Limited 5354 Loxf-250 Tablets Levofloxacin 250mg POM Tablet Film coated 112/049 Sun Pharmaceutical Industries Limited 5355 Loxof 500 Tablets Levofloxacin 500mg POM Tablet Film coated 112/050 Sun Pharmaceutical Industries Limited Sulphamethoxazole POM Suspension for 112/051 Sun Pharmaceutical Industries Limited Rancotrim Suspension 200mg + Trimethoprim Oral Use 5356 40mg, per 5ml 5357 Copril Capsules Ramipril 5mg POM Capsule oral 112/054 Sun Pharmaceutical Industries Limited 5358 Amlovas Tablets Amlodipine 5mg POM Tablet Uncoated 112/055 Sun Pharmaceutical Industries Limited Cilastatin 500mg + POM Solution for 112/056 Sun Pharmaceutical Industries Limited Bacqure 50 Injection 5359 Imipenem 500mg Injection 5360 Contiflo 0.4 Capsules Tamsulosin 0.4mg POM Capsule oral 112/057 Sun Pharmaceutical Industries Limited 5361 Avolam Tablets Lamivudine 150mg POM Tablet Uncoated 112/058 Sun Pharmaceutical Industries Limited Lamivudine 150mg + POM Tablet Uncoated 112/059 Sun Pharmaceutical Industries Limited Avocomb Tablets 5362 Zidovudine 300mg Lamivudine 150mg + POM Tablet Uncoated 112/060 Sun Pharmaceutical Industries Limited Avocomb-N Tablets Nevirapine 200mg + 5363 Zidovudine 300mg 5364 Abac 300 Tablets Abacavir 300mg POM Tablet Uncoated 112/061 Sun Pharmaceutical Industries Limited 5365 Aviro-Z Tablets Zidovudine 300mg POM Tablet Uncoated 112/062 Sun Pharmaceutical Industries Limited 5366 Nevipan Tablets Nevirapine 200mg POM Tablet Uncoated 112/063 Sun Pharmaceutical Industries Limited 5367 Histac EVT 150 Tablets Ranitidine 150mg POM Tablet Uncoated 112/068 Sun Pharmaceutical Industries Limited Amoxicillin 250mg + POM Tablet Uncoated 112/069 Sun Pharmaceutical Industries Limited Enhancin 375 Tablets Clavulanate Potassium 5368 125mg Amoxicillin 500mg + POM Tablet Uncoated 112/070 Sun Pharmaceutical Industries Limited Enhancin 625 Tablets Clavulanate Potassium 5369 125mg Cephalexin 125mg, per POM Suspension for 112/071 Sun Pharmaceutical Industries Limited Sporidex Suspension 5370 5ml Oral Use Stavudine 30mg + POM Tablet Uncoated 112/073 Sun Pharmaceutical Industries Limited Triviro 30 --LNS Tablets Nevirapine 200mg + 5371 Lamivudine 150mg Stavudine 40mg + POM Tablet Uncoated 112/074 Sun Pharmaceutical Industries Limited Triviro 40 -LNS Tablets Nevirapine 200mg + 5372 Lamivudine 150mg Coviro-LS 30 Compliance Pack Lamivudine 150mg + POM Tablet Uncoated 112/075 Sun Pharmaceutical Industries Limited 5373 Tablets Stavudine 30mg

Page 277 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Coviro-LS 40 Compliance Pack Lamivudine 150mg + POM Tablet Uncoated 112/076 Sun Pharmaceutical Industries Limited 5374 Tablets Stavudine 40mg Abacavir 300mg + POM Tablet Uncoated 112/077 Sun Pharmaceutical Industries Limited Abac-LZ Tablets Lamivudine 150mg + 5375 Zidovudine 300mg 5376 Avirodin Capsules Indinavir 400mg POM Capsule oral 112/078 Sun Pharmaceutical Industries Limited 5377 Aviranz 600 Tablets Efavirenz 600mg POM Tablet Uncoated 112/079 Sun Pharmaceutical Industries Limited 5378 Aviranz 200 Tablets Efavirenz 200mg POM Tablet Uncoated 112/080 Sun Pharmaceutical Industries Limited Chlorpheniramine 2mg + P Syrup 112/081 Sun Pharmaceutical Industries Limited Dextrometherphan 10mg Chericoff Syrup + Phenylephrine 5mg, 5379 per 5ml Ciprofloxacin 500mg + POM Tablet Uncoated 112/082 Sun Pharmaceutical Industries Limited Cifran C.T Tablets 5380 Tinidazole 600mg 5381 Riconia Liquid Multivitamins GS Syrup 112/083 Sun Pharmaceutical Industries Limited 5382 Sebifin Tablets Terbinafine 250mg POM Tablet Uncoated 112/084 Sun Pharmaceutical Industries Limited 5383 Riconia Tablets Multivitamins GS Tablet Uncoated 112/085 Sun Pharmaceutical Industries Limited 5384 Monsin Ointment Mupirocin 2.0%w/w POM Ointment topical 112/086 Sun Pharmaceutical Industries Limited Cefpodoxime 40mg, per POM Suspension for 112/087 Sun Pharmaceutical Industries Limited Cepodem Suspension 5385 5ml Oral Use 5386 Cepodem 200mg Tablets Cefpodoxime 200mg POM Tablet Uncoated 112/088 Sun Pharmaceutical Industries Limited 5387 Ranophage 1000mg Tablets Metformin 1000mg POM Tablet Uncoated 112/089 Sun Pharmaceutical Industries Limited 5388 Cepodem 100mg Tablets Cefpodoxime 100mg POM Tablet Uncoated 112/090 Sun Pharmaceutical Industries Limited Paracetamol 375mg + P Tablet Film coated 112/091 Sun Pharmaceutical Industries Limited Brustan Tablets 5389 Ibuprofen 200mg Paracetamol 125mg + P Suspension for 112/092 Sun Pharmaceutical Industries Limited Brustan Suspension 5390 Ibuprofen 100mg Oral Use 5391 Corpril 2.5 Tablets Ramipril 2.5mg POM Tablet Uncoated 112/093 Sun Pharmaceutical Industries Limited 5392 Corpril 10 Tablets Ramipril 10mg POM Tablet Uncoated 112/094 Sun Pharmaceutical Industries Limited Lamivudine 150mg + POM Tablet Uncoated 112/095 Sun Pharmaceutical Industries Limited Avocomb-E Compliance Pack Zidovudine 300mg + Tablets 5393 Efavirenz 600mg Stavudine 30mg + POM Tablet Uncoated 112/096 Sun Pharmaceutical Industries Limited Coviro-E 30 Compliance Pack Lamivudine 150mg + Tablets 5394 Efavirenz 600mg Stavudine 10mg + POM Tablet Dispersible 112/098 Sun Pharmaceutical Industries Limited Triviro LNS Kid Dispersible Lamivudine 40mg + Tablets 5395 Nevirapine 70mg

Page 278 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Stavudine 5mg + POM Tablet Dispersible 112/099 Sun Pharmaceutical Industries Limited Triviro LNS Kid Dispersible Lamivudine 20mg + Tablets 5396 Nevirapine 35mg 5397 Ranferon-12 Syrup Haematinic Preparation P Syrup 112/100 Sun Pharmaceutical Industries Limited Amoxicillin 125mg + POM Suspension for 112/101 Sun Pharmaceutical Industries Limited Enhancin Suspension Clavulanic Acid 31.25mg, Oral Use 5398 per 5ml 5399 Lovir Cream Acyclovir 5% POM Cream Topical 112/102 Sun Pharmaceutical Industries Limited 5400 Klabax Suspension -12 Clarithromycin 125mg POM Suspension 112/103 Sun Pharmaceutical Industries Limited Ginseng + Multivitamin + GS Capsule 112/104 Sun Pharmaceutical Industries Limited Revital Capsules 5401 Mineral Fluticasone 0.05mg + POM Ointment topical 112/105 Sun Pharmaceutical Industries Limited Mucasone Ointment 5402 Mupirocin 20mg 5403 Relenost Tablets Alendronate 70mg POM Tablet Uncoated 112/106 Sun Pharmaceutical Industries Limited 5404 Raciper Tablets Esomeprazole 20mg POM Tablet Uncoated 112/107 Sun Pharmaceutical Industries Limited 5405 Amosec Tablets Secnidazole 1000mg POM Tablet Uncoated 112/108 Sun Pharmaceutical Industries Limited 5406 Rodera Tablets Desloratadine 5mg POM Tablet Uncoated 112/109 Sun Pharmaceutical Industries Limited 5407 Staval 80 Tablets Valsartan 80mg POM Tablet Uncoated 112/110 Sun Pharmaceutical Industries Limited 5408 Starval 16 Tablets Valsartan 160mg POM Tablet Uncoated 112/111 Sun Pharmaceutical Industries Limited Valsartan 80mg + POM Tablet Uncoated 112/112 Sun Pharmaceutical Industries Limited Starval HCT 80 + 12.5 Tablets Hydrochlorothiazide 5409 12.5mg Valsartan 160mg + POM Tablet Uncoated 112/113 Sun Pharmaceutical Industries Limited Starval HCT 160/25 Tablets Hydrochlorothiazide 5410 25mg 5411 Raciper 40 Tablets Esomeprazole 40mg POM Tablet Uncoated 112/114 Sun Pharmaceutical Industries Limited 5412 Romilast 10 Tablets Montelukast 10mg POM Tablet Uncoated 112/115 Sun Pharmaceutical Industries Limited 5413 Ceruvin Tablets Clopidogrel 75mg POM Tablet Uncoated 112/116 Sun Pharmaceutical Industries Limited Ibuprofen 5% + P Gel Topical 112/117 Sun Pharmaceutical Industries Limited Brustan Gel 5414 Levomenthol 3% 5415 Rosuvas 10 Tablets Rosuvastatin 10mg POM Tablet Uncoated 112/118 Sun Pharmaceutical Industries Limited 5416 Rosuvas 20 Tablets Rosuvastatin 20mg POM Tablet Uncoated 112/119 Sun Pharmaceutical Industries Limited 5417 Alyvir Tablets Valacyclovir 500mg POM Tablet Uncoated 112/120 Sun Pharmaceutical Industries Limited Glimepiride 1mg + POM Tablet Film coated 112/121 Sun Pharmaceutical Industries Limited Ranophage G1 Tablets 5418 Metformin 500mg Glimepiride 2mg + POM Tablet Film coated 112/122 Sun Pharmaceutical Industries Limited Ranophage G2 Tablets 5419 Metformin 500mg POM Powder for 112/123 Sun Pharmaceutical Industries Limited Bestinem 1000mg Injection Meropenem 1000mg 5420 Injection

Page 279 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Escitalopram Oxalate POM Tablet Uncoated 112/124 Sun Pharmaceutical Industries Limited Cilentra Tablets 5421 10mg Escitalopram Oxalate POM Tablet Uncoated 112/125 Sun Pharmaceutical Industries Limited Cilentra Tablets 5422 20mg 5423 Adosine 100 Tablets Didanosine 100mg POM Tablet Dispersible 112/126 Sun Pharmaceutical Industries Limited 5424 Adosine 50 Tablets Didanosine 50mg POM Tablet Dispersible 112/127 Sun Pharmaceutical Industries Limited 5425 Adosine 25 Tablets Didanosine 25mg POM Tablet Dispersible 112/128 Sun Pharmaceutical Industries Limited Olmesartan Medoxomil POM Tablet Film coated 112/129 Sun Pharmaceutical Industries Limited Olvance 20 Tablets 5426 20mg Olmesartan Medoxomil POM Tablet Film coated 112/130 Sun Pharmaceutical Industries Limited Olvance 40 Tablets 5427 40mg Olmesartan Medoxomil POM Tablet Film coated 112/131 Sun Pharmaceutical Industries Limited 20mg + Olvance HCT 20 Tablets Hydrochlorothiazide 5428 12.5mg Olmesartan Medoxomil POM Tablet Film coated 112/132 Sun Pharmaceutical Industries Limited 40mg + Olvance HCT 40 Tablets Hydrochlorothiazide 5429 12.5mg 5430 Suntel 40 Tablets Telmisartan 40mg POM Tablet Film coated 446/002 Sunberg Lifescience Ltd Clintrim SB Vaginal Clotrimazole 100mg + POM Vaginal 446/001 Sunberg Lifescience Ltd 5431 Suppositories Clindamycin 100mg suppositories POM Solution for 262/001 Sunny Impex Private Ltd, India Sterile Water For Injection Water For Injection 5432 Injection Sodium Chloride + GS Powder for Oral 262/002 Sunny Impex Private Ltd, India Sodium Citrate + Solution Oral Rehydrate Salts Potassium Chloride + 5433 Dextrose POM Solution for 056/001 Svizera Europe BV, The Netherlands Water For Injection Water For Injection 5434 Injection Rifampicin 150mg + POM Tablet Uncoated 056/002 Svizera Europe BV, The Netherlands Rifampicin + Isoniazid + Isoniazid 75mg + Pyrazinamide + Ethambutol Pyrazinamide 400mg + FDC Tablets 5435 Ethambutol 275mg Streptomycin Sulphate Powder POM Powder for 056/003 Svizera Europe BV, The Netherlands Streptomycin 1.0 Grams 5436 For Injection Injection Sulbactam 125mg + POM Solution for 131/002 T3A Pharma Group, Egypt Synerpen Injection 5437 Ampicillin 250mg Injection

Page 280 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Sulbactam 250mg + POM Solution for 131/003 T3A Pharma Group, Egypt Synerpen T3A Injection 5438 Ampicillin 500mg Injection Sulbactam 500mg + POM Solution for 131/004 T3A Pharma Group, Egypt Synerpen T3A Injection 5439 Ampicillin 1000mg Injection POM Solution for 131/005 T3A Pharma Group, Egypt Cefotax T3A Injection Cefotaxime 250mg 5440 Injection Gentamicin 80mg, per POM Solution for 238/001 Tablets (India) Ltd, India Bacticid Injection 5441 2ml Injection 5442 Ambrolite Syrup Ambroxol 30mg, per 5ml POM Syrup 238/002 Tablets (India) Ltd, India Dexamethasone Sodium POM Solution for 238/003 Tablets (India) Ltd, India Omnicort Injection 5443 Phosphate 4mg, per ml Injection P Syrup 238/004 Tablets (India) Ltd, India Ferrous Glycine Sulphate 220mg + Thiamine Ferup Syrup Hydrochloride BP 0.25mg + Cynocobalamin BP + Folic Acid 0.5mg 5444 POM Solution for 238/005 Tablets (India) Ltd, India Tilprome Injection Promethazine 25mg 5445 Injection 5446 Ednisol Tablets Prednisolone 5mg POM Tablet Uncoated 238/006 Tablets (India) Ltd, India 5447 Tocosules 400 Capsules Vitamin E 400mg POM Capsule 238/007 Tablets (India) Ltd, India P Powder for 238/008 Tablets (India) Ltd, India Astymin-3-200 Ml Injection Amino Acids 5448 Injection 5449 Tilzole Tablets Mebendazole 100mg P Tablet Uncoated 238/009 Tablets (India) Ltd, India 5450 Neutrosec Syrup Vitamins + Minerals P Syrup 238/010 Tablets (India) Ltd, India Ciprofloxacin 200mg, per POM Solution for 238/011 Tablets (India) Ltd, India Cifrotil Injection 5451 100ml infusion 5452 Statasmin-4 Tablets Salbutamol 4mg POM Tablet Uncoated 238/012 Tablets (India) Ltd, India 5453 Fevastin Tablets Paracetamol 500mg GS Tablet Uncoated 238/013 Tablets (India) Ltd, India Amino Acids And P Syrup 238/014 Tablets (India) Ltd, India Astymin Syrup 5454 Vitamins Neostigmine 0.5mg, per P Solution for 238/015 Tablets (India) Ltd, India Tilstigmin Injection 5455 ml injection 5456 Astymin Forte Capsules Amino Acids + Minerals P Capsule oral 238/017 Tablets (India) Ltd, India 5457 Tilprome Tablets Promethazine 25mg P Tablet Uncoated 238/018 Tablets (India) Ltd, India 5458 Tilvit Syrup Multivitamins GS Syrup 238/019 Tablets (India) Ltd, India P Solution for Oral 238/020 Tablets (India) Ltd, India Astyfer Liquid Haematic Preparation 5459 Use 5460 Antoxyl Forte Capsules Vitamins + Minerals P Capsule oral 238/021 Tablets (India) Ltd, India

Page 281 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Glucosamine 500mg + P Capsule oral 238/022 Tablets (India) Ltd, India Movactive Capsules 5461 Magnesium 2mg 5462 Profundin Tablets Ibuprofen 200mg P Tablet Uncoated 238/023 Tablets (India) Ltd, India 5463 Amedosix Tablets Furosemide 40mg POM Tablet Uncoated 238/024 Tablets (India) Ltd, India 5464 Trichogyl - 200 Tablets Metronidazole 200mg POM Tablet Uncoated 238/025 Tablets (India) Ltd, India POM Solution for 238/026 Tablets (India) Ltd, India Estyplex-5 Injection Vitamin B Complex 5465 Injection 5466 Promethazine Tablets Promethazine 10mg P Tablet Uncoated 238/027 Tablets (India) Ltd, India POM Solution for 238/028 Tablets (India) Ltd, India Trichogyl I.V. Injection Metronidazole 500mg 5467 infusion POM Solution for 238/029 Tablets (India) Ltd, India Amedosix -10 Injection Furosemide 10mg 5468 Injection Folic Acid + Iron + Vit B P Capsule oral 238/030 Tablets (India) Ltd, India Astyfer Capsules 5469 Complex + Amino Acids 5470 Cifrotil Tablets Ciprofloxacin 500mg POM Tablet Uncoated 238/031 Tablets (India) Ltd, India 5471 Tilvitone Tablets Vitamin B Complex P Tablet Uncoated 238/032 Tablets (India) Ltd, India Fluconazole 200mg, per POM Solution for 238/033 Tablets (India) Ltd, India Zoleshot 5472 ml infusion 5473 Omega 3 Capsules Minerals + Vitamins GS Capsules Oral 008/000HM Tasly(S.A) Pty Ltd, South Africa Tasly Nano Iron + Vitamin C Iron 11mg + Ascorbic GS Tablets 008/001 Tasly(S.A) Pty Ltd, South Africa 5474 Tablets Acid 100mg Propolis Beeglue CP GS Capsules oral 008/001HM Tasly(S.A) Pty Ltd, South Africa Miss Bee Propolis & Glossy 125mg + Spora Ganordema Capsules 5475 Gonaderma CP 125mg 5476 Tasly Sea Oil Capsules Cold Liver Oil 313mg GS Capsule oral 008/002HM Tasly(S.A) Pty Ltd, South Africa Quinese Cordceps GSL capsules 008/003HM Tasly(S.A) Pty Ltd, South Africa Kasly Cordyceps Capsules 5477 Powder White Peony Root GSL Tablets 008/004HM Tasly(S.A) Pty Ltd, South Africa Tasly Phyto Soy Tablets 5478 Extract, Soy Isoflavones 5479 Ginseng RH Capsules Radix Ginseng Powder GSL capsules 008/005 HM Tasly(S.A) Pty Ltd, South Africa GS Granules for Oral 008/006HM Tasly(S.A) Pty Ltd, South Africa Tasly Danshen Tea Herbal Extracts 1500mg 5480 Use Tasly Miss Bee Royal Jelly GS Capsule oral 008/007HM Tasly(S.A) Pty Ltd, South Africa Royal Jelly 500mg 5481 Capsules Tasly Miss Bee Propolis Soft GS Capsule oral 008/008HM Tasly(S.A) Pty Ltd, South Africa Bee Propolis 400mg 5482 Gel Camellia Pollen 500mg + GS Capsule oral 008/009HM Tasly(S.A) Pty Ltd, South Africa Tasly Miss Bee Camellia Bee 5483 Green Tea 100mg 5484 Tasly AL Capsules Herbal Extracts 400mg GS Capsule oral 008/010HM Tasly(S.A) Pty Ltd, South Africa

Page 282 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 5485 Tasly Propolis Syrup Bee Propolis GS Syrup 008/011HM Tasly(S.A) Pty Ltd, South Africa Tasly Miss Bee Propolis + GS Capsule oral 008/012HM Tasly(S.A) Pty Ltd, South Africa Bee Propolis 500mg 5486 Water Pollen Capsule 5487 Tasly Kings Capsules Herbal Extracts 300mg GS Capsule oral 008/013HM Tasly(S.A) Pty Ltd, South Africa Tasly Bitter Melon Powder Bitter Melon Extract GS Capsule oral 008/014HM Tasly(S.A) Pty Ltd, South Africa 5488 Capsules 500mg 5489 Tasly Amical Capsules Amino Acids P Capsule oral 008/015 Tasly(S.A) Pty Ltd, South Africa 5490 Tasly Glucare Capsules Herbal Extracts 500mg GS Capsule oral 008/015HM Tasly(S.A) Pty Ltd, South Africa 5491 Tasly Milk Calcium Tablets Milk Calcium + Vitamins P Tablet Uncoated 008/016 Tasly(S.A) Pty Ltd, South Africa Tasly Nano Tammy Relief GS Powder for Oral 008/016HM Tasly(S.A) Pty Ltd, South Africa Herbal Extracts 5492 Powder Use 5493 Tasly Colim Forte Tablets B Complex P Tablet Uncoated 008/017 Tasly(S.A) Pty Ltd, South Africa GS Granules for Oral 008/017HM Tasly(S.A) Pty Ltd, South Africa Tasly Cerebralcare Granules Herbal Extracts 5494 Use 5495 Tasly Cen Forte Tablets Vitamins + Minerals P Tablet Uncoated 008/018 Tasly(S.A) Pty Ltd, South Africa 5496 Tasly Citrus Sour Tablets Herbal Extracts GS Tablet Uncoated 008/019 Tasly(S.A) Pty Ltd, South Africa 5497 Tasly I- Cleansing Capsules Herbal Extracts GS Capsule oral 008/019HM Tasly(S.A) Pty Ltd, South Africa 5498 Tasly Red Yeast Tablets Red Yeast Rice Extract GS Tablet Uncoated 008/020 Tasly(S.A) Pty Ltd, South Africa POM Solution for 147/001 Tejay Pharmaceuticals Limited Adrenalline Injection Adrenalline 1mg, per ml 5499 Injection POM Solution for 147/002 Tejay Pharmaceuticals Limited Atropine Injection Atropine 0.6mg, per ml 5500 Injection Amonophylline 25mg, per POM Solution for 147/003 Tejay Pharmaceuticals Limited Amonophylline Injection 5501 ml Injection Chlorpromazine 25mg, POM Solution for 147/004 Tejay Pharmaceuticals Limited Chlorpromazine Injection 5502 per ml Injection POM Solution for 147/005 Tejay Pharmaceuticals Limited Diazepam Injection Diazepam 5mg, per ml 5503 Injection POM Solution for 147/006 Tejay Pharmaceuticals Limited Furosemide Injection Furosemide 10mg, per ml 5504 Injection POM Solution for 147/007 Tejay Pharmaceuticals Limited Gentamycin Injection Gentamycin Injection 5505 Injection POM Solution for 147/008 Tejay Pharmaceuticals Limited Pethidine Injection Pethidine 40mg, per ml 5506 Injection POM Solution for 147/009 Tejay Pharmaceuticals Limited Quinine Injection Quinine 300mg, per ml 5507 Injection POM Eye Drops 147/010 Tejay Pharmaceuticals Limited Chloramphenicol Drops Chlorampehicol BP 0.5% 5508 5509 Betamethasone Drops Betamethasone 0.1% POM Eye Drops 147/011 Tejay Pharmaceuticals Limited

Page 283 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Neomycin + POM Eye Drops 147/012 Tejay Pharmaceuticals Limited Betamethasone Plus Drops 5510 Betamethasone 0.45% 5511 Ciprofloxacin Eye/Ear Drops Ciprofloxacin 0.3% POM Eye Drops 147/013 Tejay Pharmaceuticals Limited Analgin I.P 500mg, per POM Solution for 147/014 Tejay Pharmaceuticals Limited Analgin Injection 5512 ml Injection Neomycin Sulphate + POM Ear/Eye Drops 147/015 Tejay Pharmaceuticals Limited Dexamethasone+ Neoomycin Dexamethasone Eye/Ear Drops 5513 Phosphate Promethazine POM Solution for 147/016 Tejay Pharmaceuticals Limited Promethazine Injection Hydrochloride 25mg, per Injection 5514 ml Gentamycin Sulphate POM Ear/Eye Drops 147/018 Tejay Pharmaceuticals Limited Gentamycin Eye/Ear Drops 5515 0.3% Lignocaine POM Solution for 147/020 Tejay Pharmaceuticals Limited Lignocaine 2% Injection 5516 Dihydrochloride 2.0% Injection POM Solution for 147/021 Tejay Pharmaceuticals Limited Hydralazine Injection Hydralazine 20mg, per ml 5517 Injection Dexamethasone POM Solution for 147/022 Tejay Pharmaceuticals Limited Dexamethasone Injection 5518 Phosphate 0.1%w/v Injection POM Solution for 147/023 Tejay Pharmaceuticals Limited Diclofenac Sodium Injection Diclofenac Sodium 25mg 5519 Injection Metoclopromide POM Solution for 147/024 Tejay Pharmaceuticals Limited Metoclopromide Injection Hydrochloride USP 5mg, Injection 5520 per ml Hyocine Butylbromide POM Solution for 147/025 Tejay Pharmaceuticals Limited Hyoscine Butylbromide Injection 5521 20mg, per ml Injection Potassium Chloride POM Solution for 147/026 Tejay Pharmaceuticals Limited Potassium Chloride Injection 5522 Injection 150mg, per ml Injection POM Solution for 147/027 Tejay Pharmaceuticals Limited Calcium Gluconate Injection Calcium Gluconate 15mg 5523 Injection 5524 Pilocarpine Nitrate Eye Drops Pilocarpine Nitrate 15mg POM Eye Drops 147/028 Tejay Pharmaceuticals Limited Sodium Cromoglycate Eye Sodium Cromoglycate P Eye Drops 147/029 Tejay Pharmaceuticals Limited 5525 Drops 2% 5526 Xylomethazoline Nasal Drops Xylomethazoline 0.1% P Nasal drops 147/030 Tejay Pharmaceuticals Limited 5527 Timolol Eye Drops Timolol 0.5% POM Eye Drops 147/031 Tejay Pharmaceuticals Limited Sodium Bicarbonate POM Solution for 147/032 Tejay Pharmaceuticals Limited Sodium Bicarbonate Injection 5528 8.4% Injection POM Solution for 147/033 Tejay Pharmaceuticals Limited Magnesium Sulphate Injection Magnesium Sulphate 5529 Injection

Page 284 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 5530 Atropin Sulphate Eye Drops Atropin Sulphate 1% POM Eye Drops 147/034 Tejay Pharmaceuticals Limited POM Solution for 147/035 Tejay Pharmaceuticals Limited Morphine Sulphate Injection Morphine Sulphate 5531 Injection P Syrup 147/036 Tejay Pharmaceuticals Limited Adhatoda vasica 0.68gm + Piper longum 0.14gm + Vitis vinifera 0.14gm + Terminalia chebula 73.24mg + Woodfordia fruti- cosa 1.14gm + Asmarid Syrup Glycyrhiza glabra 6.78mg + Ficas infectoria 6.78mg + Acorns calamus 6.78mg + Trikatu ( Piper longum + Piper nigrum + Zingiber officinalis 5532 P Syrup 147/037 Tejay Pharmaceuticals Limited Chlopheniramine Maleate Histinil Syrup BP 2mg, per 5ml 5533 5534 Panridol Syrup P Syrup 147/038 Tejay Pharmaceuticals Limited Promethazine 5mg, per P Syrup 147/039 Tejay Pharmaceuticals Limited Promethazine Syrup 5535 5ml Paracetamol + P Syrup 147/040 Tejay Pharmaceuticals Limited Guaiphen Cough Syrup Chlopheniramine + 5536 Guaiphenesin Sulphamethoxazole + POM Suspension for 147/041 Tejay Pharmaceuticals Limited Co-Trimoxazole Suspension Trimethoprim 240mg, per Oral Use 5537 5ml 5538 Diclofenac Eye Drops Diclofenac 1.1% POM Eye Drops 147/042 Tejay Pharmaceuticals Limited Hydroxypropyl Methyl P Eye Drops 147/043 Tejay Pharmaceuticals Limited Arti Tear 5539 Cellulose Betamethasone 0.1% + POM Eye Drops 147/044 Tejay Pharmaceuticals Limited Betagenta Eye/Ear Drops 5540 Gentamycin 0.3% Betamethasone 0.1% + POM Ear/Eye Drops 147/045 Tejay Pharmaceuticals Limited Dexagenta Eye/Ear Drops 5541 Gentamycin 0.3% Dexamethasone 0.1%+ POM Ear/Eye Drops 147/046 Tejay Pharmaceuticals Limited Chlordex Eye/Ear Drops 5542 Chloramphenicol 0.5% 5543 Tvision Eye Drops Lignocaine 0.02% POM Eye Drops 147/047 Tejay Pharmaceuticals Limited

Page 285 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Phytomenadione 10mg, POM Solution for 147/048 Tejay Pharmaceuticals Limited Menadione Bisufite Injection 5544 per ml Injection Diphenylhydramine P Syrup 147/049 Tejay Pharmaceuticals Limited Hydrochloride 10mg + Histinil with Codiene Codeine Phosphate 10mg + Ammonium 5545 Chloride 125mg Terpentine + Eucalyptus P Cream Topical 003/004 The Mentholatum company Ltd, UK Mentholatum Deep Rub + Menthol + Methyl 5546 Salicylate Camphor + Menthol + GS Ointment topical 003/006 The Mentholatum company Ltd, UK Mentholatum Balm 5547 Methyl Salicylate Centbucridine + P Gel Topical 171/001 Themis Medicare Ltd, India Sepgard Gel 5548 Feracrylum 1% 5549 Simvastol 10mg Tablets Simvastatin 10mg POM Tablet Uncoated 171/002 Themis Medicare Ltd, India 5550 Simvastol 20mg Tablets Simvastatin 20mg POM Tablet Uncoated 171/003 Themis Medicare Ltd, India P Solution for Topical 171/004 Themis Medicare Ltd, India Hemolok Solution Feracrylum 1%w/v 5551 Use Artemether 150mg, per POM Solution for 171/005 Themis Medicare Ltd, India E Mal Injection 5552 2ml Injection Theoxone Plus 1500 Injection Ceftriaxone sodium POM Powder for 454/001 Theon Pharmaceuticals Limited 1000mg + Sulbactum Injection 5553 sodium 500mg GS Capsule oral 069/001 Tianjin Tianshi Biological Engineering Co. 7-Forces Capsules Herbal Extracts 115mg 5554 Ltd, China GS Capsule oral 069/002 Tianjin Tianshi Biological Engineering Co. Casper Capsules Herbal Extracts 5555 Ltd, China GS Capsule oral 069/003 Tianjin Tianshi Biological Engineering Co. Mega-Mind 1120mg Capsules Herbal Extracts 1120mg 5556 Ltd, China GS Capsule oral 069/004 Tianjin Tianshi Biological Engineering Co. Vega Power 710mg Capsules Herbal Extracts 710mg 5557 Ltd, China Ferrous Sulphate P Capsule oral 069/005 Tianjin Tianshi Biological Engineering Co. CZF-Iron 55.3mg Capsules 16.33mg + Zinc Sulfate Ltd, China 5558 15mg + Vitamin C 24mg P Capsule oral 069/006 Tianjin Tianshi Biological Engineering Co. Dia Gins Soft Gel Capsules Ginseng Extract 100mg 5559 Ltd, China Garlic Oil 0.66mg + GS Capsule oral 069/007 Tianjin Tianshi Biological Engineering Co. Toma Soft Gelatin Capsules 5560 Biloba Extract 120mg Ltd, China

Page 286 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Royal Jelly 600mg + GS Capsule oral 069/008 Tianjin Tianshi Biological Engineering Co. King Royal 600mg Capsules 5561 Puama Extract 30mg Ltd, China Royal Jelly 200mg + P Capsule oral 069/009 Tianjin Tianshi Biological Engineering Co. Damiana Extract 200mg Ltd, China Ever Youth Capsules + Evening Primrose 5562 Extract 250mg 5563 Antidep Tablets Imipramine 25mg POM Tablet Uncoated 089/061 Torrent Pharmaceuticals Limited, India Esomeprazole POM Tablet Enteric 089/062 Torrent Pharmaceuticals Limited, India Nexpro -40 Tablets Magnesium Trihydrate Coated 5564 40mg Esomeprazole POM Tablet Enteric 089/063 Torrent Pharmaceuticals Limited, India Nexpro -20 Tablets Magnesium Trihydrate Coated 5565 20mg 5566 Listril-10 Tablets Lisinopril 10mg POM Tablet Uncoated 082/022 Torrent Exports Limited, India 5567 Rantin-150 Tablets Ranitidine 150mg POM Tablet Uncoated 089/003 Torrent Exports Limited, India 5568 Quintor-500 Tablets Ciprofloxacin 500mg POM Tablet Film coated 089/007 Torrent Exports Limited, India 5569 Herpex-200 Tablets Acyclovir 200mg POM Tablet Uncoated 089/008 Torrent Exports Limited, India 5570 Herpex Cream Aciclovir 5%w/w POM Cream Topical 089/009 Torrent Exports Limited, India POM Tablet extended 089/010 Torrent Exports Limited, India Calcigard Retard Tablets Nifedipine 20mg 5571 release 5572 Tozaar - 50 Tablets Losartan 50mg POM Tablet Film coated 089/011 Torrent Exports Limited, India 5573 Domstal Tablets Domperidone 10mg POM Tablet Uncoated 089/012 Torrent Exports Limited, India Domperidone 1mg, per POM Suspension for 089/013 Torrent Exports Limited, India Domstal Suspension 5574 ml Oral Use POM Solution for 089/014 Torrent Exports Limited, India Ranitin Injection Ranitidine 25mg 5575 Injection 5576 Toroxx -MT-50 Tablets Rofecoxib 50mg POM Tablet Uncoated 089/016 Torrent Exports Limited, India Mannitol USP + POM Tablet Film coated 089/017 Torrent Exports Limited, India Deplatt Tablets 5577 Clopidogrel I.H 5578 Uroflox -400 Tablets Norfloxacin 400mg POM Tablet Uncoated 089/018 Torrent Exports Limited, India 5579 Betacard-100 Tablets Atenolol 100mg POM Tablet Uncoated 089/019 Torrent Exports Limited, India 5580 Syscan-100 Caspules Fluconazole 100mg POM Capsule oral 089/020 Torrent Exports Limited, India 5581 Omizac Capsules Omeprazole 20mg POM Capsule oral 089/021 Torrent Exports Limited, India 5582 Syscan- 200 Capsules Fluconazole 200mg POM Capsule oral 089/023 Torrent Exports Limited, India Tocofer-200 Soft Gelatin POM Capsule oral 089/024 Torrent Exports Limited, India Vitamin E 200mg 5583 Capsules 5584 Tocofer-400 Capsules Vitamin E 400mg POM Capsule oral 089/025 Torrent Exports Limited, India 5585 Batacard-50 Tablets Atenolol 50mg POM Tablet Uncoated 089/026 Torrent Exports Limited, India 5586 Syscan-150 Capsules Fluconazole 150mg POM Capsule oral 089/027 Torrent Exports Limited, India

Page 287 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 5587 Calcigard-10 Capsules Nifedipine 10mg POM Capsule oral 089/028 Torrent Exports Limited, India 5588 Lopamide Tablets Loperamide 2mg POM Tablet Uncoated 089/029 Torrent Exports Limited, India Metronidazole 5mg, per POM Solution for 089/030 Torrent Exports Limited, India Ive Metro Injection 5589 ml Infusion 5590 Tormoxine 250 Capsules Amoxicillin 250mg POM Capsule oral 089/031 Torrent Exports Limited, India 5591 Listril-5 Tablets Lisinopril 5mg POM Tablet Uncoated 089/032 Torrent Exports Limited, India 5592 Fegem 100 Tablets Ferric Hydroxide 450mg P Tablet Uncoated 089/033 Torrent Exports Limited, India 5593 Herpex 800 DT Tablets Acyclovir 800mg POM Tablet Uncoated 089/035 Torrent Exports Limited, India 5594 Modlip 10 Tablets Atorvastatin 10mg POM Tablet Film coated 089/036 Torrent Exports Limited, India Omeprazole 10mg + POM Capsule oral 089/037 Torrent Exports Limited, India Domstal O Capsules 5595 Domperidone 10mg 5596 Modlip 20 Tablets Atorvastatin 20mg POM Tablet Film coated 089/038 Torrent Exports Limited, India 5597 Lamitor 100 Tablets Lamotrigine 100mg POM Tablet Uncoated 089/039 Torrent Exports Limited, India 5598 Nebicard -5 Tablets Nebivolol 5mg POM Tablet Uncoated 089/040 Torrent Exports Limited, India 5599 Velos-20 Tablets Rabeprazole 20mg POM Tablet Uncoated 089/041 Torrent Exports Limited, India 5600 Velos-Tablets Rabeprazole 10mg POM Tablet Uncoated 089/042 Torrent Exports Limited, India POM Tablet Uncoated 089/043 Torrent Exports Limited, India Valparin 200 Tablets Sodium Valproate 200mg 5601 5602 Tide-10 Tablets Torasemide 10mg POM Tablet Uncoated 089/044 Torrent Exports Limited, India 5603 Lefra 20 Tablets Leflunomide 20mg POM Tablet Uncoated 089/045 Torrent Exports Limited, India 5604 Karvil-6.25 Tablets Carvedilol 6.25mg POM Tablet Uncoated 089/046 Torrent Exports Limited, India 5605 Esam-2.5 Tablets Amlodipine 2.5mg POM Tablet Uncoated 089/047 Torrent Exports Limited, India 5606 Azulix 2 Tablets Glimepiride 2mg POM Tablet Uncoated 089/048 Torrent Exports Limited, India 5607 Topril Capsules Ramipril 5mg POM Capsule oral 089/049 Torrent Exports Limited, India 5608 Serenata-50 Tablets Sertraline 50mg POM Tablet Uncoated 089/050 Torrent Exports Limited, India 5609 Valzaar 80 Tablets Valsartan 80mg POM Tablet Uncoated 089/051 Torrent Exports Limited, India 5610 Valzaar 160 Tablets Valsartan 160mg POM Tablet Uncoated 089/052 Torrent Exports Limited, India POM Tablet Uncoated 089/053 Torrent Exports Limited, India Hydrochlorothiazide Tozaar-H 62.5mg Tablets 12.5mg + Losartan 50mg 5611 5612 Tozaar-100mg Tablets Losartan 125mg POM Tablet Uncoated 089/054 Torrent Exports Limited, India POM Powder for 089/055 Torrent Exports Limited, India Nexpro IV Injection Esomeprazole 40mg 5613 Injection Hydrochlorothiazide POM Tablet Uncoated 089/056 Torrent Exports Limited, India Tozaar-Plus DS 125mg Tablets 5614 25mg + Losartan 100mg POM Powder for 089/057 Torrent Exports Limited, India Torocef - 1 Injection Ceftriaxone 1000mg 5615 Injection POM Solution for 089/058 Torrent Exports Limited, India Quintor Infusion Ciprofloxacin 200mg 5616 infusion

Page 288 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER POM Solution for 089/059 Torrent Exports Limited, India Syscan -100ml I.V Infusion Fluconazole 200mg 5617 infusion 5618 Funginoc Cream Ketoconazole 2%w/w POM Cream Topical 089/060 Torrent Exports Limited, India Montelukast Sodium IH POM Tablet Uncoated 089/064 Torrent Exports Limited, India Asthator 5 Tablets 5619 5mg Montelukast Sodium IH POM Tablet Uncoated 089/065 Torrent Exports Limited, India Asthator 10 Tablets 5620 10mg Montelukast Sodium BP POM Tablet Uncoated 089/066 Torrent Exports Limited, India Asthator 4 Tablets 5621 4mg Olmesartan Medoxomil POM Tablet Uncoated 089/068 Torrent Exports Limited, India Olmecor Tablets 5622 Hydrochloride 40mg POM Tablet Uncoated 089/069 Torrent Exports Limited, India Alfuzosine Hydrochloride Alfutor ER Tablets USP 10mg 5623 Boom Force Toilet Cleaner Cetyl Dimethyl GS Liquid Soap 430/004L Trade Kings Group Ltd, Zambia Ammonium Chloride 2.0 5624 %w/w Boom Force Multipurpose Liquid PCMX-Chloroxylenol GS Liquid Soap 430/006L Trade Kings Group Ltd, Zambia 5625 Detergent - Pine Fresh 1.0% w/w Romeo Hygienix Instant Hand Ethanol 60%w/w GS Liquid soap 430/012L Trade Kings Group Ltd, Zambia 5626 Sanitizer Gel Romeo+ Hygienix -Liquid Soap Silver Sulfate 0.3%w/w GS Liquid soap 430/014L Trade Kings Group Ltd, Zambia With Active Silver Sulphate and 5627 formulate Boom Force 'Multipurpose' Sodium Hypochloride 3.0 GS Liquid Soap 430/005L Trade Kings Group Ltd, Zambia 5628 Thick Bleach %w/w Boom Sparkle Plus Dishwash Chloroxylenol 0.01 %w/w GS Liquid detergent 430/008L Trade Kings Group Ltd, Zambia 5629 Liquid Orange Yebo Medicated Health Soap Para-Chloro-Meta- GS Solid Soap 430/009L Trade Kings Group Ltd, Zambia Xylenol 0.04635%w/v+Cresylic 5630 Acid 0.8552%w/ Xtra No.1 Soap PCMX/Cresylic Acid GS Soap 430/011L Trade Kings Group Ltd, Zambia 5631 98%w/w Romeo+ Hygienix Soap with Silver Sulfate 0.3%w/w GS Soap 430/013L Trade Kings Group Ltd, Zambia 5632 Active Silver Technology Boom Shine Plus Tile Cleaner Silver Sulfate 2.0% w/w GS Liquid Soap 430/007L Trade Kings Group Ltd, Zambia 5633 Lavender Blossom

Page 289 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Pure Plus Water Purification Sodium Hypochloride 0.5- GS Solution for Topical 430/010L Trade Kings Group Ltd, Zambia 5634 Solution 0.6% w/w Use Acetyl Salicylic Acid 300mg Acetycylsalicylic Acid BP GS Tablet Uncoated 110/002 Troge Medical GMBH, Germany 5635 Tablets 300mg 5636 Amoxicillin 250 Capsules Amoxicilin 250mg POM Capsule oral 110/003 Troge Medical GMBH, Germany 5637 Trio-Vital Tablets Multivitamin GS Tablet Uncoated 110/003 Troge Medical GMBH, Germany Amoxicilin 125mg, per POM Powder for Oral 110/004 Troge Medical GMBH, Germany Amoxicillin Suspension 5638 5ml Suspension 5639 Tetracycline 250mg Capsules Tetracycline 250mg POM Capsule oral 110/005 Troge Medical GMBH, Germany Tetracycline Ophthalmic Tetracycline POM Eye Ointment 110/006 Troge Medical GMBH, Germany 5640 Ointment Hydrochloride 1%w/v POM Powder for 110/008 Troge Medical GMBH, Germany Ampicillin Injection Ampicillin 500mg 5641 Injection POM Suspension for 110/009 Troge Medical GMBH, Germany Ampicillin Oral Suspension Ampicillin 125mg, per ml 5642 Oral Use POM Powder for 110/010 Troge Medical GMBH, Germany Streptomycin Injection Streptomycin Sulphate 1g 5643 Injection POM Solution for 110/011 Troge Medical GMBH, Germany Vitamin B Complex Injection Vitamin B Complex 5644 Injection Crystalline Benzylpenicillin POM Solution for 110/012 Troge Medical GMBH, Germany Benzyl Penicillin 1Mega 5645 Injection Injection 5646 Indomethacin 25mg Capsules Indomethacin 25mg POM Capsule oral 110/015 Troge Medical GMBH, Germany 5647 Metronidazole 200mg Tablets Metronidazole 200mg POM Tablet Uncoated 110/016 Troge Medical GMBH, Germany Phenoxymethyl Penicillin 250 Phenoxymethyl Penicillin POM Tablet Uncoated 110/018 Troge Medical GMBH, Germany 5648 Tablets 250mg Crystalline Benzyl Penicillin POM Solution for 110/019 Troge Medical GMBH, Germany Benzyl Penicillin 5mega 5649 Injection Injection 5650 Chloramphenicol Eye Ointment Chlorampenicol 1%w/w POM Eye Ointment 110/021 Troge Medical GMBH, Germany Fortified Procaine Penicillin POM Powder for 110/022 Troge Medical GMBH, Germany Procain Penicillin 4Mega 5651 Injection Injection Gentamycin 80mg, per POM Solution for 110/023 Troge Medical GMBH, Germany Gentamycin Injection 5652 2ml Injection 5653 Griseofulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 110/024 Troge Medical GMBH, Germany POM Powder for 110/025 Troge Medical GMBH, Germany Chlorampenicol Sodium Chloramphenicol Injection Injection Succinate Injection BP 1g 5654 Trimethoprim 80mg + POM Tablet Uncoated 110/026 Troge Medical GMBH, Germany Co-trimoxazole Tablets Sulphamethoxazole 5655 400mg

Page 290 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Ampicillin 250mg + POM Capsule oral 110/027 Troge Medical GMBH, Germany Ampicillin/Cloxacillin Capsules 5656 Cloxacillin 250mg Erythromycin Stearate POM Tablet Uncoated 110/029 Troge Medical GMBH, Germany Erythromycin Tablets 5657 BP 250mg POM Solution for 196/001 Troikaa Pharmaceuticals Limited, India Dynapar AQ 3ml Injection Diclofenac 25mg, per ml 5658 Injection Hydrocortisone Sodium POM Powder for 196/002 Troikaa Pharmaceuticals Limited, India Hydrocortisone 100mg 5659 Succinate Injection Injection Gentamicin 80mg, per POM Solution for 196/004 Troikaa Pharmaceuticals Limited, India Gentamicin Sulphate Injection 5660 2ml Injection Diclofenac 50mg + P Tablets Uncoated 196/005 Troikaa Pharmaceuticals Limited, India Dynapar tablets 5661 Paracetamol 500mg Ketamine Hydrochloride POM Solution for 196/006 Troikaa Pharmaceuticals Limited, India Ketamax-50 Injection 5662 50mg, per ml Injection 5663 Dynapar SR 100 Tablets Diclofenac 100mg POM Tablet Uncoated 196/007 Troikaa Pharmaceuticals Ltd, India POM Solution for 196/008 Troikaa Pharmaceuticals Ltd, India Dynapar AQ 1ml Injection Diclofenac 75mg 5664 Injection POM Solution for 196/009 Troikaa Pharmaceuticals Ltd, India Isotroy 100 Liquid Isoflurane 1mg, per ml 5665 Inhalation POM Powder for 196/010 Troikaa Pharmaceuticals Ltd, India Troypofol Injection Propofol 10mg, per ml 5666 Injection Atracurium Besylate POM Solution for 196/011 Troikaa Pharmaceuticals Ltd, India Troycurium Injection 5667 10mg/ml Injection GS Tablet extended 196/012 Troikaa Pharmaceuticals Ltd, India Xykaa Extend Tablets Paracetamol 650mg 5668 release Atorvastatin Calcium POM Tablet Uncoated 196/013 Troikaa Pharmaceuticals Ltd, India Lesstrol -10 Tablets 5669 10mg 5670 Telmikaa - 40 Tablets Telmisartan 40mg POM Tablet Uncoated 196/014 Troikaa Pharmaceuticals Ltd, India 5671 Telmikka - 80 Tablets Telmisartan 80mg POM Tablet Uncoated 196/015 Troikaa Pharmaceuticals Ltd, India 5672 Feno TG Tablets Fenofibrate 160mg POM Tablet Uncoated 196/016 Troikaa Pharmaceuticals Ltd, India Telmisartan 40mg + POM Tablet Uncoated 196/017 Troikaa Pharmaceuticals Ltd, India Telmikaa -H Tablets Hydrochlorothiazide 5673 12.50mg Losartan Potassium POM Tablet Uncoated 196/018 Troikaa Pharmaceuticals Ltd, India Zyltan 50 Tablets 5674 50mg 5675 Xykaa Rapid Tablets Paracetamol 500mg GS Tablet Uncoated 196/019 Troikaa Pharmaceuticals Ltd, India Bupivacaine POM Solution for 196/020 Troikaa Pharmaceuticals Ltd, India Bupitroy 0.5% Injection Hydrochloride 0.5mg Injection 5676 USP

Page 291 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Diclofenac Diethyl Amine P Solution for Topical 196/021 Troikaa Pharmaceuticals Ltd, India Dynapar QPS Topical Solution 5677 46.40mg Use Diclofenac Diethyl Amine P Solution for Topical 196/022 Troikaa Pharmaceuticals Ltd, India Dynapar QPS Plus Topical 23.20mg + Methyl Use Soution Salicylate 100.00mg + 5678 Menthol 50mg Diltiazem Hydrochloride POM 196/023 Diltigesic Gel Gel Topical Troikaa Pharmaceuticals Ltd, India 5679 2% w/w 5680 Ucetamol-500 Tablets Paracetamol 500mg GS Tablet Uncoated 193/001 Umedica Laboratories (Pvt Ltd, India 5681 Erythromycin 250mg Tablets Erythromycin 250mg POM Tablet Uncoated 193/002 Umedica Laboratories (Pvt Ltd, India 5682 Nifedipine Retard-20 Tablets Nifedipine 20mg POM Tablet Uncoated 193/003 Umedica Laboratories (Pvt Ltd, India POM Powder for 193/004 Umedica Laboratories (Pvt Ltd, India Ucetaxime-1000 Injection Cetaxime 1000mg 5683 Injection Sulphamethoxazole POM Tablet Uncoated 193/005 Umedica Laboratories (Pvt Ltd, India Co-Trimoxazole 480mg Tablets 400mg + Trimethoprim 5684 80mg 5685 Umoxil-250mg Capsules Amoxicillin 250mg POM Capsule Oral 193/006 Umedica Laboratories (Pvt Ltd, India POM Powder for 193/007 Umedica Laboratories (Pvt Ltd, India Benzyl Penicillin 5 M.U Injection Benzyl Penicillin 5M.U 5686 Injection Sulphamethoxazole POM Suspension for 193/008 Umedica Laboratories (Pvt Ltd, India Co-Trimoxazole 240mg/5ml 200mg + Trimethoprim Oral Use Oral Suspension 5687 80mg Umoxil-125mg/5ml Powder For Amoxicillin 125mg, per POM Powder for Oral 193/009 Umedica Laboratories (Pvt Ltd, India 5688 Oral Suspension 5ml Suspension Umeran 50 (Diclofenac 50mg P Tablet Oral 193/010 Umedica Laboratories (Pvt Ltd, India Diclofenac 50mg 5689 Tablets 5690 Kojex Tablets Liquorice 180mg GS Tablet Uncoated 193/013 Umedica Laboratories (Pvt Ltd, India P Solution for Oral 193/014 Umedica Laboratories (Pvt Ltd, India Umedica Blood Tonic Haematic Preparation 5691 Use 5692 Uroxime 250 Tablets Cefuroxime 250mg POM Tablet Uncoated 193/015 Umedica Laboratories (Pvt Ltd, India 5693 Uroxime 500 Tablets Cefuroxime 500mg POM Tablet Uncoated 193/016 Umedica Laboratories (Pvt Ltd, India Paracetamol 100mg + P Tablet Uncoated 193/017 Umedica Laboratories (Pvt Ltd, India Fast Releif Tablets 5694 Aceclofenac 500mg Sulfadoxine 500mg + P Tablet Uncoated 193/018 Umedica Laboratories (Pvt Ltd, India Malidar Tablets 5695 Pyrimethamine 25mg 5696 Fixdep -180 Tablets Fexofenadine 180mg POM Tablet Uncoated 193/019 Umedica Laboratories (Pvt Ltd, India 5697 Unimezol Tablets Metronidazole 200mg POM Tablet Uncoated 268/001 Unichem Laboratories Limited, India 5698 Zyncet Tablets Cetirizine 10mg POM Tablet Uncoated 268/002 Unichem Laboratories Limited, India 5699 Zyncet Syrup Cetirizine 5mg, per 5ml POM Syrup 268/003 Unichem Laboratories Limited, India

Page 292 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER 5700 Evaflox Tablets Ofloxacin 200mg POM Tablet Uncoated 268/004 Unichem Laboratories Limited, India 5701 Evaflox 400 Tablets Ofloxacin 400mg POM Tablet Uncoated 268/005 Unichem Laboratories Limited, India 5702 M-Cam 15 Tablets Meloxicam 15mg POM Tablet Uncoated 268/006 Unichem Laboratories Limited, India 5703 M-Cam 7.5 Tablets Meloxicam 7.5mg POM Tablet Uncoated 268/007 Unichem Laboratories Limited, India Atenolol 50mg + POM Tablet Uncoated 268/008 Unichem Laboratories Limited, India Corvadil-A Tablets 5704 Amlodipine 5mg 5705 Tagera Forte Tablets Secnidazole 1g POM Tablet Uncoated 268/009 Unichem Laboratories Limited, India Ampicillin 500mg + POM Powder for 268/010 Unichem Laboratories Limited, India Sulbacin Injection 5706 Sulbactam 250mg Injection Ampicillin 500mg + POM Tablet Uncoated 268/011 Unichem Laboratories Limited, India Sulbacin 375 Tablets 5707 Sulbactam 250mg 5708 Domadol Capsules Tramadol 50mg POM Capsule oral 268/012 Unichem Laboratories Limited, India POM Solution for 268/013 Unichem Laboratories Limited, India Domadol Injection Tramadol 50mg 5709 Injection 5710 Tg Tor Tablets Atorvastatin 10mg POM Tablet Uncoated 268/014 Unichem Laboratories Limited, India 5711 Corvadil 5 Tablets Amlodipine 5mg POM Tablet Uncoated 268/015 Unichem Laboratories Limited, India 5712 Losar-50 Tablets Losartan 50mg POM Tablet Uncoated 268/016 Unichem Laboratories Limited, India Amoxicillin 500mg + POM Tablet Uncoated 268/018 Unichem Laboratories Limited, India Myclav 625 Tablets 5713 Clavulanate 125mg POM Solution for 268/019 Unichem Laboratories Limited, India Domadol 100mg Injection Tramadol 100mg 5714 Injection Fungal Distate (1:8000) P Tablet Chewable 268/020 Unichem Laboratories Limited, India 20mg + Papain 30mg + Unienzyme Cmps Tablet Simethicone 30mg + Act 5715 75mg Bisoprolol Fumerate POM Tablet Uncoated 268/021 Unichem Laboratories Limited, India Corbis - 10 Tablets 5716 10mg POM Tablet Uncoated 268/022 Unichem Laboratories Limited, India Corbis-5 Tablets Bisoprolol Fumerate 5mg 5717 5718 Aroff Tablets Aceclofenac 100mg P Tablet Film coated 268/023 Unichem Laboratories Limited, India Amoxicillin Trihydrate POM Suspension 268/024 Unichem Laboratories Limited, India Myclav Powder 228.5 200mg + Potassium Suspension 5719 Clavulanate 28.5mg Amoxicillin Trihydrate POM Suspension 268/025 Unichem Laboratories Limited, India Myclav Powder 156.25 125mg + Potassium Suspension 5720 Clavulanate 28.5mg Amoxicillin 250mg + POM Tablet Uncoated 286/017 Unichem Laboratories Limited, India Myclav 375 Tablets 5721 Clavulanate 125mg

Page 293 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Acetaminophen 325mg + POM Tablet Film coated 288/026 Unichem Laboratories Limited, India Domadol Plus Tablets Tramadol Hydrocholoride 5722 37.5mg 5723 Quetia 25 Tablets Quentiapine 25mg POM Tablet Uncoated 288/027 Unichem Laboratories Limited, India 5724 Quetia 100 Tablets Quentiapine 100mg POM Tablet Uncoated 288/028 Unichem Laboratories Limited, India 5725 Quetia 200 Tablets Quentiapine 200mg POM Tablet Uncoated 288/029 Unichem Laboratories Limited, India 5726 Quetia 300 Tablets Quentiapine 300mg POM Tablet Uncoated 288/030 Unichem Laboratories Limited, India 5727 Lenor 72 Tablets Levonorgestrel 0.75mg POM Tablet Uncoated 223/001 Unicure Remedies (Pvt) Limited, India 5728 Mepen 250 Tablets Mefenamic Acid 250mg P Tablet Uncoated 223/002 Unicure Remedies (Pvt) Limited, India 5729 NC Norm-P Tablets Norethisterone 5mg POM Tablet Uncoated 223/003 Unicure Remedies (Pvt) Limited, India 5730 Eros 10 Tablets Tadalafil 10mg POM Tablet Uncoated 223/004 Unicure Remedies (Pvt) Limited, India 5731 Lactone 25 Tablets Spironolactone 25mg POM Tablet Uncoated 223/005 Unicure Remedies (Pvt) Limited, India 5732 Flagon 50 Tablets Diclofenac 50mg P Tablet Uncoated 223/006 Unicure Remedies (Pvt) Limited, India 5733 Blue Diamond Tablets Sildenafil 50mg POM Tablet Uncoated 223/007 Unicure Remedies (Pvt) Limited, India POM Tablet Film coated 223/008 Unicure Remedies (Pvt) Limited, India Ethinylestradiol 0.03mg + Florina -28 Tablets Levonorgestrel 0.15mg 5734 5735 Eros 20 Tablets Tadalafil 20mg POM Tablet Uncoated 223/010 Unicure Remedies (Pvt) Limited, India Dapoxetine POM Tablet Uncoated 223/011 Unicure Remedies (Pvt) Limited, India Goldman Tablets 5736 Hydrochloride 60mg Anhydrous Glucose + P Powder for Oral 223/07 Unicure Remedies (Pvt) Limited, India Vital-Z Powder Sucrose + Ascorbic Acid Solution 5737 + Zinc 5738 Love condoms Male Latex Condoms GS Latex Products 410/001L Unidus Corporation EHDP/ADPA/Etidronic GS Solid Soap 012/001 Unilever SEA Zambia Limited, Zambia Acid 0.04% + Lifebuoy Deofresh Bar Soap Tetrasodium EDTA 5739 0.02% EHDP + ADPA + GS Solid Soap 012/002 Unilever SEA Zambia Limited, Zambia Lifebuoy Total Red Bar Soap Etidronic Acid + 5740 Tetrasodium EDTA Geisha Germigaurd Soap Extrapone 5 Plant GS Solid Soap 012/002HM Unilever SEA Zambia Limited, Zambia 5741 (Neem & Soothing Basil) 0.0003%w/w EHDP/ADPA/Etidronic GS Solid Soap 012/003 Unilever SEA Zambia Limited, Zambia Acid 0.04% + Lifebuoy Herbal Bar Soap Tetrasodium EDTA 5742 0.02% Geisha Germigaurd Soap (Mint Extrapone 5 Plant GS Solid Soap 012/003HM Unilever SEA Zambia Limited, Zambia 5743 & Green Tea) 0.0003%w/w

Page 294 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER EHDP/ADPA/Etidronic GS Solid Soap 012/004 Unilever SEA Zambia Limited, Zambia Acid 0.04% + Lifebuoy Care Bar Soap Tetrasodium EDTA 5744 0.02% Trichlorocarbanilide GS Liquid soap 012/004L Unilever SEA Zambia Limited, Zambia 0.02% + DTPA-Na Lifebouy Antibacterial 0.125% + Glyceryl Mono Handwash - Care Laurate 0.05% + Tur 5745 0.05% Trichlorocarbanilide GS Liquid soap 012/005L Unilever SEA Zambia Limited, Zambia 0.02% + DTPA -Na Lifebouy Antibacterial 0.125% + Glyceryl Mono Handwash - Classic Laurate 0.05% + Tur 5746 0.05% Trichlorocarbanilide GS Liquid soap 012/006L Unilever SEA Zambia Limited, Zambia 0.02% + DTPA -Na Lifebouy Antibacterial 0.125% + Glyceryl Mono Handwash - Fresh Laurate 0.05% + Tur 5747 0.05% Trichlorocarbanilide GS Liquid soap 012/007L Unilever SEA Zambia Limited, Zambia 0.02% + DTPA -Na Lifebouy Antibacterial 0.125% + Glyceryl Mono Handwash-Nature Laurate 0.05% + Tur 5748 0.05% Trichlorocarbanilide GS Solid soap 012/001HM Uniliver SEA Zambia Limited, Zambia Lifebouy Herbal Antibacterial 0.04% + Trichlorosan Soap 5749 0.02% POM Powder for 356/001 Unimark Ramedies Limited, India IC2 500 Injection Imipenem 500mg 5750 Injection Meropenem Trihydrate POM Powder for 356/002 Unimark Ramedies Limited, India Vencer 250 Injection 5751 250mg Injection Meropenem Trihydrate POM Powder for 356/003 Unimark Ramedies Limited, India Vencer 1000 Injection 5752 1000mg Injection GS Capsule oral 072/011 Unique Pharmaceyticals Laboratories, India Pedvite Forte Capsules Multivitamins 5753 Epirubicin Hcl 50mg, per POM Powder for 314/001MT United Biotec (P) Ltd, India Epirubitec 50 Injection 5754 50ml Injection Oxaliplatin 100mg, per POM Solution for 314/002MT United Biotec (P) Ltd, India Oplatin 100 Injection 5755 50ml Injection

Page 295 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER POM Solution for 314/003MT United Biotec (P) Ltd, India Oncosid 100 Injection Etopside 100mg, per 5ml 5756 Injection Vinblastine Sulphate POM Solution for 314/004MT United Biotec (P) Ltd, India Uniblastin Injection 5757 10mg, per 10ml Injection POM Solution for 314/005MT United Biotec (P) Ltd, India Uniplatin 50 Injection Cisplatin 50mg, per 50ml 5758 Injection Leucovorin Calcium POM Tablet Uncoated 314/006MT United Biotec (P) Ltd, India Unifolin 15 Tablets 5759 15mg 5760 Citabin 500 Tablets Capacetabine 500mg POM Tablet Film coated 314/007MT United Biotec (P) Ltd, India Ondasetron POM Solution for 314/008MT United Biotec (P) Ltd, India O-SET - 4mg Injection 5761 Hydrochloride USP 4mg Injection Ondasetron POM Solution for 314/009MT United Biotec (P) Ltd, India O-SET - 8mg Injection 5762 Hydrochloride USP 8mg Injection POM Powder for 314/010MT United Biotec (P) Ltd, India UNICARB 150 Injection Dacarbazine 150mg USP 5763 Injection Darcabazine 150mg, per POM Solution for 314/011MT United Biotec (P) Ltd, India DACMED 150 Injection 5764 15ml Injection Clotrimazole 1%w/w + POM Cream Topical 283/001 Universal Corporation Ltd, Kenya Clotrine B Cream Betamethasone 5765 0.05%w/w 5766 Univir Cream Acyclovir 5%w/v POM Cream Topical 283/002 Universal Corporation Ltd, Kenya 5767 Univir 400 Tablets Aciclovir 400mg POM Tablet Uncoated 283/003 Universal Corporation Ltd, Kenya 5768 Strox Tablets Ciprofloxacin 500mg POM Tablet Uncoated 283/004 Universal Corporation Ltd, Kenya Sodium Chloride 3.5g + P Powder for Oral 283/005 Universal Corporation Ltd, Kenya Sodium Citrate 1.5g + Solution Unilyte Oral Powder Potassium Chloride 2.5g 5769 + Glucose 20g POM Suspension for 283/007 Universal Corporation Ltd, Kenya Nelzole Suspension Metronidazole 200mg 5770 Oral Use Sodium Bicarbonate GS Solution for Oral 283/008 Universal Corporation Ltd, Kenya Universal Gripe Water 50mg + Dill Oil 2.15mg, Use 5771 per 5ml Sulphamethoxazole POM Suspension for 283/009 Universal Corporation Ltd, Kenya Sulfran Paediatric Suspension 200mg + Trimethoprim Oral Use 5772 40mg, per 5ml Benzoic Acid 80mg + P Ointment topical 283/010 Universal Corporation Ltd, Kenya Unified Ointment 5773 Salicylic Acid 30mg 5774 Dinac Tablets Diclofenac 50mg P Tablet Uncoated 283/011 Universal Corporation Ltd, Kenya

Page 296 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Sulphamethoxazole POM Tablet Uncoated 283/012 Universal Corporation Ltd, Kenya Sulfran Tablets 400mg + Trimethoprim 5775 80mg 5776 Ulzol Capsules Omeprazole 20mg POM Capsule oral 283/013 Universal Corporation Ltd, Kenya 5777 Acnesol Cream Tretinoin 0.05%w/v P Cream Topical 283/014 Universal Corporation Ltd, Kenya 5778 Dinac Gel Diclofenac 1%w/v P Gel Topical 283/015 Universal Corporation Ltd, Kenya 5779 Clobit Cream Clobetasol 0.05%w/v P Cream Topical 283/016 Universal Corporation Ltd, Kenya 5780 Clotrine Pessaries Clotrimazole 100mg P Tablet Vaginal 283/017 Universal Corporation Ltd, Kenya 5781 Clotrine Cream Clotrimazole 1%w/v P Cream Topical 283/018 Universal Corporation Ltd, Kenya 5782 Flutrox Capsules Fluconazole 200mg POM Capsule oral 283/019 Universal Corporation Ltd, Kenya 5783 Lockit Tablets Domperidone 10mg POM Tablet Uncoated 283/020 Universal Corporation Ltd, Kenya P Solution for Oral 283/021 Universal Corporation Ltd, Kenya Nelstat Oral Drops Nystatin 100000IU 5784 Use Albendazole 400mg, per P Suspension for 283/022 Universal Corporation Ltd, Kenya Unibazole Suspension 5785 100ml Oral Use 5786 Unibazole Tablets Albendazole 400mg P Tablet Uncoated 283/023 Universal Corporation Ltd, Kenya 5787 Unibet Cream Betamethasone 0.1%w/v P Cream Topical 283/024 Universal Corporation Ltd, Kenya 5788 Univir 200 Tablets Aciclovir 200mg POM Tablet Uncoated 283/025 Universal Corporation Ltd, Kenya Paracetamol 500mg + GS Caplets oral 283/026 Universal Corporation Ltd, Kenya Neladol Extra Caplets 5789 Caffeine 65mg Uncoated Artemether 120mg + P Tablet Uncoated 283/027 Universal Corporation Ltd, Kenya Co-Max Tablets 5790 Lumefantrine 20mg Aluminium Hydrochloride P Tablet Uncoated 283/029 Universal Corporation Ltd, Kenya Actcid Tablets 120mg + Magnesium 5791 Trisilicate 250mg 5792 Unigentyl Tablets Secnidazole 500mg POM Tablet Uncoated 283/030 Universal Corporation Ltd, Kenya GS Solution for Oral 283/031 Universal Corporation Ltd, Kenya Rexedine Mouthwash Povidone Iodine 1% 5793 Use 5794 K-Nac 50 Tablets Diclofenac 50mg P Tablet Film coated 283/032 Universal Corporation Ltd, Kenya POM Caplets oral 283/033 Universal Corporation Ltd, Kenya Sulfamethoxazole 800mg Sulfran DS Caplets Uncoated + Trimethoprim 160mg 5795 5796 Erythro 250 Tablets Erythromycin 250mg POM Tablet Uncoated 283/034 Universal Corporation Ltd, Kenya Paracetamol 120mg, per GS Suspension for 283/035 Universal Corporation Ltd, Kenya Neladol Suspension 5797 5ml Oral Use 5798 Lolip 20mg Tablets Atorvastatin 20mg POM Tablet Uncoated 283/036 Universal Corporation Ltd, Kenya 5799 Lolip 10mg Tablets Atorvastatin 10mg POM Tablet Uncoated 283/037 Universal Corporation Ltd, Kenya 5800 K-Nac 75 Tablets Diclofenac 75mg P Tablet Uncoated 283/038 Universal Corporation Ltd, Kenya

Page 297 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Aminosidine 125mg, per POM Syrup 283/039 Universal Corporation Ltd, Kenya Unibrol Oral Syrup 5801 5ml 5802 Unibrol Tablets Aminosidine 250mg POM Tablet Uncoated 283/040 Universal Corporation Ltd, Kenya 5803 Altrine Syrup Cetirizine 5mg, per 5ml P Syrup 283/041 Universal Corporation Ltd, Kenya 5804 Altrine Tablets Cetirizine 10mg P Tablet Uncoated 283/042 Universal Corporation Ltd, Kenya 5805 Throza 500 tablets Azithromycin 500mg POM Tablet Uncoated 283/043 Universal Corporation Ltd, Kenya 5806 Zeenk 20 tablets Zinc sulphate 20mg General Sale Tablet Dispersible 283/044 Universal Corporation Ltd, Kenya Oral Rehydration Salts General Sale Powder for Oral 283/045 Universal Corporation Ltd, Kenya Zeerol Co-Pack for Diarrhoea Int. Ph 20.56g + Zinc Solution Treatment 5807 sulphate USP 20 5808 HB Glow Capsules Haematic Preparation P Capsule oral 054/001 Universal Pharmaceuticals Ltd, India P Solution for Oral 054/002 Universal Pharmaceuticals Ltd, India HB Glow Liquid Haematic Preparation 5809 Use P Solution for Oral 054/003 Universal Pharmaceuticals Ltd, India Unimin Liquid Minerals + Multivitamins 5810 Use 5811 Unimin Capsules Minerals + Multivitamins P Capsule oral 054/004 Universal Pharmaceuticals Ltd, India POM Solution for Oral 054/005 Universal Pharmaceuticals Ltd, India Mestil Liquid Salbutamol 1mg/5ml 5812 Use Ambroxol 15mg + P Solution for Oral 054/006 Universal Pharmaceuticals Ltd, India Mestil-S Liquid Salbutamol 1mg + Use 5813 Guaiphenesin 50mg P Solution for Oral 054/007 Universal Pharmaceuticals Ltd, India Unimin G Liquid Minerals + Multivitamins 5814 Use Ambroxol 30mg + P Solution for Oral 054/008 Universal Pharmaceuticals Ltd, India Mucorol-S Liquid Salbutamol 1mg + Use 5815 Guiaphenesin 50mg Cyproheptadine 2mg, per P Solution for Oral 054/009 Universal Pharmaceuticals Ltd, India Apitup-P Liquid 5816 5ml Use Ferrous Fumarate + P Capsule oral 054/010 Universal Pharmaceuticals Ltd, India Fradex Capsules 5817 Multivitamins + Minerals 5818 Softvit-E Capsules Vitamin E 200mg POM Capsule oral 054/011 Universal Pharmaceuticals Ltd, India 5819 Softvit-E Capsules Vitamin E 400mg POM Capsule oral 054/012 Universal Pharmaceuticals Ltd, India Probiotic (Streptococcus POM Capsule oral 054/013 Universal Pharmaceuticals Ltd, India Faecalis + Clostridium Butyricum + Bacillus Trilac Capsules Mesentericus + Lactic Acid Bacillus (Lactobacillus 5820 Sporogenes))

Page 298 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Probiotic (Streptococcus POM Granules for Oral 054/014 Universal Pharmaceuticals Ltd, India Faecalis + Clostridium Use Butyricum + Bacillus Trilac Sachets Mesentericus + Lactic Acid Bacillus(Lactobacillus 5821 Sporogenes)) POM Solution for 374/001 Unosource Pharma Ltd. India Vovenil Injection Diclofenac Sodium 25mg 5822 Injection Elemental Iron 20mg, per POM Solution for 374/002 Unosource Pharma Ltd. India Akurose Injection 5823 2ml Injection 5824 Corfex 250 Capsules Cephalexin 250mg POM Capsule 374/003 Unosource Pharma Ltd. India 5825 Corfex 500 Capsules Cephalexin 500mg POM Capsule 374/004 Unosource Pharma Ltd. India Progesterone 100mg, per POM Solution for 374/005 Unosource Pharma Ltd. India Prostar 100 Injection 5826 2ml Injection Progesterone 200mg, per POM Solution for 374/006 Unosource Pharma Ltd. India Prostar 200 Injection 5827 2ml Injection POM Solution for 374/007 Unosource Pharma Ltd. India Thermodol Infusion Paracetamol 1%w/v 5828 infusion Tranexamic Acid 100mg POM Solution for 374/008 Unosource Pharma Ltd. India Unotation Injection 5829 BP Injection POM Solution for 374/009 Unosource Pharma Ltd. India Welquine Infusion Levofloxacin 0.5%w/v 5830 infusion POM Powder for injection 374/010 Unosource Pharma Ltd. India Akumero 1000 Injection Meropenem 1000mg 5831 Ceftriaxone Sodium POM Solution for 374/011 Unosource Pharma Ltd. India Ceftrisone 1000 Injection 5832 1000mg Injection Clindamycin Phosphate POM Vaginal Suppostory 374/012 Unosource Pharma Ltd. India Damphos Vaginal Suppositories 100mg USP + 5833 Clotrimazole 100mg Tramadol Hydrochloride POM Solution for 374/013 Unosource Pharma Ltd. India Tradmin Injection 5834 50mg Injection Sodium bicarbonate - GS 374/014 Sarjikshara (Suddha) 2.6g + Citrus Medica Powder for Oral Tumbeno Unosource Pharma Ltd. India (Citric Acid) – Nimbu Solution Satva (Nimbukamlam) 5835 1.90g

Page 299 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER POM Solution for 374/015 Oflotech Infusion Ofloxacin USP 200mg Unosource Pharma Ltd. India 5836 Infusion KOFCLEAN Syrup - Herbal Adosa + Jesthimadh + P Syrup 374/017 Unosource Pharma Ltd. India 5837 Cough Syrup Pappli + Draksha + Tulsi Ceftrisone-S Ceftriaxone USP POM Solution for 374/018 Unosource Pharma Ltd. India 1000mg + Sulbactum Injection 5838 sodium USP 500mg Ultimate Condoms Banana Latex Condom GS Protective barrier 438/001L USAID Discover-Health Project 5839 Scented Ultimate Condoms Vanilla Latex Condom GS Protective barrier 438/002L USAID Discover-Health Project 5840 Scented 5841 Ultimate Condoms Smooth Latex Condoms GS Protective barrier 438/003L USAID Discover-Health Project 5842 Glynase XL-5 Tablets Glipizide 5mg POM Tablet Uncoated 282/001 USV Ltd, India 5843 Grovit Drops Multivitamin P Syrup 282/002 USV Ltd, India Pioglitazone POM Tablet Uncoated 282/003 USV Ltd, India Pioz-15 Tablets 5844 Hydrochloride 15mg Acetylsalicyclic Acid POM Tablet Uncoated 282/004 USV Ltd, India Ecorin-75 Tablets 5845 75mg 5846 Lipicard Capsules Fenofibrate 200mg POM Capsule oral 282/005 USV Ltd, India Amoxicillin 125mg, per POM Suspension for 230/002 Varichem Pharmaceuticals (Pvt) Ltd, Amoxen Suspension 5847 5ml Oral Use Zimbabwe POM Capsule oral 230/003 Varichem Pharmaceuticals (Pvt) Ltd, Amoxen Capsule Amoxicillin 250mg 5848 Zimbabwe Sulphamethoxazole POM Tablet Uncoated 230/004 Varichem Pharmaceuticals (Pvt) Ltd, Cotrizole Tablets 400mg + Trimethoprim Zimbabwe 5849 80mg POM Capsule oral 230/005 Varichem Pharmaceuticals (Pvt) Ltd, Cloxacillin Capsules Cloxacillin 250mg 5850 Zimbabwe GS Tablet Uncoated 230/006 Varichem Pharmaceuticals (Pvt) Ltd, Varipan Tablets Paracetamol 500mg 5851 Zimbabwe Lamivudine 150mg + POM Tablet Film coated 230/007 Varichem Pharmaceuticals (Pvt) Ltd, Varivar Tablets 5852 Zidovudine 300mg Zimbabwe Stavudine 30mg + POM Tablet Uncoated 230/008 Varichem Pharmaceuticals (Pvt) Ltd, STALANEV 30 Tablets Lamivudine 150mg + Zimbabwe 5853 Nevirapine 200mg

Page 300 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Glucose Anhydrous Ph. P Powder for Oral 230/009 Varichem Pharmaceuticals (Pvt) Ltd, Int 13.5g,+Glucose Solution Zimbabwe 75.0mmol/L + Sodium Chloride Ph.Int 2.6g + Sodium 75.0mmol/ L + Hydrasalts Oral Rehydration Trisodium Citrate Salts Dihydrate Ph.Int 2.9g+ Citrate 10.0mmol/L + Potassium Chloride Ph.Int 1.5g + Potassium 20.0mmol/L + Chloride 5854 65.0mmol/L Miconazole Nitrate 20mg POM Cream Topical 230/010 Varichem Pharmaceuticals (Pvt) Ltd, Micort Cream + Hydrocortisone Acetate Zimbabwe 5855 10mg Aluminium Hydrochloride GS Tablet Uncoated 230/011 Varichem Pharmaceuticals (Pvt) Ltd, Neutracid Tablets 120mg + Magnesium Zimbabwe 5856 Trisilicate 250mg GS Suspension for 230/012 Varichem Pharmaceuticals (Pvt) Ltd, Ibuprofen Oral Suspension Ibuprofen 100mg 5857 Oral Use Zimbabwe Erythromycin Stearate POM Tablet Uncoated 214/001 Venkant Pharma Limited, India Erythromycin Tablets 5858 250mg 5859 Cephalexin Capsules Cephalexin 500mg POM Capsule oral 214/002 Venkant Pharma Limited, India 5860 Ibuprofen Tablets Ibuprofen 400mg P Tablet Film coated 214/003 Venkant Pharma Limited, India 5861 Diclofenac Tablets Diclofenac 50mg P Tablet Uncoated 214/004 Venkant Pharma Limited, India 5862 Amoxicillin Capsules Amoxicillin 250mg POM Capsule oral 214/005 Venkant Pharma Limited, India 5863 Omeprazole Capsules Omeprazole 20mg POM Capsule oral 214/006 Venkant Pharma Limited, India 5864 Indomethacin Capsules Indomethacin 25mg P Capsule oral 214/007 Venkant Pharma Limited, India 5865 Ampicillin Capsules Ampicillin 250mg POM Capsule oral 214/008 Venkant Pharma Limited, India Ronem 500 Injection Meropenem Trihydrate POM Powder for 448/001 VENUS REMEDIES LTD 5866 500mg Injection Ronem 1000 Injection Meropenem Trihydrate POM Powder for 448/002 VENUS REMEDIES LTD 5867 1000mg Injection Methotrexate 50mg, per POM Powder for 084/001 VHB Medi Sciences Mtx-vhb Injection 5868 ml Injection Cefoperazone USP 0.5g POM Powder for 084/002 VHB Medi Sciences T- Bactum Injection 5869 + Sulbactam 0.5g Injection Ceftriazone USP 1g + POM Powder for 084/003 VHB Medi Sciences Zonactam Injection 5870 Tazobactam 125mg Injection

Page 301 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Cefepime Hydrochloride POM Powder for 084/004 VHB Medi Sciences Ce - Fine 1g Injection 5871 1g Injection Doxorubicin POM Solution for 084/005 VHB Medi Sciences Domaxin Rd 10mg Injection 5872 Hydrochloride 10mg Injection POM Powder for 084/006 VHB Medi Sciences Piperacillin Sodium 4g + Peractam 4.5 G Injection Injection Tazobactam Sodium 0.5g 5873 POM Capsule oral 160/001 Vigor Laboratories 586-A Mody Estates, Tetra 250 Capsules Tetracycline 250mg 5874 India P Cream Topical 160/002 Vigor Laboratories 586-A Mody Estates, Vardhmans Silver Cream Silver Sulfadiazine 1% 5875 India POM Cream Topical 160/003 Vigor Laboratories 586-A Mody Estates, Beclomethasone + Vardex Cream India Gentamycin + Econazole 5876 POM Cream Topical 160/004 Vigor Laboratories 586-A Mody Estates, Betavard Cream Betamethasone 1% 5877 India POM Ointment topical 160/005 Vigor Laboratories 586-A Mody Estates, Tetraskin Ointment Tetracycline 1% 5878 India Camphor + Eucalyptus GS Cream Topical 160/006 Vigor Laboratories 586-A Mody Estates, Oil + Turpentine Oil + India Vardman Strong Cream Methol + Methyl 5879 Salicylate Phenoxymethyl Penicillin POM Suspension for 160/007 Vigor Laboratories 586-A Mody Estates, Pen-V Oral Solution Suspension 5880 V 125mg, per 5ml Oral Use India POM Tablet Uncoated 160/008 Vigor Laboratories 586-A Mody Estates, Blimketas Tablets Levamisole 40mg 5881 India GS Tablet Uncoated 160/009 Vigor Laboratories 586-A Mody Estates, Conjex Tablets Liquorice 5882 India Sulphamethoxazole POM Tablet Uncoated 160/010 Vigor Laboratories 586-A Mody Estates, Cotrim 480 Tablets 400mg + Trimethoprim India 5883 80mg POM Tablet Uncoated 160/011 Vigor Laboratories 586-A Mody Estates, Doloprin Tablets Aspirin 5884 India GS Tablet Uncoated 160/012 Vigor Laboratories 586-A Mody Estates, Go-Cough Tablets Liquorice 189.98mg 5885 India P Capsule oral 160/013 Vigor Laboratories 586-A Mody Estates, Indo-25 Caspules Indomethacin 25mg 5886 India

Page 302 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Chlorpheniramine 2mg + P Tablet Uncoated 160/014 Vigor Laboratories 586-A Mody Estates, Jeri Stop Cold Tablets Caffeine 30mg + India 5887 Paracetamol 500mg P Tablet Uncoated 160/015 Vigor Laboratories 586-A Mody Estates, Mebenda-100 Tablets Mebendazole 100mg 5888 India Sulfadoxine + P Tablet Uncoated 160/016 Vigor Laboratories 586-A Mody Estates, Mekalfin Tablets 5889 Pyrimethamine 525mg India POM Tablet Uncoated 160/017 Vigor Laboratories 586-A Mody Estates, Metro-200 Tablets Metronidazole 200mg 5890 India Magnesium Trisilicate P Tablet Uncoated 160/018 Vigor Laboratories 586-A Mody Estates, MCT Tablets 5891 200mg India Pseudoephedrine + P Capsule oral 160/019 Vigor Laboratories 586-A Mody Estates, Parapain Capsules Chlorpheniramine + India 5892 Paracetamol 550mg POM Tablet Uncoated 160/020 Vigor Laboratories 586-A Mody Estates, Salbuta 2 Tablets Salbutamol 2mg 5893 India Cloxacillin Sodium POM Capsule oral 160/021 Vigor Laboratories 586-A Mody Estates, Symaclox 500 Capsules 5894 500mg India POM Tablet Uncoated 160/022 Vigor Laboratories 586-A Mody Estates, Analgin Tablets Dipyrone 500mg 5895 India Pyrantel Pamoate P Suspension for 160/023 Vigor Laboratories 586-A Mody Estates, Pyramoate Suspension 5896 125mg, per ml Oral Use India POM Cream Topical 160/024 Vigor Laboratories 586-A Mody Estates, Jonacan Cream Clotrimazole 1%w/v 5897 India P Tablets 160/025 Vigor Laboratories 586-A Mody Estates, Pyrantrin Tablets Pyrantel Pamoate 125mg 5898 India P Tablet Uncoated 160/027 Vigor Laboratories 586-A Mody Estates, Ibu-200 Tablets Ibuprofen 200mg 5899 India Loperamide POM Capsule oral 160/028 Vigor Laboratories 586-A Mody Estates, Lopamide Capsules 5900 Hydrochloride2mg India POM Tablet Vaginal 160/029 Vigor Laboratories 586-A Mody Estates, Nystatin Vaginal Tablets Nystatin 100,000I.U. 5901 India Magnesium Carbonate + GS Tablet Uncoated 160/030 Vigor Laboratories 586-A Mody Estates, Stamache Tablets 5902 Magnesium Hydroxide India POM Cream Topical 160/031 Vigor Laboratories 586-A Mody Estates, Kezoral Cream Ketoconazole 2% 5903 India POM Cream Topical 160/032 Vigor Laboratories 586-A Mody Estates, Vardacort Cream Hydrocortisone 1%w/w 5904 India

Page 303 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER POM Ointment topical 160/033 Vigor Laboratories 586-A Mody Estates, Vardacort Ointment Hydrocortisone 1%w/w 5905 India Metformin Hydrochloride POM Tablet Uncoated 160/034 Vigor Laboratories 586-A Mody Estates, Vardamin Tablets 5906 500mg India P Tablet Uncoated 160/035 Vigor Laboratories 586-A Mody Estates, Vardaplex Super Tablets B Complex 5907 India P Tablet Uncoated 160/036 Vigor Laboratories 586-A Mody Estates, Vardaplex Forte Tablets B Complex 5908 India P Gel Topical 160/037 Vigor Laboratories 586-A Mody Estates, Diclofenac Gel Diclofenac 1%w/w 5909 India POM Tablet Uncoated 160/038 Vigor Laboratories 586-A Mody Estates, Isoniazid Tablets Isoniazid 300mg 5910 India P Solution for Oral 160/039 Vigor Laboratories 586-A Mody Estates, Vard Blood Tonic Haematic Preparation 5911 Use India GS Lozenges 160/040 Vigor Laboratories 586-A Mody Estates, Kofsil Lozenges Eucalyptus + Menthol 5912 India Chlorpheniramine USP P Syrup 160/041 Vigor Laboratories 586-A Mody Estates, 2mg + Ammonium India Chloride BP 100mg + Guaifenesin BP 80mg + Safiphen Syrup Sodium Citrate BP 44mg + Terpine Hydrate 4mg + Tolu Balsam 6mg, per 5913 5ml GS Syrup 160/042 Vigor Laboratories 586-A Mody Estates, Vardavit Syrup Multivitamins 5914 India Benzathine Penicillin 2.4MU Benzathine Penicillin POM Powder for 160/043 Vigor Laboratories 586-A Mody Estates, 5915 Injection 2.4MU Injection India Dexamethasone 5mg + POM Ear/Eye Drops 160/044 Vigor Laboratories 586-A Mody Estates, Dexamycin Eye/Ear Drops 5916 Neomycin 1mg, per ml India Aspirin 500 + Caffeine GS Tablet Uncoated 160/045 Vigor Laboratories 586-A Mody Estates, Mr. Power 500 Tablets 5917 30mg India POM Powder for 160/046 Vigor Laboratories 586-A Mody Estates, Benzyl Peniciliin 5MU Injection Benzyl Penicillin 5MU 5918 Injection India POM Solution for 160/047 Vigor Laboratories 586-A Mody Estates, Quinine Injection Quinine 300mg 5919 Injection India GS Suspension for 160/048 Vigor Laboratories 586-A Mody Estates, Anti-Diar Suspension Light Kaolin + Pectin 5920 Oral Use India

Page 304 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER POM Tablet Uncoated 160/049 Vigor Laboratories 586-A Mody Estates, Ciprofin 250 Tablets Ciprofloxacin 250mg 5921 India POM Tablet Uncoated 160/050 Vigor Laboratories 586-A Mody Estates, Ciprofin 500 Tablets Ciprofloxacin 500mg 5922 India POM Capsule oral 160/051 Vigor Laboratories 586-A Mody Estates, Syamoxil 500 Capsules Amoxicillin 500mg 5923 India POM Tablet Uncoated 160/052 Vigor Laboratories 586-A Mody Estates, Cimedine 200 Tablets Cimetidine 200mg 5924 India POM Capsule oral 160/053 Vigor Laboratories 586-A Mody Estates, Rifa 300 Capsules Rifampicin 300mg 5925 India GS Tablet Uncoated 160/054 Vigor Laboratories 586-A Mody Estates, Paladol Tablets Paracetamol 500mg 5926 India Chloramphenicol POM Ear/Eye Drops 160/056 Vigor Laboratories 586-A Mody Estates, Chlorphen Eye/Ear Drops 5927 0.5%w/v India Chlorpheniramine 2mg, P Suspension 160/057 Vigor Laboratories 586-A Mody Estates, Chlorpheniramine Suspension 5928 per 5ml India POM Eye Drops 160/058 Vigor Laboratories 586-A Mody Estates, Tetracycline Eye Drops Tetracycline 1%w/v 5929 India P Cream Topical 160/059 Vigor Laboratories 586-A Mody Estates, Betnovate Cream Betamethasone 1.0%w/v 5930 India Metronidazole BP 200mg POM Tablet Uncoated 160/060 Vigor Laboratories 586-A Mody Estates, Diarstop Tablets + Furazolidone BP India 5931 100mg POM Tablet Uncoated 160/061 Vigor Laboratories 586-A Mody Estates, Cimedine 400 Tablets Cimetidine 400mg 5932 India POM Tablet Uncoated 160/062 Vigor Laboratories 586-A Mody Estates, Wintogram 500 Tablets Nalidixic Acid 500mg 5933 India GS Tablet Uncoated 160/063 Vigor Laboratories 586-A Mody Estates, Ferenol 500 Tablets Paracetamol 500mg 5934 India GS Tablet Uncoated 160/064 Vigor Laboratories 586-A Mody Estates, Dawanol 500 Tablets Paracetamol BP 500mg 5935 India Nystatin 100,000 IU, per POM Suspension for 160/065 Vigor Laboratories 586-A Mody Estates, Nystatin Oral Suspension 5936 ml Oral Use India POM Tablet Uncoated 160/066 Vigor Laboratories 586-A Mody Estates, Salbuta 4 Tablets Salbutamol 4mg 5937 India Go Coff Cough Syrup P Syrup 160/067 Vigor Laboratories 586-A Mody Estates, Go Coff Cough syrup 5938 315.5mg, per 100ml India

Page 305 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER GS Powder for Oral 160/068 Vigor Laboratories 586-A Mody Estates, Sodium Chloride BP 2.9g Solution India + Potassium Chloride BP Vardhaman ORS Powder 1.5g + Glucose Anhydrous BP 20g + Orange Flavour 0.05g 5939 P Capsule oral 160/069 Vigor Laboratories 586-A Mody Estates, Get-On Capsules Herbal Extracts 5940 India P Capsule oral 160/070 Vigor Laboratories 586-A Mody Estates, Jeritone E Capsules Minerals + Multivitamins 5941 India POM Tablet Uncoated 160/071 Vigor Laboratories 586-A Mody Estates, Powerfil 50 Tablets Sildenafil 50mg 5942 India GS Tablet Uncoated 160/072 Vigor Laboratories 586-A Mody Estates, Vardavit Plus Tablets Multivitamins 5943 India GS Syrup 160/073 Vigor Laboratories 586-A Mody Estates, Supertone Syrup Multivitamin 5944 India Ethyl Alcohol 66.5%w/v GS Gel Topical 068/001 Virchow Healthcare Ltd, India Instaclenz Hand Gel + Isopropyl Alcohol 5945 3.5%v/v Cabonyl Iron 50mg + P Capsule oral 068/002 Virchow Healthcare Ltd, India Zinc Sulphate Vife-Z Monohydrate 61.8mg + 5946 Folic Acid 0.5mg 5947 Viprax 200 Tablets Cefixime Tables 200mg POM Tablet Uncoated 068/003 Virchow Healthcare Ltd, India 5948 Viprax-Dt 100 Cefixime Tablets 100mg POM Tablet Uncoated 068/004 Virchow Healthcare Ltd, India 5949 Osteocare Tablets Minerals + Vitamins P Tablet Uncoated 236/001 Vitabiotics Limited, England 5950 Immunace Capsules Multivitamins GS Capsule oral 236/002 Vitabiotics Limited, England 5951 Perfectil Capsules Minerals + Vitamins P Capsule oral 236/003 Vitabiotics Limited, England Ferroglobin B12 Syrup P Syrup 236/004 Vitabiotics Limited, England Ferroglobin B12 Syrup 5952 717.45mg

Page 306 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Soya Bean Oil (from P Capsule oral 236/005 Vitabiotics Limited, England Soya), Wheat-Germ Oil, Vitamin C (Ascorbic Acid), Methionine, Magnesium Oxide, L- Lysine HCl, Cod Liver Oil (from Fish), Omega-3 Fish Oil (from Fish), Ferrous Fumarate, Zinc Sulphate, Lecithin (contains Soya Bean Oil) (from Soya), Hard Vegetable Prep., Vitamin E (as DL-Alpha Tocopheryl Acetate Omega H3 Capsules Prep.), Inositol, Para- Aminobenzoic Acid, Thiamin (Vitamin B1 Mononitrate), Niacin (as Nicotinamide), Garlic Concentrate (Grapeseed Oil), Natural Mixed Carotenoids (Betacarotene, Alpha- Carotene, Cryptoxanthin, Zeaxanthin, Lutein, [Carrier; Olive Oil]), Pantothenic Acid (as Calcium Salt), Vitamin 5953 B12 (as Cyanocobalamin, 5954 Wellwoman Capsules Minerals + Vitamins P Capsule oral 236/006 Vitabiotics Limited, England 5955 Wellman Capsules Minerals + Vitamins P Capsule oral 236/007 Vitabiotics Limited, England 5956 Visionace Capsules Minerals + Vitamins P Capsule oral 236/008 Vitabiotics Limited, England 5957 Cardioace Capsules Minerals + Vitamins P Capsule oral 236/009 Vitabiotics Limited, England 5958 Jointace Capsules Minerals + Vitamins P Capsule oral 236/010 Vitabiotics Limited, England 5959 Diabetone Capsules Minerals + Vitamins P Capsule oral 236/011 Vitabiotics Limited, England 5960 Feroglobin B12 Capsules Minerals + Vitamins P Capsule oral 236/012 Vitabiotics Limited, England 5961 Neurozan Capsules Minerals + Vitamins P Capsule oral 236/013 Vitabiotics Limited, England 5962 Jointace Omega -3 Capsules Multivitamins GS Capsule oral 236/014 Vitabiotics Limited, England

Page 307 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Vitamins + Minerals + P Capsule oral 236/015 Vitabiotics Limited, England Liveril Capsules 5963 Amino Acids VITAHEALTH OMEGA 3 Pure Fish Oil 335mg + Omega P Capsule oral 453/001L Vitahealth Limited Fish Oils with Vitamin A & D 3 200mg + EPA 113mg Capsules + DHA 59mg + Vitamin A 400mcg + Vitamin D 5964 2mcg VITAHEALTH Jointcare Fortified Fish Oil 750mg + Omega P Capsule oral 453/002L Vitahealth Limited Capsules 3 500mg + EPA 283mg + DHA 142mg + Glucosamine 250mg + Vitamin C + 30mg + 5965 Vitamin D 5mcg 5966 Vital Multime Capsules Multivitamins GS Capsule oral 191/001 Vital Health Foods (Pvt) Ltd, South Africa 5967 Vital Dolomite 200's Tablets Vitamin D3 + Dolomite P Tablet Film coated 191/002 Vital Health Foods (Pvt) Ltd, South Africa 5968 Multitime Potency Capsules Multivitamins GS Capsule oral 191/003 Vital Health Foods (Pvt) Ltd, South Africa Vitane's Nature Evening GS Capsule oral 300/001 Vitane Pharmaceuticals Pvt Ltd, India Primrose Oil 1000mg 5969 Primrose Oil Softgels 1000mg P Capsule oral 300/002 Vitane Pharmaceuticals Pvt Ltd, India Probiotane Capsules Lactobacilli Culture 36mg 5970 Vitane's Nature Kids Plus GS Tablet Chewable 300/003 Vitane Pharmaceuticals Pvt Ltd, India Multivitamins 5971 Tablets Vitane's Nature Vitamin E 400iu POM Capsule oral 300/004 Vitane Pharmaceuticals Pvt Ltd, India Alpha Tocopheryl 400IU 5972 Softgels GS Capsule oral 300/005 Vitane Pharmaceuticals Pvt Ltd, India Omegavyte Liquicaps Omega-3 Fish Oil 600mg 5973 5974 Igra 100 Oral Jelly Sildenafil Citrate100mg POM Tablet Film coated 395/001 VV Labs Pvt. Ltd Amoxicillin Trihydrate POM Powder for Oral 243/001 VVS Pharmaceuticals and Chemicals (P) Vivamox Suspension 5975 125mg, per 5ml Suspension Ltd,India Amoxicillin Trihydrate POM Capsule oral 243/002 VVS Pharmaceuticals and Chemicals (P) Vivamox Capsules 5976 250mg Ltd,India POM Tablet Film coated 243/003 VVS Pharmaceuticals and Chemicals (P) Vigrex D5 Tablets Sildenafil Citrate 100mg 5977 Ltd,India Nystatin 500000 IU, per POM Solution for 243/004 VVS Pharmaceuticals and Chemicals (P) Vecostatin Injection 5978 5ml Injection Ltd,India POM Gel Topical 243/005 VVS Pharmaceuticals and Chemicals (P) Inal Gel Diclofenac Sodium 1mg 5979 Ltd,India 5980 Salbutamol Syrup Salbutamol 2mg, per 5ml POM Syrup 104/001 VYKing Pharmaceuticals Ltd, Lusaka

Page 308 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Trimethoprim 200mg + POM Suspension for 104/005 VYKing Pharmaceuticals Ltd, Lusaka Kotrim Suspension Sulphamethoxazole Oral Use 5981 40mg Sodium Bicarbonate GS Suspension for 104/006 VYKing Pharmaceuticals Ltd, Lusaka 500mg, per 5ml + Oral Use Magnesium Trisilicate Magnesium Trisilicate Mixture 500mg, per 5ml + Light Magnesium Oxide 5982 500mg, per 5ml Salicylic Acid 3% + P Ointment topical 104/012 VYKing Pharmaceuticals Ltd, Lusaka Whitefield’s Ointment 5983 Benzoic Acid 6% Peppermint Oil 0.003ml + GS Tablet Uncoated 104/018 VYKing Pharmaceuticals Ltd, Lusaka Dried Aluminium Antacid Tablets Hydroxide 120mg + Magnesium Trisilicate 5984 250mg Trimethoprim 400mg + POM Tablet Uncoated 104/020 VYKing Pharmaceuticals Ltd, Lusaka Kotrim Tablets Sulphamethoxazole 5985 80mg Acetyl Salicylic Acid P Tablet Uncoated 104/030 VYKing Pharmaceuticals Ltd, Lusaka Aspirin Tablets 5986 300mg 5987 Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 104/031 VYKing Pharmaceuticals Ltd, Lusaka 5988 Mebendazole Tablets Mebendazole 100mg P Tablet Uncoated 104/032 VYKing Pharmaceuticals Ltd, Lusaka P Syrup 104/034 VYKing Pharmaceuticals Ltd, Lusaka Diphenhydramine 12.5mg + Paracetamol Triphen 4 Flu Syrup 500mg + Pseudoephedrine 22.5mg 5989 5990 Pharmadol Tablets Paracetamol 100mg GS Tablet Uncoated 104/035 VYKing Pharmaceuticals Ltd, Lusaka DIOVOL Forte Oral Suspension Alumina 1.H. 300mg + P Suspension for 443/001 Wallace Pharmaceuticals Ltd Magnesia l.H. 250mg Oral Use +Simethicone 5991 l.P.40mq/5ml)

Page 309 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Dextromethophan P Syrup 220/001 Wardex Pharmaceuticals Pvt Ltd, India Hydrochloride 5mg, per 5ml + Chlorpheinramine Maleate BP 2.5mg, per Grilinctus Syrup 5ml + Guainephensin BP 50mg, per 5ml + Ammonium Chloride BP 5992 6mg, per 5ml Brohexine Hydrochloride P Syrup 220/002 Wardex Pharmaceuticals Pvt Ltd, India Grilintus BM Syrup 8mg + Terbutaline 5993 Sulphate 2.5mg Bromhexine P Syrup 220/003 Wardex Pharmaceuticals Pvt Ltd, India Hydrochloride 4mg + Grilinctus BM Pediatric Syrup Terbutaline Sulphate 5994 1.5mg Ferric Ammonium Citrate P Syrup 220/004 Wardex Pharmaceuticals Pvt Ltd, India Dexorange Syrup 160mg/15ml + 5995 Cyanocobalamin 7.5mg Solvent Ether 1.5%v/v + POM Solution for Oral 011/035 West-Coast Pharmaceutical Works, India Menthol 1.25w/v + Use Forache Toothache Solution Cajuput Oil 2.5%v/v+ Clove Oil 3.12%v/v + 5996 Tolu Balsum 1.25% Paradichlorobenzene P Solution for Topical 011/037 West-Coast Pharmaceutical Works, India 2%w/v + Benzocaine Use Waxnil Ear Drops 2.7% w/v + Chlorobutol 5.0% w/v + Turpentine 5997 2% w/v Dicyclomine 10mg + P Solution for Oral 011/039 West-Coast Pharmaceutical Works, India Pedicol Drops 5998 Dimethicone 133.32mg Use 5999 Wescovita Tablets Multivitamin P Tablet Uncoated 011/044 West-Coast Pharmaceutical Works, India 6000 Wescotone Syrup Multivitamin GS Syrup 011/045 West-Coast Pharmaceutical Works, India 6001 Demson Tablets Dexamethasone 0.5mg POM Tablet Uncoated 011/050 West-Coast Pharmaceutical Works, India P Tablet Uncoated 011/059 West-Coast Pharmaceutical Works, India Ferrous Sulphate 200mg Folfes Plus Tablets + Folic Acid 0.5mg 6002 Levamisole 15mg + P Suspension 011/062 West-Coast Pharmaceutical Works, India Levazid Suspension 6003 Oxyclozanide 30mg 6004 Mebenda Tablets Mebendazole 100mg P Tablet Uncoated 011/063 West-Coast Pharmaceutical Works, India

Page 310 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER P Solution for Oral 011/701 West-Coast Pharmaceutical Works, India Leva-Vet Solution Levamisole 15mg 6005 Use POM Tablet Uncoated 011/001 West-Coast Pharmaceutical Works, India, Welden-10 Tablet Piroxicam 10mg 6006 Lusaka POM Tablet Uncoated 011/002 West-Coast Pharmaceutical Works, India, Welden-20 Tablets Piroxicam 20mg 6007 Lusaka P Tablet Uncoated 011/003 West-Coast Pharmaceutical Works, India, Profen 200 Tablets Ibuprofen 200mg 6008 Lusaka P Tablet Uncoated 011/004 West-Coast Pharmaceutical Works, India, Profen 400 Tablets Ibuprofen 400mg 6009 Lusaka POM Tablet Uncoated 011/005 West-Coast Pharmaceutical Works, India, Samaol-2 Tablets Salbutamol 2mg 6010 Lusaka POM Tablet Uncoated 011/006 West-Coast Pharmaceutical Works, India, Samaol-4 Tablets Salbutamol 4mg 6011 Lusaka POM Tablet Uncoated 011/007 West-Coast Pharmaceutical Works, India, Ulcidin-200 Tablets Cimetidine 20mg 6012 Lusaka POM Tablet Uncoated 011/008 West-Coast Pharmaceutical Works, India, Metamide Tablets Metoclopramide 6013 Lusaka POM Tablet Uncoated 011/009 West-Coast Pharmaceutical Works, India, Tenil Tablets Atenolol 50mg 6014 Lusaka POM Tablet Uncoated 011/010 West-Coast Pharmaceutical Works, India, Tenil 100 Tablets Atenolol 100mg 6015 Lusaka P Tablet Uncoated 011/011 West-Coast Pharmaceutical Works, India, Clofen 25 Tablets Diclofenac 25mg 6016 Lusaka P Tablet Uncoated 011/012 West-Coast Pharmaceutical Works, India, Clofen 50 Tablets Diclofenac 50mg 6017 Lusaka Bromhexine P Tablet Uncoated 011/013 West-Coast Pharmaceutical Works, India, Hexin Tablets 6018 Hydrochloride IP 8mg Lusaka P Tablet Uncoated 011/014 West-Coast Pharmaceutical Works, India, Wescolax Tablets Bisacodyl 5mg 6019 Lusaka P Tablet Uncoated 011/015 West-Coast Pharmaceutical Works, India, Prodin Tablets Cyproheptadine 4mg 6020 Lusaka POM Tablet Uncoated 011/016 West-Coast Pharmaceutical Works, India, Nefed-5 Tablets Nifedipine 5mg 6021 Lusaka POM Tablet Uncoated 011/017 West-Coast Pharmaceutical Works, India, Nefed-10 Tablets Nifedipine 10mg 6022 Lusaka POM Lozenges 011/018 West-Coast Pharmaceutical Works, India, Clomzol Tablets Clotrimazole 10mg 6023 Lusaka

Page 311 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER POM Tablet Uncoated 011/019 West-Coast Pharmaceutical Works, India, Zepine Tablets Chlorpromazine 200mg 6024 Lusaka POM Tablet Uncoated 011/020 West-Coast Pharmaceutical Works, India, Tizole 150 Tablets Tinidazole 150mg 6025 Lusaka POM Tablet Uncoated 011/021 West-Coast Pharmaceutical Works, India, Tizole 300 Tablets Tinidazole 300mg 6026 Lusaka POM Tablet Uncoated 011/022 West-Coast Pharmaceutical Works, India, Tizole 500 Tablets Tinidazole 500mg 6027 Lusaka POM Tablet Uncoated 011/023 West-Coast Pharmaceutical Works, India, Glemide 2.5 Tablets Glibenclamide 2.5mg 6028 Lusaka POM Tablet Uncoated 011/024 West-Coast Pharmaceutical Works, India, Glemide 5 Tablets Glibenclamide 5mg 6029 Lusaka Aluminium Hydrochloride GS Suspension for 011/025 West-Coast Pharmaceutical Works, India, Dawacid Suspension 625mg + Magnesium Oral Use Lusaka 6030 Trisilicate 312mg Metronidazole 200mg, POM Suspension for 011/026 West-Coast Pharmaceutical Works, India, Wescogyl Oral Suspension 6031 per 5ml Oral Use Lusaka POM Tablet Vaginal 011/027 West-Coast Pharmaceutical Works, India, Nytin Pessaries Nystatin 100,000IU 6032 Lusaka Aluminium Hydrochloride GS Tablet Uncoated 011/028 West-Coast Pharmaceutical Works, India, Allucid Tablets 250mg + Magnesium Lusaka 6033 Trisilicate 120mg Promethazine 5mg, per P Syrup 011/029 West-Coast Pharmaceutical Works, India, Wamargan Syrup 6034 5ml Lusaka Loperamide POM Capsule oral 011/030 West-Coast Pharmaceutical Works, India, Loptil Capsules 6035 Hydrocholride 2mg Lusaka ORS (Sodium Chloride + POM Powder for Oral 011/031 West-Coast Pharmaceutical Works, India, Sodium Citrate + Solution Lusaka Oralyt Powder Potassium Chloride + 6036 Glucose) B Complex (Vit B1 1mg + P Tablet Uncoated 011/032 West-Coast Pharmaceutical Works, India, B-Covit Tablets B2 1mg + Niacinamide Lusaka 6037 10mg) POM Syrup 011/033 West-Coast Pharmaceutical Works, India, Samol Syrup Salbutamol 2mg, per 5ml 6038 Lusaka POM Tablet Uncoated 011/034 West-Coast Pharmaceutical Works, India, Sulfamethoxazole 400mg Bacrizole 480 Tablets Lusaka + Trimethoprim 80mg 6039

Page 312 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER POM Cream Topical 011/036 West-Coast Pharmaceutical Works, India, Kezol Cream Ketoconazole 2%w/w 6040 Lusaka Chloramphenicol 5%w/v POM Ear Drops 011/038 West-Coast Pharmaceutical Works, India, + Beclomethasone Lusaka OTO-4 Ear Drops Dipropionate 0.025%w/v 6041 + Clotrim 1%w/v P Tablet Uncoated 011/040 West-Coast Pharmaceutical Works, India, Phenamine Tablets Chlopheniramine 4mg 6042 Lusaka Hyoscine Butylbromide POM Tablet Uncoated 011/041 West-Coast Pharmaceutical Works, India, Spasminal Tablets 6043 10mg Lusaka P Nasal drops 011/042 West-Coast Pharmaceutical Works, India, Xylone Nasal Drops (Paed) Xylometazoline 0.05%w/v 6044 Lusaka P Nasal drops 011/043 West-Coast Pharmaceutical Works, India, Xylone Nasal Drops (Adult) Xylometazoline 0.1%w/v 6045 Lusaka P Tablet Uncoated 011/046 West-Coast Pharmaceutical Works, India, Asbic-100 Tablets Ascorbic Acid 100mg 6046 Lusaka Acetylsalicylic Acid P Tablet Uncoated 011/047 West-Coast Pharmaceutical Works, India, ASP-300 Tablets 6047 300mg Lusaka POM Tablet Uncoated 011/048 West-Coast Pharmaceutical Works, India, Etoin -100 Tablets Phenytoin 100mg 6048 Lusaka POM Tablets oral 011/049 West-Coast Pharmaceutical Works, India, Eril-10 Tablets Enalapril 10mg 6049 Lusaka Ciprofloxacin 250mg + POM Suspension for 011/051 West-Coast Pharmaceutical Works, India, CT-Suspension 6050 Tinidazole 300mg Oral Use Lusaka Chlorpheniramine 2.5mg P Syrup 011/052 West-Coast Pharmaceutical Works, India, + Ammonium Chloride Lusaka Cofnil Syrup 125mg + Soduim Citrate 6051 +125mg P Tablet Uncoated 011/053 West-Coast Pharmaceutical Works, India, Cetri-10 Tablets Cetirizine 10mg 6052 Lusaka Trimethoprim 40mg + POM Suspension for 011/054 West-Coast Pharmaceutical Works, India, Bactrizole Suspension Sulphamethoxazole Oral Use Lusaka 6053 200mg Niacinamide 50mg + P Tablet Uncoated 011/055 West-Coast Pharmaceutical Works, India, B-Folcin Tablets Riboflavin 10mg + Folic Lusaka 6054 Acid 1.5mg P Suspension for 011/056 West-Coast Pharmaceutical Works, India, Azolevet Suspension Albendazole 25mg/Ml 6055 Oral Use Lusaka

Page 313 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Acetaminophen 250mg + GS Tablet Uncoated 011/058 West-Coast Pharmaceutical Works, India, Forache Tablets Caffeine 30mg + Aspirin Lusaka 6056 300mg P Tablet Uncoated 011/060 West-Coast Pharmaceutical Works, India, Fesate Tablets Ferrous Sulphate 200mg 6057 Lusaka P Syrup 011/061 West-Coast Pharmaceutical Works, India, Ferolax Syrup Haematinic 6058 Lusaka Diclomol Injection Diclofenac Sodium POM Solution for 452/001 Win-Medicare Pvt Ltd 6059 25mg/ml Injection Urgendol Injection Tramadol Hydrochloride POM Solution for 452/002 Win-Medicare Pvt Ltd 6060 50mg/ml Injection Glucose Intravenous POM Solution for 124/001 Wockhardt Limited, India Glucose Intravenous Infusion 6061 Infusion B.P 5%w/v infusion Glucose Intravenous POM Solution for 124/002 Wockhardt Limited, India Glucose Intravenous Infusion 6062 Infusion B.P 10%w/v infusion Sodium Chloride POM Solution for 124/003 Wockhardt Limited, India 0.6%w/v + Calcium infusion Compound Sodium Lactate Chloride 0.027g w/v + Injection Potassium Chloride 0.04%w/v + Sodium 6063 Lactate 0.24%w/v 6064 Pelox-400 Tablets Perfloxacin 400mg POM Tablet Uncoated 124/004 Wockhardt Limited, India Metronidazole 5mg, per POM Solution for 124/005 Wockhardt Limited, India Metronidazole Injection 6065 ml infusion GS Solution for Oral 124/006 Wockhardt Limited, India Wokadine Germicide Gargles Povidone Iodine 1% 6066 Use 6067 Wokadine Vaginal Pesseries Povidone Iodine 200mg POM Tablet Vaginal 124/007 Wockhardt Limited, India Bromhexine 4mg + POM Syrup 124/008 Wockhardt Limited, India Dextromethorphan 5mg + Zedex Cough Syrup Ammonium Chloride 50mg + Menthol 2.5mg, 6068 per 100ml POM Solution for 124/009 Wockhardt Limited, India Soduim Chloride Injection Sodium Chloride 0.9% 6069 infusion 6070 Aziwork USP Capsules Azithromycin 250mg POM Capsule oral 124/010 Wockhardt Limited, India Terbutaline 1.25mg + POM Syrup 124/011 Wockhardt Limited, India Bromhexine 4mg + Bro-Zedex Cough Syrup Guaifenesin 50mg + 6071 Menthol 2.5mg, per 5ml

Page 314 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Azithromycin 100mg, per POM Suspension for 124/012 Wockhardt Limited, India Aziwork Suspension 6072 5ml Oral Use Dextropropoxyphen POM Capsule oral 124/013 Wockhardt Limited, India Proxyvon Capsules 65mg + Paracetamol 6073 400mg 6074 Pelox-400 Tablets Perfloxacin 400mg POM Tablet Uncoated 124/014 Wockhardt Limited, India GS Ointment topical 124/015 Wockhardt Limited, India Wokadine 10%w/w Ointment Povidone Iodine 10%w/w 6075 POM Powder for 124/016 Wockhardt Limited, India Powercef 125mg Injection Ceftriaxone 125mg 6076 Injection POM Powder for 124/017 Wockhardt Limited, India Powercef 250 Injection Ceftriaxone 250mg 6077 Injection POM Powder for 124/018 Wockhardt Limited, India Powercef 500mg Injection Ceftriaxone 500mg 6078 Injection POM Powder for 124/019 Wockhardt Limited, India Powercef 1000mg Injection Ceftriaxone 1000mg 6079 Injection 6080 Sparx-200 Tablets Sparfloxacin 200mg POM Tablet Uncoated 124/020 Wockhardt Limited, India Recombinant Human POM Solution for 124/021 Wockhardt Limited, India Wepox 2000 Injection Erythropoietin 2000 IU, Injection 6081 per ml 6082 Nadoxin Cream Nadifloxacin 1%w/v POM Cream Topical 124/022 Wockhardt Limited, India POM Solution for 124/023 Wockhardt Limited, India Wosulin-R Injection Insulin EP 100 IU, per ml 6083 Injection Recombinant (R-DNA) POM Solution for 124/024 Wockhardt Limited, India Human Insulin Biphasic Injection Wosulin 30/70 Injection 30% Regular/70% 6084 Isophane Recombinant (R-DNA) POM Solution for 124/025 Wockhardt Limited, India Wosulin N Injection 30% Human Insulin NPH - Injection 6085 Intermediate Acting Promethazine 50mg, per POM Solution for 028/001MT Wuhan Grand Pharmaceutical Group Co. Promethazine Injection 6086 2ml Injection Ltd Chlorpromazine 25mg, POM Solution for 028/002MT Wuhan Grand Pharmaceutical Group Co. Chlorpromazine Injection 6087 per ml Injection Ltd Metoclopramide 10mg, POM Solution for 028/003MT Wuhan Grand Pharmaceutical Group Co. Metoclopromide Injection 6088 per 2ml Injection Ltd POM Solution for 033/027 Wuhan Grand Pharmaceutical Group Co. Oxytocin Injection Oxytocin 10 IU 6089 Injection Ltd

Page 315 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Sodium Chloride 3.5g + GS Powder for Oral 033/028 Wuhan Grand Pharmaceutical Group Co. Potassium Chloride 1.5g Solution Ltd Oral Rehydration Salts + Sodium Citrate 2.9g + 6090 Anhydrous Glucose 20g P Medical Device 386/001L Wuhu Snnda Medical Treatment Appliance Shangring Male Circumcision Shangring Male Device With Removal Tool & Circumcision Device with Band Aid Removal Tool & Band 6091 6092 Premarin Tablets Oestrogen 0.3mg POM Tablet Uncoated 116/005 Wyeth Laboratories (Pty) Limited, SA Ibuprofen 200mg + P Tablet Uncoated 120/033 Wyeth Laboratories (Pty) Limited, SA Advil CS Tablets Pseudoephedrine 6093 Hydrochloride 30mg Aspirin 400mg + Caffeine GS Tablet Uncoated 120/034 Wyeth Laboratories (Pty) Limited, SA Anadin Tablets 6094 22.7mg Yeast Cell Extract + 3g P Ointment topical 120/035 Wyeth Laboratories (Pty) Limited, SA Preparation H Ointment Shark Liver Oil + 1g 6095 Alcohol, per 100g Petrolatum71.9% + P Suppository 120/036 Wyeth Laboratories (Pty) Limited, SA Mineral Oil 14% + Shark Preparation H Suppositories Liver Oil 3% + Phenylephedrine 6096 Hydrochloride 0.25% 6097 Valizgy Eczema Cream Betamethasone 1% POM Cream Topical 216/001 Yash Pharmaceuticals Ltd 6098 Herpizyg Cream Acyclovir 5 % POM Cream Topical 216/002 Yash Pharmaceuticals Ltd Clotrimazole 1%w/w + POM Cream Topical 216/003 Yash Pharmaceuticals Ltd Butate Antifungal Cream 6099 Benzyl Alcohol 1%w/w Betamethasone POM Cream Topical 216/004 Yash Pharmaceuticals Ltd Dipvite Cream 6100 0.643mg/g POM Solution for Topical 216/005 Yash Pharmaceuticals Ltd Naftol Topical Solution Tolnaftate 10mg 6101 Use Clotrimazole 10mg + POM Cream Topical 216/006 Yash Pharmaceuticals Ltd Clodip Cream Betamethasone 0.643mg, 6102 per g

Page 316 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Betamethasone POM Cream Topical 216/007 Yash Pharmaceuticals Ltd Dipropionate 0.64mg + Clotrimazole 10mg + Fosure Cream Gentamicin Base 1 mg + Tolnaftate 10 Mg + Iodochlorhydroxyquinolin 6103 e 10mg Salicylic Acid 30mg + POM Ointment topical 216/009 Yash Pharmaceuticals Ltd Epiklin Ointment 6104 Betamethasone 0.64mg Nystatin 100,000 I.U + POM Cream Topical 216/010 Yash Pharmaceuticals Ltd Naftatin Cream 6105 Tolnaftate 10mg 6106 Yashiprostol - 200 Tablets Misoprostol 200mcg POM Tablet Uncoated 349/001 Yashika Pharmaceuticals Pvt Ltd Oxytocin USP 10IU, per POM Solution for 349/002 Yashika Pharmaceuticals Pvt Ltd Oxytocin Injection USP 10 IU/Ml 6107 ml Injection 6108 Gummi King Vitamin C Gummi Ascorbic Acid 30mg P Gel Oral 411/001L Zanon USA Inc. d.b.a. Vitamec USA Inc Gummi King Multivitamin & P 411/002L Multivitamins & Minerals Gel Oral Zanon USA Inc. d.b.a. Vitamec USA Inc 6109 Mineral Gummi Gummi King Calcium Plus Calcium 50mg + Vitamin P 411/003L Gel Oral Zanon USA Inc. d.b.a. Vitamec USA Inc 6110 +Vitamin D Gummi D 0.00006mg Echinacea 25mg + P 411/004L Gummi King Echinacea Plus Ascorbic Acid 15mg + Gel Oral Zanon USA Inc. d.b.a. Vitamec USA Inc Vitamin C & Zinc Gummi 6111 Zinc 2.5mg 6112 Gummi King Vitamin D Gummi. Vitamin D 0.01mg P Gel Oral 411/005L Zanon USA Inc. d.b.a. Vitamec USA Inc Valeriana Officinalis Root GS Tablet Uncoated 052/001 Zifam Pinnacle Pty Ltd, Australia Siesta Tablets 6113 Extract 2g Chromium Picolinate GS Tablet Uncoated 052/001L Zifam Pinnacle Pty Ltd, Australia Pinch Tablets 6114 50mcg + Sucralose 8mg Gamma Linolenic Acid GS Capsule oral 052/002 Zifam Pinnacle Pty Ltd, Australia Eposoft Gelatin Capsules 6115 100mg 6116 Supravit Tablets Minerals + Multivitamins P Tablet Uncoated 052/003 Zifam Pinnacle Pty Ltd, Australia Phaseolus Vulgaris P Capsule oral 052/004 Zifam Pinnacle Pty Ltd, Australia Lobese Capsules 6117 Extract 500mg 6118 Vitacee Tablets Ascorbic Acid 500mg GS Tablet Uncoated 052/005 Zifam Pinnacle Pty Ltd, Australia D-Alpha-Tocopherol POM Tablet Uncoated 052/006 Zifam Pinnacle Pty Ltd, Australia Vibran Tablets 6119 82.6mg GS Caplets oral 052/007 Zifam Pinnacle Pty Ltd, Australia Protec Caplets Multivitamins 6120 Uncoated

Page 317 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Eicosapentaenoic Acid P Capsule oral 052/008 Zifam Pinnacle Pty Ltd, Australia Mega 3 Fish Oil Concentrate 180mg + Capsules Ocosahexaenoic Acid 6121 120mg 6122 Vitakid Tablets Minerals + Multivitamins P Tablet Chewable 052/009 Zifam Pinnacle Pty Ltd, Australia Milk Calcium 600mg + P Tablet Uncoated 052/010 Zifam Pinnacle Pty Ltd, Australia Ozical Tablets 6123 Vitamin D3 0.5mg Colostrum Powder P Capsule oral 052/011 Zifam Pinnacle Pty Ltd, Australia Immunor Capsules Bovine75mg+ Lactoferrin 6124 Bovin 100mg Hypericum Perforatum P Tablet Uncoated 052/012 Zifam Pinnacle Pty Ltd, Australia Zifam St Johns Wort Tablets 6125 1800mg Amino Acids + Vitamins P Tablet Uncoated 052/013 Zifam Pinnacle Pty Ltd, Australia Amino-XL Tablets 6126 & Minerals P Caplets oral 052/014 Zifam Pinnacle Pty Ltd, Australia Vitrum Tablets Minerals + Multivitamins 6127 Uncoated G-Trim Powder (Lime & Lemon P Powder for Oral 052/015L Zifam Pinnacle Pty Ltd, Australia Herbal Preparation 6128 Flavour) Solution Fish Oil Natural (Eq. To P Capsule oral 052/016L Zifam Pinnacle Pty Ltd, Australia Mega 3 Chewable Softgels Docosahexaenoic Acid 6129 )750mg 6130 Natocare Softgels Fish Oil Natural 800mg P Capsule oral 052/017L Zifam Pinnacle Pty Ltd, Australia Tribulus Terrestris 250mg P Tablet Uncoated 052/018L Zifam Pinnacle Pty Ltd, Australia + Avena Sativa Extract Tribull Tablets 10mg + Zinc Sulphate 6131 40mg Cee Lime N Lemon Chewable GS Tablet Chewable 052/019L Zifam Pinnacle Pty Ltd, Australia Vitamin C 500mg 6132 Tablets 6133 Cee Orange Chewable Tablets Vitamin C 500mg GS Tablet Chewable 052/020L Zifam Pinnacle Pty Ltd, Australia Black Cohosh 200mg + P Capsule Hard 052/021L Zifam Pinnacle Pty Ltd, Australia Menofem Capsules 6134 Red Clover 1g Gelatin 6135 Emuflam Cream Herbal Extracts GS Cream Topical 052/022L Zifam Pinnacle Pty Ltd, Australia Glucosamine Sulphate GS Capsule Hard 052/023L Zifam Pinnacle Pty Ltd, Australia Nuflam Capsules 667mg + Chondroitin Gelatin 6136 278mg 6137 Cee Pineapple Tablets Vitamin C 500mg GS Tablet Chewable 052/024L Zifam Pinnacle Pty Ltd, Australia 6138 Cee Strawberry Tablets Vitamin C 500mg GS Tablet Chewable 052/025L Zifam Pinnacle Pty Ltd, Australia 6139 Gaseze Softgels Combination P Capsule, soft 052/026L Zifam Pinnacle Pty Ltd, Australia 6140 Infant Coleze Softgels Combination P Capsule, soft 052/027L Zifam Pinnacle Pty Ltd, Australia

Page 318 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Vaccinum Macrocarpon P Powder for oral 052/028L Zifam Pinnacle Pty Ltd, Australia Urisol Sachets 6141 360mg Iron 24mg + Vitamin C P Capsule, Hard 052/029L Zifam Pinnacle Pty Ltd, Australia 100mg + Vitamin B12 gelatin Ferosorb Capsules 500mcg + Folic Acid 6142 500mcg OPTICA Capsules Lutein esters calculated P Capsule oral 052/039L Zifam Pinnacle Pty Ltd, Australia as Lutein 5.6mg + Zeaxanthin 324mg + R,S- 6143 Alpha Lipoic Acid 250mg NATOCARE PLUS DHA 125mg with P Capsule oral 052/040L Zifam Pinnacle Pty Ltd, Australia 6144 Multivitamins ZI LIV Capsules Silybum marianum 7.5g + P Capsule oral 052/038L Zifam Pinnacle Pty Ltd, Australia Taraxacum officiale 250mg + Schisandra chinensis extract 125mg + Astragalus membranaceus extract 100mg + Cynara scolymus 1.5g + Andrographis 500mg + Curcuma longa 1.5g Inositol 125mg + Choline bitartrate 125mg + Taurine 75mg + Ascorbic 6145 acid 50mg CINRO Tablets Cinnamomum cassia P Tablet Film coated 052/041L Zifam Pinnacle Pty Ltd, Australia extract 1g + Chromium Picolinate 50mcg + Chronium Chloride 50mcg + total elemental Chronium 200mcg + Ascorbic Acid 75mg + 6146 Biotin 5mg Pyrimethamine 3.125mg P Tablet Uncoated 091/001 Zimbabwe Pharmaceuticals (Pvt) Limited, Deltaprim Tablets 6147 + Dapsone 25mg Zimbabwe Dextromethorphan P Syrup 091/002 Zimbabwe Pharmaceuticals (Pvt) Limited, Betaco Syrup 6148 Hydrobromide 15mg/5ml Zimbabwe

Page 319 of 320 ZAMBIA MEDICINES REGULATORY AUTHORITY MEDICINES FOR HUMAN USE 2019 REGISTER Dextromethorphan 15mg, P Syrup 091/003 Zimbabwe Pharmaceuticals (Pvt) Limited, per 5ml + Zimbabwe Betafed Syrup Pseudoephedrine 30mg, 6149 per 5ml Guaiphenesin 100mg, P Syrup 091/004 Zimbabwe Pharmaceuticals (Pvt) Limited, Betamint Cough Syrup 6150 per 5ml Zimbabwe Paracetamol 120mg, per GS Syrup 091/005 Zimbabwe Pharmaceuticals (Pvt) Limited, Betamol Syrup 6151 5ml Zimbabwe P Syrup 091/006 Zimbabwe Pharmaceuticals (Pvt) Limited, Triprolidine 1.375mg, per Zimbabwe Betapro Syrup 5ml + Pseudoephedrine 30mg, per 5ml 6152 Dapsone 25mg + POM Syrup 091/007 Zimbabwe Pharmaceuticals (Pvt) Limited, Deltaprim Paediatric Syrup 6153 Pyrimethamine 3.125mg Zimbabwe Ranitidine Hydrochloride POM Tablet Uncoated 139/001 Zydus Cadila Healthcare Ltd, India R-Loc 150 Tablets 6154 150mg 6155 Tiniba 500 Tablets Tinidazole 500mg POM Tablet Uncoated 139/002 Zydus Cadila Healthcare Ltd, India 6156 Betanese 5 Tablets Glibenclamide 5mg POM Tablet Uncoated 139/003 Zydus Cadila Healthcare Ltd, India 6157 Amlodac-5 Tablets Amilodipine 5mg POM Tablet Uncoated 139/004 Zydus Cadila Healthcare Ltd, India 6158 Amilodac 10 Tablets Amilodipine 10mg POM Tablet Uncoated 139/005 Zydus Cadila Healthcare Ltd, India 6159 Piricam 10 Capsules Piroxicam 10mg POM Tablet Uncoated 139/006 Zydus Cadila Healthcare Ltd, India 6160 Piricam 20 Capsules Piroxicam 20mg POM Capsule oral 139/007 Zydus Cadila Healthcare Ltd, India 6161 Odace 5 Tablets Lisinopril Dihydrate 5mg POM Capsule oral 139/008 Zydus Cadila Healthcare Ltd, India 6162 Nilfast Suspension Nimesulide 50mg, per ml POM Tablet Uncoated 139/009 Zydus Cadila Healthcare Ltd, India POM Suspension for 139/010 Zydus Cadila Healthcare Ltd, India Cefotim 1000 Injection Cefotaxime 1000mg 6163 Oral Use POM Powder for 139/011 Zydus Cadila Healthcare Ltd, India Hipen Capsules Amoxicillin 250mg 6164 Injection 6165 Loridin Rapitas Tablets Loratadine 10mg POM Capsule oral 139/012 Zydus Cadila Healthcare Ltd, India 6166 Loridin Suspension Loratadine 5mg, per 5ml POM Tablet Uncoated 139/013 Zydus Cadila Healthcare Ltd, India P Suspension for 139/014 Zydus Cadila Healthcare Ltd, India Norswell Tablets Ibuprofen 200mg 6167 Oral Use Tramadol Hydrochloride POM Solution for 139/015 Zydus Cadila Healthcare Ltd, India Tramazac Injection 6168 50mg, per ml Injection Tramadol Hydrochloride P Tablet Uncoated 139/016 Zydus Cadila Healthcare Ltd, India Tramazac Capsules 6169 50mg 6170 Odace-10 Tablets Lisinopril 10mg POM Tablets Uncoated 139/017 Zydus Cadila Healthcare Ltd, India

Page 320 of 320