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