No. 3556 Government Gazette 16 December 2005 1

GOVERNMENT GAZETTE

OF THE REPUBLIC OF NAMIBIA

N$2.00 WINDHOEK - 16 December 2005 No. 3556

CONTENTS

Page GOVERNMENT NOTICE

No. 182 Notification of registration of certain medicines in terms of the Medicines and Related Substances Control Act, 1965 ...... 1

Government Notice

MINISTRY OF HEALTH AND SOCIAL SERVICES

No. 182 2005

NOTIFICATION OF REGISTRATION OF CERTAIN MEDICINES IN TERMS OF THE MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 1965

In terms of section 17 of the Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) (hereinafter referred to as the Act), I give notice that the medicines set out in the Schedule have been registered in terms of the Act, subject to the following conditions:

(a) the manufacture and control of the medicine must be in accordance with the existing Good Manufacturing Practices as required by the World Health Organisation;

(b) in order to assess compliance with paragraph (a), inspections and investigations may be carried out regularly by inspectors authorised in terms of section 26 of the Act;

(c) the information in the package insert must, on a regular basis, be updated to conform with the package insert approved by the council; 2 Government Gazette 16 December 2005 No. 3556

(d) the holder of the certificate of registration which is referred to in section 15(4) of the Act, must comply with the Act;

(e) the registration of the medicine is subject to regular review regarding its quality, safety and efficacy, and the council may, as it considers necessary, vary the registration of the medicine;

(f) the first two production batches must be validated in accordance with the detailed process validation protocol which was submitted at the time of the application for registration;

(g) a validation report must be submitted to the council within one month from the date of completion of the validation referred to in paragraph (f); and

(h) the council may review the registration dossier at such intervals as the council may determine.

J = / GAESEB REGISTRAR OF MEDICINES Windhoek, 30 November 2005

SCHEDULE No. 3556 Government Gazette 16 December 2005 3 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/2.5/0011 05/7.1.3/0005 05/7.1.3/0006 05/6.2/0007 05/2.5/0008 05/2.5/0009 05/2.5/0010 05/34/0012 05/8.2/0013 REG. NO. NAMIBIA 05/7.1.3/0001 05/7.1.3/0002 05/7.1.3/0003 0456.2/0004 Each tablet contains Sodium Valproate 133,2 mg, Valproic Acid 58,0 Acid Valproic 133,2 mg, Valproate Each tablet contains Sodium 200 mg Valproate equiv to Sodium 87,0 Acid Valproic 199,8 mg, Valproate Each tablet contains Sodium 300 mg Valproate equiv to Sodium 149,34 Acid Valproic 333 mg, Valproate Each tablet contains Sodium 500 mg Valproate equiv to Sodium Irbesartan Tablet, 75 mg Tablet, Irbesartan Amiodarone Hydrochloride 100,0 mg Each tablet contains Each vial contains Sodium Valproate 400,0mg Valproate Each vial contains Sodium for Injections 4,0 ml Water AXa 1900 IU Each 0,2 ml of solution contains Nadroparin Calcium STRENGTH/DOSE UNIT Irbesartan tablet, 150 mg Irbesartan tablet, 300 mg Adenosine 6 mg/2ml Injection 12,5 mg Each tablet contains Irbesartan 150 mg, Hydrochlorothiazide 12,5 mg Each tablet contains Irbesartan 300 mg, Hydrochlorothiazide SCHEDULE Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Freeze dried Powder Injection Injection DOSSAGE FORM Injection Sodium Valproate , Valproic Acid Valproic , Valproate Sodium Acid Valproic , Valproate Sodium Acid Valproic , Valproate Sodium Valproate Sodium for Injections Water APPROVED NAME OF APPROVED NAME OF Nadroparin Calcium Irbesartan Irbesartan Adenosine Irbesartan , Hydrochlorothiazide Irbesartan , Hydrochlorothiazide Amiodarone HCl ACTIVE(S) Irbesartan Water for Injection for Water Epilim CR200 Epilim CR300 Epilim CR500 Epilim Intravenous Epilim IV Fraxiparine 0,2 ml Aprovel 150 mg Aprovel 300 mg Adenocor Coaprovel 150/12,5 Coaprovel 300/12,5 Cordarone X100 REGISTERED NAME Aprovel 75 mg Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited APPLICANT Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) 4 Government Gazette 16 December 2005 No. 3556 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/8.2/0019 05/17.1/0020 05/8.2/0021 05/52.6.5/0022 05/52.6.5/0023 05/2.2/0024 05/5.2/0025 05/20.1.1/0026 05/20.1.1/0027 REG. NO. NAMIBIA 05/8.2/0014 04517.1/0015 05/8.2/0016 05/8.2/0017 05/8.2/0018 Each Tablet contains Amisulpride 50 mg contains Tablet Each Amisulpride 200 mg contains Tablet Each lm-coated tablet contains Clopidogrel Hydrogen Sulphate equiv. Each film-coated tablet contains Clopidogrel Hydrogen Hemitatrate 10 mg contains Zolpidem Tablet Each Atenolol 25 mg contains Tablet Each Each 0,3 ml of solution contains Nadroparin Calcium 2850 IU AXa contains Nadroparin Calcium 2850 IU Each 0,3 ml of solution AXa contains Nadroparin Calcium 3800 IU Each 0,4 ml of solution AXa contains Nadroparin Calcium 5700 IU Each 0,6 ml of solution AXa 7600 IU Each 0,8 ml of solution contains Nadroparin Calcium AXa 9500 IU Each 1,0 ml of solution contains Nadroparin Calcium Bromide 10,0mg Vecuronium Each vial of freeze dried powder contains equiv to Meropenem Trihydrate Each vial contains Meropenem equiv to Trihydrate Each vial of Injection contains Meropenem Anhydrous 500 mg Meropenem Anhydrous 1000 mg STRENGTH/DOSE UNIT injection contains Rocuronium Each 5 ml solution for intravenus Bromide 50,0mg to Clopidogrel 75,0mg Tablets Tablets Tablets Tablets Tablets Injection Injection DOSSAGE FORM Injection Injection Injection Injection Injection Injection Injection Amisulpride Amisulpride Trihydrate Meropenem Trihydrate Meropenem Vecuronium Bromide Vecuronium APPROVED NAME OF APPROVED NAME OF Zolpidem Hemitatrate Atenolol Nadroparin Calcium Nadroparin Calcium Nadroparin Calcium Nadroparin Calcium Clopidogrel Hydrogen Sulphate ACTIVE(S) Nadroparin Calcium Rocuronium Bromide Tenormin 25 Tenormin Solian 50 mg Solian 200 Stilnox Meronem 1000 Meronem 500 Fraxiparine 0,4 ml Fraxiparine 0,6 ml Fraxiparine 0,8 ml Fraxiparine 1,0 ml Norcuron 10 mg Plavix REGISTERED NAME Fraxiparine 0,3 ml Esmeron 50 mg/5 ml - - AstraZeneca Pharma ceuticals (Pty) Ltd Ltd AstraZeneca Pharma ceuticals (Pty) Ltd Limited AstraZeneca Pharmaceuticals (Pty) Limited Limited Limited Limited Limited Limited Limited Limited Limited Limited APPLICANT Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) No. 3556 Government Gazette 16 December 2005 5 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/7.1/0033 05/30.1/0034 05/30.1/0035 05/30.1/0036 05/30.1/0037 05/30.1/0038 05/30.1/0039 REG. NO. NAMIBIA 05/2.1/0028 05/7.1.3/0029 05/7.1.3/0030 05/10.2.1/0031 05/7.1.4/0032 Each Tablet contains Lisinopril 20 mg, Hydrochlorthiazide 12,5 mg contains Lisinopril 20 mg, Hydrochlorthiazide Tablet Each 12,5 mg contains Lisinopril 10 mg, Hydrochlorthiazide Tablet Each 60 mg contains Isosorbide-5-Mononitrate Tablet Each mg contains Felodipine 5,0 Tablet Each Extended Release Each 240 ml of Liquid contains Desflurane 240 ml Desflurane Each 240 ml of Liquid contains 30 Toxoid Diphtheria Each immunising dose(0,5ml) contains; Purified toxoid 60 IU, Bordella Pertusis, inactivated Tetanus IU, Purified 40,0IU Toxoid Tetanus Each immunising dose contains Polysacharide of: Each immunising dose(0,5ml) contains Purified 50 µg, Neisseria Meningitdis Group C A Nisseria Meningitidis Group Each immunising dose contains Purified Vi capsular polysacharide of Vi Each immunising dose contains Purified 25 µg (ty 2 strain) Typhi Salmonella 50 µg STRENGTH/DOSE UNIT Formoterol Fumarate 9,0 µg Each delivered dose contains suspension > 4 IU units of inactivated Each immunising dose (0,5ml) contains 80 antigen virus A Hepatitis or greater than 2,5 IU Each immunising dose (0,5ml) is at least equal Lyophilised Lyophilised Lyophilised Lyophilised Tablets Tablets Tablets Lyophilised Tablets Suspension for Injection Powder for Injection DOSSAGE FORM Liquid for Inhalation Metered Dose Inhaler Suspension Suspension Powder for Injection Powder for Injection Antigen units of inactivated virus A Hepatitis capsular polysacharide Vi Purified (ty 2 strain) Typhi of Salmonella Toxoid Tetanus Inactivated Rabies Vaccine Inactivated Rabies Adsorbed Diphtheria, Tetanus and Tetanus Adsorbed Diphtheria, APPROVED NAME OF APPROVED NAME OF Desflurane Combination Lisinopril , Hydrochlorthiazide Lisinopril , Hydrochlorthiazide Formoterol Fumarate Isosorbide-5-Mononitrate Felodipine Pertusis vaccine ACTIVE(S) Lisinopril , Hydrochlorthiazide Imovax Meningo A+C Imovax Meningo Avaxim 80 Avaxim Vi Typhim Tetavax Oxis Turbuhaler 9 Turbuhaler Oxis Merieux Inactivated Vaccine Rabies Zestoretic 10 Imdur 60 mg Plendil 5 mg DTP-Merieux REGISTERED NAME Suprane Zestoretic 20 ------Limited Limited Limited Limited Limited Limited ceuticals (Pty) Ltd AstraZeneca Pharma ceuticals (Pty) Ltd AstraZeneca Pharma ceuticals (Pty) Ltd AstraZeneca Pharma ceuticals (Pty) Ltd AstraZeneca Pharma ceuticals (Pty) Ltd AstraZeneca Pharma ceuticals (Pty) Ltd AstraZeneca Pharma APPLICANT Aventis Pharma (Pty) Aventis Pharma (Pty) Aventis Pharma (Pty) Aventis Pharma (Pty) Aventis Pharma (Pty) Aventis Pharma (Pty) Aventis 6 Government Gazette 16 December 2005 No. 3556 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/10.2.2/0044 05/7.1.3/0045 05/7.1/0046 05/21.2/0047 05/30.1/0048 05/30.1/0049 05/30.1/0050 REG. NO. NAMIBIA 05/30.1/0040 05/30.1/0041 05/30.1/0042 05/30.1/0043

Each Tablet contains Perindopril 2 mg , Indapamide 0,625 mg contains Perindopril Tablet Each 2,5 mg contains Indapamide Tablet Each 80 mg contains Gliclazide Tablet Each Each immunising dose(0,5ml) solution of Influenza Vaccine contains; Vaccine solution of Influenza Each immunising dose(0,5ml) A/New strain 15 µg hemagglutinin, A/Moscow/10/99 (H N )-like Haeophillus contains: dose(0,5ml) immunising each reconstitution, After Montelukast Sodium equal to the molar contains Tablet Each Chewable recombinant Antigen DNA Each 0,5 ml suspension contains Hepatitis B recombinant Antigen DNA Each 1,0 ml suspension contains Hepatitis B vaccine 10,0 µg vaccine 20,0 µg STRENGTH/DOSE UNIT strain 15 µg hemagglutinin, caldonia/20/99 (H N )-like µg hemagglutinin B/Hongkong/330/2001 15 (),5ml) contains at least 1000 mouse LD50 Each immunisation dose virus strain 17D/AB 237 live attenuated yellow fever (),5ml) contains at least 1000 mouse LD50 Each immunisation dose 238 live attenuated yellow fever virus strain 17D/AB equivalent of Montelukast free acid 4,0 mg device contain PPD Each sterile, single dose, disposable multipuncture 0,025µg (5IU) Tuberkulin Toxoid ≥ 30 IU, Tetanus Toxoid ≥ 40 IU Toxoid Tetanus ≥ 30 IU, Toxoid Influenzae type B capsular polysaccharide conjugated to 20 µg Tetanus Tetanus to 20 µg Influenzae type B capsular polysaccharide conjugated 10 µg, Filamentous Haemogglutinin 5 Toxoid protein 10 µg, Pertusis Diptheria µg, 3 protein) kDa (69 Pertactin µg, 5 2+3) (AGG Fimbriae µg, Lyophilised Lyophilised Lyophilised Tablets Tablets Tablets Puncture Device Suspension for Injection Suspension for Injection DOSSAGE FORM Solution for Injection Powder for Injection Powder for Injection Powder + Solution Chewable Tablet Multipple Purified Protein Derivative Tuberkulin, Antigen DNA Hepatitis B Antigen DNA Hepatitis B APPROVED NAME OF APPROVED NAME OF Vaccine Influenza Perindopril , Indapamide Indapamide Gliclazide recombinant vaccine recombinant vaccine Live attenuated yellow fever virus Live attenuated yellow fever strain 17D/AB 237 virus Live attenuated yellow fever strain 17D/AB 238 Hemophylus type b conjugate vaccine reconstituted with acellular Component Pertussis combined with Diptheria Vaccine adsorbed. Toxoids and tetanus Montelukast Sodium ACTIVE(S) Biocine Test PPD Test Biocine Preterax Catexan Diaglucide (Multi-Puncture Device) Heberbiovac HB 10 µg /0,5 ml Heberbiovac HB 20 µg /1,0 ml Stamaril Single Dose Stamaril Multidose Dose Actacel Singulair 4 mg REGISTERED NAME Mutagrip Biovac S.A. (Pty) Ltd Biovac S.A. (Pty) Ltd Ltd Biovac S.A. (Pty) Ltd Ltd Servier Laboratories Africa (Pty) Ltd South MSD (Pty) Ltd Limited Limited Limited Limited APPLICANT Biogaran South Africa Biogaran South Africa Biogaran South Aventis Pharma (Pty) Pharma (Pty) Aventis Pharma (Pty) Aventis Pharma (Pty) Aventis Aventis Pharma (Pty) Pharma (Pty) Aventis No. 3556 Government Gazette 16 December 2005 7 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/34/0056 05/18.1/0057 05/20.1.1/0058 05/20.1.1/0059 05/20.1.1/0060 05/2.7/0061 05/2.7/0062 05/5.1/0063 05/4/0064 REG. NO. NAMIBIA 05/30.1/0051 05/5.3/0052 05/2.9/0053 05/2.9/0054 05/7.1.4/0055 Each 5,0 ml suspension contains Hepatitis B Antigen DNA recombinant Antigen DNA contains Hepatitis B Each 5,0 ml suspension Hydrochloride Injection 5mg/2ml Verapamil for Injections 1 ml Water Each 1 ml solution contains to Ampoule contains Gentamycin Sulphate equiv. Each 2,0 ml to Ampoule contains Gentamycin Sulphate equiv. Each 1,0 ml to Ampoule contains Gentamycin Sulphate equiv. Each 2,0 ml to 1,80 mg equiv. Each 1 ml liquid contains Epinephrine Bitartrate Each 1,0 ml solution contains Morphine Sulphate 15,0 mg Each 1,0 ml solution contains Morphine Sulphate Epinephrine 1,0 mg 50 mg Each 10 ml solution contains Bupivacaine Hydrochloride STRENGTH/DOSE UNIT vaccine 100,0 µg Neostigmine Sulphate 2,5 mg Each ml of Injection contains Injection 50 mg/ml Pethidine Hydrochloride Injection 100 mg/2ml Pethidine Hydrochloride Each 2,0ml ampoule contains Furosemide 20,0mg Gentamycin Base 20,0 mg Gentamycin Base 40,0 mg Gentamycin Base 80,0 mg 10,0 mg Each 1,0 ml solution contains Morphine Sulphate Injection Injection Injection DOSSAGE FORM Suspension for Injection Injection Injection Injection Injection Injection Injection Injection Injection Injection Injection - Verapamil Hydrochloride Verapamil for Injections Water APPROVED NAME OF APPROVED NAME OF recom Antigen DNA Hepatitis B Gentamycin Sulphate Gentamycin Sulphate Morphine Sulphate Morphine Sulphate Epinephrine Bitartrate Bupivacaine Hydrochloride Pethidine Hydrochloride Pethidine Hydrochloride Pethidine Hydrochloride Furosemide Injection Gentamycin Sulphate ACTIVE(S) binant vaccine Neostigmine Sulphate Micro Adrenaline Micro Micro Verapamil Verapamil Micro for Water Micro Micro Gentamicin Injection 40mg/1ml Micro Gentamicin Injection 80mg/1ml Micro Morphine Injection 10 mg Micro Morphine Injection 15 mg Injection 1mg/1ml Micro Bupivacaine Injection 50mg/10 ml Micro Pethidine Injection 50mg/1ml Micro Pethidine Injection 100mg/2ml Injection 5mg/2ml Injections Micro Furosemide Injection 20mg/2ml Micro Gentamicin Injection 20mg/2ml REGISTERED NAME Heberbiovac HB 100 µg /5,0 ml Micro Neostigmine Methyl Sulphate A/A Injection 2,5 mg/ml Micro Healthcare (Pty) Ltd Ltd Micro Healthcare (Pty) Ltd Micro Healthcare (Pty) Ltd Micro Healthcare (Pty) Ltd Micro Healthcare (Pty) Ltd Micro Healthcare (Pty) Ltd Micro Healthcare (Pty) Ltd Micro Healthcare (Pty) Ltd Micro Healthcare (Pty) Ltd Micro Healthcare (Pty) Ltd Micro Healthcare (Pty) Ltd Ltd Micro Healthcare (Pty) Biovac S.A. (Pty) Ltd Micro Healthcare (Pty) APPLICANT 8 Government Gazette 16 December 2005 No. 3556 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/11.4.3/0073 05/11.4.3/0074 05/11.4.3/0075 05/11.4.3/0076 05/11.4.3/0077 05/21.12/0070 05/21.5.1/0071 05/21.5.1/0072 05/4/0078 REG. NO. NAMIBIA 05/20.1.1/0065 05/21.5.1/0066 05/3.1/0067 05/6.1/0068 05/21.12/0069 Each tablet contains Anastrozole 1 mg Each tablet contains Each Tablet contains Bicalutamide 50 mg contains Bicalutamide Tablet Each 40,0 mg contains Esomeprazole Tablet Each 20,0 mg contains Esomeprazole Tablet Each 10 to Omeprazole Magnesium equiv. contains Omeprazole Tablet Each 20 to Omeprazole Magnesium equiv. contains Omeprazole Tablet Each Each vial contains Omeprazole Sodium 42,6 mg equiv. to Omeprazole equiv. Each vial contains Omeprazole Sodium 42,6 mg mg 40 mg Monohydrate Each 1 ml solution contains Ropivacaine Hydrochloride Hydrochloride 2,0 mg to Ropivacaine equiv. STRENGTH/DOSE UNIT Clindamycin Phosphate equiv to Each 4,0 ml solution contains Clindamycin 600,0 mg Beclomethasone Dipropionate 50 µg Each metered spray contains Diclofenac Sodium 75,0 mg Each 3,0 ml solution contains Hydrochloride 200 mg Each 5ml contains Dopamine Formoterol Fumarate Each delivered dose contains Budesonide 80mcg, Dihydrate 4,5 mcg Formoterol Fumarate Each delivered dose contains Budesonide 160mcg, Dihydrate 4,5 mcg mg Tablets Tablets Tablets Tablets Tablets Tablets Dry Powder for Infusion Infusion DOSSAGE FORM Injection Nasal Spray Injection Injection Inhaler Inhaler Anastrozole APPROVED NAME OF APPROVED NAME OF Esomeprazole Esomeprazole Omeprazole Magnesium Omeprazole Magnesium Omeprazole Sodium Ropivacaine Hydrochloride Monohydrate Diclofenac Sodium Dopamine Hydrochloride Bicalutamide Budesonide , Formoterol Fumarate Dihydrate Budesonide , Formoterol Fumarate Dihydrate ACTIVE(S) Clindamycin Phosphate Beclomethasone Dipropionate Symbicord Turbuhaler Turbuhaler Symbicord Turbuhaler Symbicord Viarox Aqueous Viarox Nexiam 40 mg Nexiam 20 mg Losec Mups 10 Losec Mups 20 Losec Inf 40 Naropin 2 mg/ml Polybag Micro Diclofenac Injection 75mg/3 ml Micro Dopamine Concentrate Injection 200mg/5ml Casodex 50 Arimidex 1 mg 80:4,5 mcg/dose 160:4,5 mcg/dose REGISTERED NAME Micro Clindamycin Injection 600 mg/4ml ------AstraZeneca Pharma ceuticals (Pty) Ltd ceuticals (Pty) Ltd AstraZeneca Pharma ceuticals (Pty) Ltd AstraZeneca Pharma ceuticals (Pty) Ltd AstraZeneca Pharma ceuticals (Pty) Ltd AstraZeneca Pharma ceuticals (Pty) Ltd AstraZeneca Pharma ceuticals (Pty) Ltd AstraZeneca Pharma ceuticals (Pty) Ltd AstraZeneca Pharma ceuticals (Pty) Ltd AstraZeneca Pharma ceuticals (Pty) Ltd AstraZeneca Pharma Micro Healthcare (Pty) Ltd Ltd Micro Healthcare (Pty) Ltd Micro Healthcare (Pty) Ltd Schering-Plough (Pty) APPLICANT No. 3556 Government Gazette 16 December 2005 9 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/11.9/0091 05/2.7/0084 05/3.1/0085 05/2.7/0086 05/3.1/0087 05/21.2/0088 05/21.2/0089 05/7.1/0090 05/21.2/0092 05/20.1.1/0093 REG. NO. NAMIBIA 05/4/0079 05/4/0080 05/7.1.3/0081 05/7.1.3/0082 05/14.4.1/0083 Each Tablet contains Candesartan Cilexetil 16 mg Tablet Each Hydrochlorthiazide contains Candesartan Cilexetil 16,0 mg, Tablet Each 500 mg contains Paracetamol Tablet Each 200 mg contains Ibuprofen Tablet Each 500 mg Each film coated tablet contains Metformin Hydrochloride 850 mg Each film coated tablet contains Metformin Hydrochloride 2,5 mg contains Indapamide Tablet Each 80 mg contains Gliclazide Tablet Each Each Ampoule contains Gentamycin Sulphate equiv. to Gentamycin Ampoule contains Gentamycin Sulphate equiv. Each Each Capsule contains Loperamide hydrochloride 2 mg Each Capsule contains Loperamide hydrochloride base 80 mg STRENGTH/DOSE UNIT Ropivacaine Hydrochloride Monohydrate Each 1 ml solution contains 7,5 mg to Ropivacaine Hydrochloride equiv. Ropivacaine Hydrochloride Monohydrate Each 1 ml solution contains 10,0 mg to Ropivacaine Hydrochloride equiv. 12,5 mg 1 mg Each 1 gram lotion contains Mometasone Furoate Each Capsule contains Indomethacin 25 mg Each 5 ml Syrup contains Paracetamol 120 mg Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Capsules Injection DOSSAGE FORM Injection Injection Lotion Capsules Syrup APPROVED NAME OF APPROVED NAME OF Ibuprofen Metformin Hydrochloride Metformin Hydrochloride Indapamide Loperamide hydrochloride Gliclazide Gentamycin Sulphate Candesartan Cilexetil Candesartan Cilexetil, Hydrochlorthiazide Mometasone Furoate Paracetamol Indomethacin Paracetamol ACTIVE(S) Ropivacaine Hydrochloride Monohydrate Ropivacaine Hydrochloride Monohydrate Entalgic Tablets Entalgic Dynofen Rolab Metformin HCl Tablets 500 Rolab-Metformin HCl Tablets 850 Rolab-Indapamide 2,5 Tablet Rolab-Loperamide HCl 2 mg Rolab-Gliclazide 80 Rolab-Gentamicin 80 mg/2ml Atacand 16 mg Atacand Plus Elocon Lotion Famethacin Entalgic Syrup REGISTERED NAME Naropin 7,5 mg/ml Polyamp Naropin 10 mg/ml Polyamp - - - - Rolab (Pty) Ltd Rolab (Pty) Ltd Rolab (Pty) Ltd Rolab (Pty) Ltd Rolab (Pty) Ltd Rolab (Pty) Ltd Ltd Aquila Healthcare (Pty) Ltd Aquila Healthcare (Pty) Ltd Aquila Healthcare (Pty) Ltd Aquila Healthcare (Pty) Ltd AstraZeneca Pharma ceuticals (Pty) Ltd Schering-Plough (Pty) ceuticals (Pty) Ltd AstraZeneca Pharma ceuticals (Pty) Ltd AstraZeneca Pharma ceuticals (Pty) Ltd AstraZeneca Pharma APPLICANT 10 Government Gazette 16 December 2005 No. 3556 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/30.2/0101 05/20.1.1/0102 05/20.1.1/0103 05/26/0104 05/34/0105 05/34/0106 05/26/0107 05/34/0108 REG. NO. NAMIBIA 05/10.2/0094 05/10.2/0095 05/2.2/0096 05/3.1/0097 05/5.7.2/0098 05/5.7.2/0099 05/30.2/0100 Each Tablet contains Leflunomide 10 mg contains Leflunomide Tablet Each Each sustained release tablet contains Theophylline anhydrous 300 mg Theophylline anhydrous contains Each sustained release tablet 200 mg Theophylline anhydrous contains Each sustained release tablet contains Flunitrazepam 1 mg Tablet Each contains Dolasetron Mesilate 50 mg Tablet Each Each 5ml vial contains Anti-human Thymocyte Equine Immunoglobulin Anti-human Each 5ml vial contains 200,0 mg Teicoplanin to Sodium equiv. Teicoplanin Each vial contains 400,0 mg Teicoplanin to Sodium equiv. Teicoplanin Each vial contains to equiv. Trihydrate Each single dose vial (2ml) contains Docetaxel Alfa 2-b 3 million IU; Each Each 0,2 solution contains Interferon Amifostine 500 mg. equiv to Trihydrate Amifostine Each vial contains Alfa -2b 3 million IU Each 0,2 ml Solution contains Interferon Each vial contains Rabbit Antihuman Thymocyte Immunoglobulin Antihuman Each vial contains Rabbit Each 1,0 ml of concentrate contains Doxorubicin Hydrochloride 2,0 mg Each 1,0 ml of concentrate contains Doxorubicin STRENGTH/DOSE UNIT Mesilate 12,5 mg in 0,625 ml Each ampoule contains Dolasetron solution for injection 25,0mg 100,0mg 80 Docetaxel (Anhydrous) 80,0mg in 2ml Polysorbate Capsule contains Ribavirin 200,0 mg Tablets Tablets Lyophilised Tablets Tablets Tablets Powder for Injection Concentrate for Infusion Multidose Injection Pen DOSSAGE FORM Injection Powder for Injection Injection Injection Injection Injection Combination of dosdages Anti-human Thymocyte Equine Anti-human Leflunomide Teicoplanin Sodium Teicoplanin Trihydrate Docetaxel Alfa 2-b Ribavirin Interferon Trihydrate Amifostine Alfa -2b Interferon Rabbit Antihuman Thymocyte Antihuman Rabbit Sodium Teicoplanin APPROVED NAME OF APPROVED NAME OF Doxorubicin Hydrochloride Dolasetron Mesilate Dolasetron Mesilate Immunoglobulin Immunoglobulin ACTIVE(S) Theophylline anhydrous Theophylline anhydrous Flunitrazepam Intron A (HAS-Free) A Intron Zamanon 50 mg Tablets Zamanon 50 mg Lymphoglobuline 200 Injection + Targocid 400 Injection + Targocid 80mg + Taxotere Arava 10 mg Tablets Arava 10 mg Diluent Diluent Rebetron Ethyol Caelyx Redipen 3 million IU Zamanon 12,5 mg IV Thymoglobuline Diluent REGISTERED NAME Rolab-Theophylline 300 Rolab-Theophylline 200 Rolab-Flunitrazepam 1 Ltd Schering-Plough (Pty) Ltd Schering-Plough (Pty) Ltd Schering-Plough (Pty) Ltd Limited Schering-Plough (Pty) Limited Limited Limited Limited Limited Limited Rolab (Pty) Ltd Limited Rolab (Pty) Ltd Rolab (Pty) Ltd APPLICANT Aventis Pharma (Pty) Aventis Pharma (Pty) Aventis Pharma (Pty) Aventis Aventis Pharma (Pty) Pharma (Pty) Aventis Pharma (Pty) Aventis Pharma (Pty) Aventis Pharma (Pty) Aventis Pharma (Pty) Aventis No. 3556 Government Gazette 16 December 2005 11 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/7.1/0115 05/7.1/0116 05/5.7.2/0119 05/30.4/0113 05/20.2.8/0114 05/13.9/0110 05/30.2/0111 05/30.4/0112 05/11.4.3/0117 05/20.2.2/0118 05/20.2.2/0120 05/7.1/0121 05/5.8/0122 05/10.2.2/0123 05/7.1/0124 05/7.1/0125 REG. NO. NAMIBIA 05/34/0109 Captopril Tablet 25 mg Tablet Captopril 50 mg Tablet Captopril 50 mg Tablet Cyclizine Hydrochloride Mesylate equivalent to Doxazosin 4 mg contains Doxazosin Tablet Each Mesylate equivalent to Doxazosin 1 mg contains Doxazosin Tablet Each Mesylate equivalent to Doxazosin 2 mg contains Doxazosin Tablet Each Each 0,2 ml Solution contains Interferon Alfa -2b 5 million IU Interferon Each 0,2 ml Solution contains Acid Mometasone Furoate 1,0 mg, Salicylic Each 1g Ointment contains Activity VIII Inhibitor Bypassing Factor Each 1 ml solution contains: with Vials Powder in Glass Lyophilized Antithrombin III Concentrate 30,0 g Each Infusion Bag contains Haemoglobin Glutamer-250 Acyclovir 0,05 g Each 1 g cream contains Hydrochloride 0,625 mg, Triprolidine Each 5 ml Syrup contains: Ketotifen base Each 5 ml Syrup contains Ketotifen Fumarate equiv.to Pseudoephedrine Hydrochloride 15,0 mg, Paracetamol 125,0 mg Pseudoephedrine Hydrochloride 15,0 mg, Paracetamol 1,0 mg STRENGTH/DOSE UNIT 50,0 mg 50 IU Solvent 50 IU/ml Each tablet contains Cimetidine 400 mg Each 5 g cream contains Clotrimazole 50 mg mg Each 1 ml of Shampoo contains Ketoconazole 20 Tablets Tablets Tablets Tablets Tablets Tablets Tablets Syrup DOSSAGE FORM Multidose Injection Pen Ointment Injection Injection Infusion Cream Cream Shampoo Syrup Factor VIII Inhibitor Factor Haemoglobin Glutamer-250 Haemoglobin Glutamer-250 Acyclovir APPROVED NAME OF APPROVED NAME OF Alfa -2b Interferon Clotrimazole Cyclizine Hydrochloride Ketoconazole Doxazosin Mesylate Combination Ketotifen Fumarate Doxazosin Mesylate Doxazosin Mesylate Antithrombin III Concentrate Antithrombin III Concentrate Captopril Captopril Cimetidine ACTIVE(S) Mometasone Furoate, Salicylic Acid Adco-Acyclovir Topical Topical Adco-Acyclovir Alcohol Adco-Ketotifen Intron A (HAS-Free) A Intron 4 Imuno 500 Tim Feiba Adco-Clotrimazole Cream Topical Adco-Cyclizine 50 mg Adco-Dermed Adco-Doxazosin 4 Adco-Flupain and Sugar Free Adco-Doxazosin 1 Adco-Doxazosin 2 Antithrombin III Imuno Antithrombin III Imuno 1000 IU Hemopure Cream Adco-Captopril 25 mg Adco-Captopril 50 mg Adco-Cimetidine 400 mg REGISTERED NAME Redipen 5 million IU Elosalic Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited (Pty) Ltd Adcock Ingram Limited Adcock Ingram Critical Care (Pty) Ltd Ltd Adcock Ingram Critical Care (Pty) Ltd Schering-Plough (Pty) Ltd Schering-Plough (Pty) APPLICANT Tshepo Pharmaceuticals Tshepo 12 Government Gazette 16 December 2005 No. 3556 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/11.9/0139 05/7.5/0132 05/18.3/0133 05/5.8/0134 05/5.8/0135 05/3.1/0136 05/2.2/0137 05/2.2/0138 04/18.1/0140 05/16.3/0141 REG. NO. NAMIBIA 05/7.1.3/0126 05/1.2/0127 05/1.2/0128 05/1.2/0129 05/7.5/0130 05/7.5/0131 Each Tablet contains Atenolol 100 mg, Chlorthalidone 25 mg Atenolol 100 contains Tablet Each contains Moclobemide 150 mg Tablet Each contains Moclobemide 300 mg Tablet Each to Paroxetene Base 20 contains Paroxetene Mesylate equiv. Tablet Each contains Simvastatin 10 mg Tablet Each 20 mg contains Simvastatin Tablet Each 40 mg contains Simvastatin Tablet Each Hydrochloride 60 mg. contains Pseudoephedrine Tablet Each 200 mg contains Sulindac Tablet Each Hemitatrate 5 mg contains Zolpidem Tablet Each Hemitatrate 10 mg contains Zolpidem Tablet Each HCl 2 mg contains Loperamide Tablet Each 1 mg contains Bumetanide Tablet Each Each Lozonge contains: Cetylpyridinium Chloride 1,40 mg, Benzocaine Each Lozonge contains: Cetylpyridinium Chloride 10,00 mg STRENGTH/DOSE UNIT mg Bicarbonate 1,716 g, Each 4g contains: Sodium Citrate 0,613 g, Sodium Acid 0,858 g Tartaric Anhydrous 0,702 g, Acid Citric 30 mg Each 5 ml Syrup contains Pseudoephedrine Hydrochloride Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Lozenge DOSSAGE FORM Sachet Syrup APPROVED NAME OF APPROVED NAME OF Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride Sulindac Zolpidem Hemitatrate Zolpidem Hemitatrate Loperamide HCl Bumetanide 1 Cetylpyridinium Chloride Benzocaine Paroxetene Mesylate Simvastatin Simvastatin Simvastatin Sodium Citrate Sodium Acid Bicarbonate Citric Acid Tartaric Anhydrous, ACTIVE(S) Atenolol , Chlorthalidone Moclobemide Moclobemide - - Cepacaine Anaesthetic Cepacaine Adco-Sufedrin Tablets Adco-Sufedrin Tablets Betaperamide Adco-Sufedrin Syrup Adco-Sulindac 200 mg Adco-Zolpidem Hemi tatrate 5 mg Adco-Zolpidem Hemi tatrate 10 mg Burinex 1 mg Lozenges Blackcurrant Flavour 300 mg Adco-Paroxetine 20 mg Adco-Simvastatin 10 mg Adco-Simvastatin 20 mg Adco-Simvastatin 40 mg Adco-Sodasol REGISTERED NAME Adco-Loten Adco-Moclobemide 150 mg Adco-Moclobemide Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited APPLICANT No. 3556 Government Gazette 16 December 2005 13 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/2.8/0146 05/13.9.1/0147 05/13.9.1/0148 05/13.5/0149 05/21.8.1/0150 05/21.8.1/0151 05/8.3/0152 05/5.8/0153 05/15.4/0154 05/15.4/0155 REG. NO. NAMIBIA 05/16.3/0142 05/16.3/0143 05/16.4/0144 05/5.8/0145 Each Tablet contains Oestradiol Valerate 1 mg Valerate contains Oestradiol Tablet Each Acid 500 mg, Ascorbic Sulphate 525 mg, contains: Ferrous Tablet Each Acid 350 µg Folic Each Effervescent Tablet contains: Paracetamol 650 mg, Phenylephrine Tablet Each Effervescent C 250 mg Vitamin HCl 10 mg, contain 1 mg, 12 tablets Valerate contain Oestradiol Tablets 16 Each Polypapaper Sachet contains: Aspirin 453,6 mg, Paracetamol 324,0 Paracetamol mg, 453,6 Aspirin contains: Sachet Polypapaper Each 64,8 mg mg caffeine to Calcipotriol 50 Each 1 g Cream contains Calcipotriol Hydrate equiv. to Hydrate equiv. Each 1 ml of Scalp Solution contains Calcipotriol 50,0mg, Caffeine Each 5 g Sachet contains: Paracetamol 800,0mg, Acid 10,0mg Ascorbic Each 1 ml solution contains Polyvidone 50 mg preservative) Each 1 ml solution contains Polyvidone 50 mg (no STRENGTH/DOSE UNIT Cetylpyridinium Chloride 1,40 mg, Benzocaine Each Lozonge contains: 10,00 mg Chloride 1,47 mg, Benzyl Each lozenge contains: Cetylpyridinium Alcohol 6,5 mg Chloride 1,47 mg, Benzyl Each lozenge contains: Cetylpyridinium Alcohol 6,5 mg µg Calcipotriol 50 µg Castor Oil 5 g Each 10 g Cream contains: Zinc Oxide 750 mg, Oestradiol valerate 2 mg, Norethisterone 1 mg Tablets Tablets Tablets Tablets Powder Solution Solution DOSSAGE FORM Lozenge Lozenge Lozenge Powder Cream Solution Cream Oestradiol Valerate Valerate Oestradiol Valerate, Oestradiol Acid Ascorbic Ferrous Sulphate , Acid , Folic Ascorbic , Paracetamol , Caffeine Aspirin, Paracetamol , Caffeine to Calcipotriol Hydrate equiv. to Calcipotriol Hydrate equiv. APPROVED NAME OF APPROVED NAME OF Zinc Oxide, Castor Oil Norethisterone Acid Polyvidone Polyvidone Cetylpyridinium Chloride, Cetylpyridinium Chloride, Alcohol Benzyl Paracetamol , Phenylephrine HCl, C Vitamin Calcipotriol Calcipotriol ACTIVE(S) Cetylpyridinium Chloride, Benzocaine Cetylpyridinium Chloride, Alcohol Benzyl Colcaps C Effervescent Colcaps C Effervescent Babby Anne’s Elizabeth Cepacaine Anaesthetic Cepacaine Throat Cepacol Throat Cepacol Nappy Rash Cream Estro-Pause 1 mg Estro-Pause N Fero-Folic Grippon Hot Relief Ginger Hypotears Plus Hypotears Plus SDU Lozenges Blackcurranrt Lozenges Blackcurranrt Flavour Lozenges Honey and Lemon Flavour Compral Headache Powders Devonex Cream Devonex Scalp Solution REGISTERED NAME Lozenges Honey and Lemon Flavour Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited APPLICANT 14 Government Gazette 16 December 2005 No. 3556 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/11.9/0161 05/11.4.1/0160 05/12/0162 05/12/0163 04/10.1/0164 05/2.8/0165 05/13.6/0166 05/10.2/0167 05/22.1.1/0168 05/15.4/0169 05/16.3/0170 REG. NO. NAMIBIA 05/13.3/0156 05/16.3/0157 05/2.8/0158 05/2.7/0159 Each Tablet contains Theophylline Anhydrous 600 mg Anhydrous Theophylline contains Tablet Each Each Tablet contains Loperamide HCl 2 mg contains Loperamide Tablet Each 100 mg contains Mebendazole Tablet Each Each 1,0 g Gel contains Timolol Maleate equiv. to Timolol Base 1,0 mg Timolol to Maleate equiv. Timolol Each 1,0 g Gel contains to Aluminium Hydroxide equiv. contains: Each 10 ml of suspension with Minerals Syrup Vitamins combination A Each Single Dose Unit 0,3ml contain Diclofenac sodium 0.3 mg Each Single Dose Unit 0,3ml contain Diclofenac 1,50 mg, Benzocaine Each Lozonge contains: Cetylpyridinium Chloride 12,00 mg STRENGTH/DOSE UNIT Eucalyptus Oil 5,03 g, Racemic Each 100 g Ointment contains: Thyme Oil 0,50 g Camphor 1,81 g, Dibucaine HCl 5 mg, Benzocaine Each 15 ml of Solution contains: 60 mg, Alcohol Chloride 3,713 mg, Benzyl 30 mg, Cetylpyridinium Alcohol 15,3% v/v. Paracetamol 60 mg Each 0,6 ml of Syrup contains mg, Aluminium Oxide 200 mg, Magnesium Oxide 200 Methylpolysiloxane 50 mg mg Each 5 ml Suspension contains Mebendazole 100 Each 10 ml of Syrup contains Guaifenesin 200 mg mg, Paracetamol 450 Each Capsule contains Doxylamine Succinate 5 Anhydrous 30 mg. mg, Codeine Phosphate 10 mg, Caffeine 10 g Each 100 g Ointment contains Methyl Salycylate Tablets Tablets Tablets Syrup Eye Drops Lozonge DOSSAGE FORM Ointment Solution Gel Syrup Suspension Suspension Syrup Capsules Ointment - A combination Vitamins with Vitamins combination A Theophylline Anhydrous Theophylline Timolol Maleate Timolol contains Loperamide Tablet Each APPROVED NAME OF APPROVED NAME OF Doxylamine Succinate Paracetamol , Codeine Phosphate, Anhydrous . Caffeine Methyl Salycylate Minerals Syrup Diclofenac sodium Benzocaine, Cetylpyridinium chloride Paracetamol Aluminium Hydroxide Magne sium Oxide Methylpolysiloxane HCl 2 mg Mebendazole Mebendazole Guaifenesin ACTIVE(S) Eucalyptus Oil , Racemic Thyme Oil Camphor, Dibucaine HCl Benzocaine, , Cetylpyridinium Chloride v/v. 15,3% Alcohol , Alcohol Benzyl Voltaren Optha SDU Voltaren Honey and A Medi-Keel Throat Lozonges Lemon Rioworm Tablets Rioworm with Minerals Vi-daylin Medicated Ingram’s Medicated Ingram’s Throat Medi Keel a Gargle Peppermint Flavour Syndol Thermo-Rub Uniphyl 600 Nyogel Panado Infant Drops Pedimed Paediatric Suspension Prodium Rioworm Suspension Stearns Guaiphenesin Cough Syrup REGISTERED NAME Herbal Ointment Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited APPLICANT No. 3556 Government Gazette 16 December 2005 15 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/20.2.6/0177 05/20.2.6/0178 05/20.2.6/0179 05/20.2.6/0180 05/5.7.1/0181 05/20.1.1/0182 05/20.1.1/0183 05/7.1.3/0184 REG. NO. NAMIBIA 05/16.3/0171 05/2.8/0172 05/10.1/0173 05/2.8/0175 05/13.1/0176 Each Tablet contains: Paracetamol 320 mg, Codeine Phosphate 8 mg, contains: Paracetamol 320 mg, Codeine Tablet Each 32 mg, Meprobamate 150 mg Anhydrous Caffeine Citrate 35 mg contains Paracetamol 450 mg, Orphenadrine Tablet Each 10 mg contains Loratadine Tablet Each Each 5 ml Syrup contains: Triprolidine HCl 1,25 mg, Codeine HCl 1,25 mg, Codeine Triprolidine Each 5 ml Syrup contains: to 5 mg equiv. Each 1 g Cream contains Povidone Iodine 50 mg, to Chloroquine equiv. Each 5 ml Syrup contains Chloroquine Sulphate to Ceftriaxone 2,0 g Each vial contains Ceftriaxone Sodium equiv. to Ceftriaxone 1,0 g Each vial contains Ceftriaxone Sodium equiv. Each tablet contains Perindopril 4,0mg STRENGTH/DOSE UNIT Cetylpyridinium Chloride 1,50 mg, Benzocaine Each Lozonge contains: 12,00 mg HCl 30 mg Phosphate 10 mg, Pseudoephedrine available Iodine base 50 mg Each 1 ml of Solution contains Fluconazole 2,0mg Each Capsule contains Fluconazole 200,0 mg Each Capsule contains Fluconazole 150,0 mg Tablets Tablets Tablets Tablets Dry Powder for Injection DOSSAGE FORM Lozonge Syrup Cream Syrup Solution for Infusion Capsules Capsules Dry Powder for Injection Triprolidine HCl , Codeine HCl , Codeine Triprolidine APPROVED NAME OF APPROVED NAME OF Fluconazole Loratidine Ceftriaxone Sodium Ceftriaxone Sodium Perindopril Meprobamate HCl Phosphate, Pseudoephedrine Paracetamol , Orphenadrine Citrate Povidone Iodine Chloroquine Sulphate Fluconazole Fluconazole ACTIVE(S) Benzocaine, Cetylpyridinium chloride Paracetamol , Codeine Anhydrous, Phosphate, Caffeine

Betadine First Aid Betadine First Tablet Lorano 10 mg Medi-Keel A Blackcurrant A Medi-Keel Adco-Tussend Tablets Besemax Fluzol 150 mg Capsules Rociject 2,0g Injection Rociject 1,0g Injection Prexum Cream Mirquin Syrup Fluzol 2 mg/1ml Solution Fluzol 200 mg Capsules REGISTERED NAME Throat Lozonges Adco-Pyne (Pty) Ltd Generix International (Pty) Ltd SA Generix International (Pty) Ltd SA (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd Hexal Pharma (SA) Hexal Pharma (SA) (Pty) Ltd Adcock Ingram Limited Oshakati Pharmacy Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited APPLICANT Biogaran South Africa Biogaran South 16 Government Gazette 16 December 2005 No. 3556 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/20.1.1/0191 05/20.1.1/0192 05/7.1.3/0193 05/7.1.3/0194 05/7.1.3/0195 05/20.1.2/0196 05/20.1.2/0197 05/1.2/0198 05/21.1/0199 05/3.1/0200 05/15.4/0201 REG. NO. NAMIBIA 05/1.2/0185 05/20.1.1/0186 05/20.1.1/0187 05/20.1.1/0188 05/18.1/0189 05/20.1.1/0190 Each Tablet contains Cefuroxime Axetil equiv. to Cefuroxime 125,0 mg Axetil equiv. contains Cefuroxime Tablet Each to Cefuroxime 250,0 mg Axetil equiv. contains Cefuroxime Tablet Each to Cefuroxime 500,0 mg Axetil equiv. contains Cefuroxime Tablet Each Each Tablet contains Triamterene 50 mg, Hydrochlorothiazide 25 mg Triamterene contains Tablet Each Each Tablet contains Minocycline Hydrochloride equiv. to Minocycline contains Minocycline Hydrochloride equiv. Tablet Each to Minocycline contains Minocycline Hydrochloride equiv. Tablet Each 5,0 mg contains Lisinopril Tablet Each 10,0 mg contains Lisinopril Tablet Each 20,0 mg contains Lisinopril Tablet Each Each Capsule contains Fluoxetine Hydrochloride equiv. to Fluoxetine to Fluoxetine Hydrochloride equiv. Each Capsule contains Fluoxetine to equiv. Trihydrate Amoxycillin Each 5 ml Suspension contains to equiv. Trihydrate Amoxycillin Each 5 ml Suspension contains to Fluoxetine equiv. Each Capsule contains Fluoxetine Hydrochloride Aspart 100,0 Units Each 1 ml suspension contains Biphasic Insulin Each Capsule contains Piroxicam 20 mg Each 1 ml Solution contains Bimatoprost 0,3 mg STRENGTH/DOSE UNIT 20 mg 100 mg 50 mg 250 mg Each Capsule contains Cephalexin Amoxycillin 125,0 mg Amoxycillin 250,0 mg 20,0 mg Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Capsules Eye Drops DOSSAGE FORM Capsules Capsules Suspension Suspension Capsules Injection Cefuroxime Axetil Cefuroxime Axetil Cefuroxime Axetil Cefuroxime Triamterene, Hydrochlorothiazide Triamterene, Amoxycillin Trihydrate Trihydrate Amoxycillin Trihydrate Amoxycillin Aspart Biphasic Insulin APPROVED NAME OF APPROVED NAME OF Fluoxetine Hydrochloride Piroxicam Bimatoprost Minocycline Hydrochloride Cephalexin Lisinopril Lisinopril Lisinopril ACTIVE(S) Fluoxetine Hydrochloride Minocycline Hydrochloride Ceroxim 125 Tablets Ceroxim 125 Tablets Ceroxim 250 Tablets Ceroxim 500 Tablets Sinopren 5 Tablets Sinopren 10 Tablets Sinopren 20 Ranflocs 20 Capsules Rolab-Triamterene/ 50/25 Hydrochlorothiazide 125 mg/5 ml Ranmoxy Suspension 250 mg/5 ml NovoMix 30 Sandoz Piroxicam 20 Lumigan Rolab-Minocycline 50 Rolab-Cephalexin 250 C Ranmoxy Suspension REGISTERED NAME Rolab-Fluoxetine 20 Rolab-Minocycline 100 - Sandoz (Pty) Limited cals (Pty) Ltd Novo Nordisk (Pty) Limited Ranbaxy (SA) (Pty) Ltd Ranbaxy (SA) (Pty) Ltd Ranbaxy (SA) (Pty) Ltd Ranbaxy (SA) (Pty) Ltd Ranbaxy (SA) (Pty) Ltd Ranbaxy (SA) (Pty) Ltd Ranbaxy (SA) (Pty) Ltd Ranbaxy (SA) (Pty) Ltd Ranbaxy (SA) (Pty) Ltd Rolab (Pty) Ltd Rolab (Pty) Ltd Rolab (Pty) Ltd Rolab (Pty) Ltd Rolab (Pty) Ltd APPLICANT Allergan Pharmaceuti Allergan No. 3556 Government Gazette 16 December 2005 17 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/11.4.3/0207 05/11.5/0211 05/20.2.2/0208 05/5.7/0209 05/2.8/0210 05/2.7/0212 05/30.1/0213 05/30.1/0214 05/30.1/0215 REG. NO. NAMIBIA 05/2.5/0202 05/24/0203 05/20.1.2/0204 05/20.1.2/0205 05/20.1.2/0206 ,8,9 Each Tablet contains Sodium Valproate 100 mg Valproate contains Sodium Tablet Each Each Tablet contains Cimetidine 200 mg contains Cimetidine Tablet Each Each 5 ml Suspension contains Amoxycillin Trihydrate equiv. to equiv. Trihydrate Amoxycillin Each 5 ml Suspension contains to equiv. Trihydrate Amoxycillin Each 5 ml Suspension contains Amoxycillin to equiv. Trihydrate Amoxycillin Each Capsule contains Acid 250 mg Each Capsule contains Mefenamic IU 2 NLT Toxoid Diphtheria Each 0,5ml suspension contains: Purified 20 IU NLT Toxoid Tetanus and Purified capsular polysacharide of streptoccocus Each 0,5 ml contains: Purified 1,2,3,4,5,6B,7F pneumoniae, 25µg, each of the following serotypes: N,10A,11A,12F,14,15B,17F,18C,19A,19F,20,22F,23F,33F STRENGTH/DOSE UNIT Combination Infusion Concentrate Amoxycillin 125 mg Amoxycillin 250 mg 500 mg Each 5 g cream contains Clotrimazole 50 mg 12,5 mg Each 5 ml Syrup contains Cyclizine Hydrochloride Codeine Phosphate 5 Each 5 ml Syrup contains Paracetamol 120 mg, mg, Promethazine Hydrochloride 6,5 mg Each 5 ml Syrup contains Lactulose 3.3 g inactivated Hepatitis Each 0,5ml suspension contains 160 antigen units virus A Tablets Tablets Solution Injection DOSSAGE FORM Injection Dry Powder Dry Powder Capsules Cream Syrup Syrup Syrup Capsules Injection Hepatitis A Vaccine A Hepatitis Mefenamic Acid Mefenamic Toxoid Toxoid,Tetanus Diphtheria Amoxycillin Trihydrate Trihydrate Amoxycillin Trihydrate Amoxycillin Trihydrate Amoxycillin APPROVED NAME OF APPROVED NAME OF Valproate Sodium Lactulose Combination Cimetidine Clotrimazole Cyclizine Hydrochloride Combination ACTIVE(S) Combination Infusion Concentrate Adco-Mefenamic Acid Adco-Mefenamic Avaxim Adco-Liquilax Syrup 250mg Diftavax Imovax Pneumo 23 Adco-Amoxycillin 125mg/5 ml Suspension Adco-Amoxycillin 250mg/5 ml Suspension Adco-Amoxycillin 500 mg Capsules Adco-Cimetidine 200 Tablets mg Adco-Clotrimazole Cream Vaginal Adco-Cyclizine Syrup Adco-Kiddipayne REGISTERED NAME Epilim 100 Crushable Tablets Additrace Limited Limited Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited (Pty) Ltd Adcock Ingram Limited Limited APPLICANT Aventis Pharma (Pty) Aventis Pharma (Pty) Aventis Pharma (Pty) Aventis Fresenius Kabi S.A Fresenius Kabi S.A Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) 18 Government Gazette 16 December 2005 No. 3556 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/20.1.1/0222 05/20.1.1/0223 05/20.1.1/0224 05/20.1.1/0225 05/20.1.1/0226 05/20.1.1/0227 05/20.1.1/0228 05/20.1.1/0229 05/15.4/0230 REG. NO. NAMIBIA 05/30.1/0216 05/30.1/0217 05/7.5/0218 05/7.5/0219 05/7.5/0220 05/20.1.1/0221 Each 0,1ml immunising dose contains Poliomyelitis Virus Type 1 > 1, Type Virus dose contains Poliomyelitis Each 0,1ml immunising 1,000,000 CCID 50, 2 > Type Virus 000,000 CCID 50, Poliomyelitis 3 > 600,000 CCID 50 Type Virus Poliomyelitis A/Moscow/10/99 (H3N2) 15µg contains: Each immunising dose (0,5ml) (H1N1) 15µg hemagglutinin; A/New Caledonia/20/99 hemaglutinin; to Ceftriaxone 1g Each vial contains 1,193g Ceftriaxone Sodium equiv. to Ceftriaxone 2g Each vial contains 2,386g Ceftriaxone Sodium equiv. to Ceftriaxone equiv. Each vial contains 596,5 mg Ceftriaxone Sodium to Cefuroxime 1500 mg Each vial contains Cefuroxime Sodium equiv. to Cefuroxime 1500 mg Each vial contains Cefuroxime Sodium equiv. to Cefuroxime 250 mg Each vial contains Cefuroxime Sodium equiv. to Cefuroxime 750 mg Each vial contains Cefuroxime Sodium equiv. to Ketotifen 0,25 equiv. Each 1 ml solution contains Ketotifen Fumarate mg STRENGTH/DOSE UNIT 15µg hemagglutinin B/Hong Kong/330/2001 10,0mg Each tablet contains Simvastatin 20,0mg Each tablet contains Simvastatin Each tablet contains Simvastatin 40,0mg 500 mg to Cefazolin Each vial contains Cefazolin Sodium 1048 mg equivalent 1000 mg to Cefazolin Each vial contains Cefazolin Sodium 524 mg equivalent 500 mg Tablets Tablets Tablets Powder for Injection Powder for Injection Eye Drops DOSSAGE FORM Suspension Injection Powder for Injection Powder for Injection Powder for Injection Injection Injection Powder for Injection Powder for Injection APPROVED NAME OF APPROVED NAME OF Cefazolin Sodium Cefazolin Sodium Cefazolin Sodium Cefazolin Sodium Cefazolin Sodium Ketotifen Fumarate Simvastatin Simvastatin Simvastatin Ceftriaxone Sodium Ceftriaxone Sodium Ceftriaxone Sodium Cefazolin Sodium ACTIVE(S) Combination Combination OPV-Merieux Vaxigrip Tablets Simvotin 10 Tablets Simvotin 20 Tablets Simvotin 40 Sabax Cefazolin 500 mg Sabax Cefuroxime 1,5 g (20 ml) Sabax Cefuroxime 1,5 g (50 ml) Sabax Cefuroxime 250 mg Sabax Cefuroxime 750 mg Zaditen Eye Drops Adco-Ceftriaxone 1 g Adco-Ceftriaxone 2 g Adco-Ceftriaxone 500 mg Sabax Cefazolin 1 g REGISTERED NAME Adcock Ingram Limited Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Ranbaxy (SA) (Pty) Ltd Ranbaxy (SA) (Pty) Ltd Ranbaxy (SA) (Pty) Ltd Limited Limited APPLICANT Aventis Pharma (Pty) Pharma (Pty) Aventis Aventis Pharma (Pty) Pharma (Pty) Aventis No. 3556 Government Gazette 16 December 2005 19 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/11.5/0246 05/11.5/0245 05/11.4.3/0233 05/11.4.3/0234 05/11.4.3/0235 05/30.1/0238 05/20.1.1/0239 05/20.1.1/0240 05/3.1/0241 05/3.1/0242 05/10.1/0243 05/10.1/0244 REG. NO. NAMIBIA 05/7.1/0231 05/7.1/0232 05/5.7.1/0236 05/20.2.6/0237 Each Tablet contains Yellow Phenopthalein 250 mg Yellow contains Tablet Each Each Tablet contains Loratadine 10 mg Tablet Each to Ranitidine Base contains Ranitidine Hydrochloride equiv. Tablet Each to Ranitidine Base contains Ranitidine Hydrochloride equiv. Tablet Each Atovaquone 250,0mg. Proguanil Hydrochloride Each tablet contains Each 0,5ml dose contains Salmonella Typhi 25,0µg Typhi Each 0,5ml dose contains Salmonella to Ceftriaxone 0,5 g Each vial contains Ceftriaxone Sodium equiv. to Piperacillin equiv. Each single dose vial contains; Piperacillin Sodium 500,0mg Tazobactam to Sodium equiv. Tazobactam 4,0g, Anhydrous Sodium Sulphate 8,5 g in an Each 12.06 g contains base lemon flavoured effervescent STRENGTH/DOSE UNIT Loratidine (micronised) 5 mg Each 5 ml syrup contains 150 mg 300 mg 30 mg Each Capsule contains Lansoprazole 1 mg Each 1 ml syrup contains Cetirizine Dihydrochloride 100,0mg Each tablet contains Meloxicam 15,0mg Each tablet contains Meloxicam 7,5mg Each 10 ml Syrup contains Guaifenesin 200 mg Each 10 ml Syrup contains Guaifenesin 200 mg Tablets Tablets Tablets Tablets Tablets Tablets Tablets Granules DOSSAGE FORM Syrup Capsules Syrup Injection Dry Powder for Injection Injection Syrup Syrup Typhoid Fever Vaccine Fever Typhoid Tazobactam Piperacillin Sodium, Yellow Phenopthalein Phenopthalein Yellow APPROVED NAME OF APPROVED NAME OF Sodium Meloxicam Meloxicam Guaifenesin Guaifenesin Anhydrous Sodium Sulphate Ranitidine Hydrochloride Ranitidine Hydrochloride Lansoprazole Cetirizine Dihydrochloride Atovaquone, Proguanil Hydrochloride Ceftriaxone Sodium ACTIVE(S) Loratidine (micronised) Loratadine Ranitidine Hydrochloride Typherix 4 Injection Tazobax Loxiflam 15 mg Loxiflam 7.5 mg Chief Linctus - Peppermint Flavour Chief Linctus - Cherry Flavour Freshen Fizz Sodium Sulphate Laxative Freshen Phenolphthalein Laxative Adco-Ranitidine 300 Adco-Roznal Adco-Cetirizine Syrup Malanil Rociject 0,5g Injection REGISTERED NAME Adco-Loratadine 5mg/5ml Adco-Loratadine 10 mg Adco-Ranitidine 150 Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Pharmacare Limited Adcock Ingram Limited Generix International (Pty) Ltd SA Pharmacare Limited GlaxoSmithKline South Africa (Pty) Generix International (Pty) Ltd SA Adcock Ingram Limited GlaxoSmithKline South Africa (Pty) Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited APPLICANT 20 Government Gazette 16 December 2005 No. 3556 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/11.5/0253 05/11.4.1/0247 05/11.4.1/0257 05/12/0252 05/18.3/0254 05/2.8/0255 05/24/0256 05/2.6/0258 05/2.6/0259 05/2.6/0260 05/7.1/0261 05/7.1/0262 05/7.1/0263 REG. NO. NAMIBIA 05/2.7/0248 05/20.2.2/0249 05/20.2.2/0250 05/15.1/0251 - Each Tablet contains Alprazolam 0,25 mg contains Tablet Each Alprazolam 0,5 mg contains Tablet Each Alprazolam 1,0 mg contains Tablet Each 25 mg contains Captopril Tablet Each 50 mg contains Captopril Tablet Each 2,5 mg contains Indapamide Tablet Each Each 1,0 ml Solution contains Lomefloxacin Hydrochloride equiv. to Hydrochloride equiv. Each 1,0 ml Solution contains Lomefloxacin Lomefloxacin 3,0 mg Alcohol 60% Aloe Powder 200 mg, Each 5 ml Solution contains Cape mg, 110 Each 5 ml Suspension contains: Magnesium Hydroxide STRENGTH/DOSE UNIT Calcium Carbonate 87 mg, Light Magne Each 5 ml Mixture contains: Sodium Bicarbonate 87 mg, Sodium Citrate 62 sium Carbonate 87 mg, Alcohol 3,739% mg, Paracetamol 120 mg Each 5 ml Syrup contains Clotrimazole 10 mg Each 1 g Cream contains Clotrimazole 10 mg Each 1 g Cream contains Each sachet contains Piperazine Citrate 1,65 g 2,500 g Each 15 ml Mixture contains Potassium Citrate Codeine Phosphate 5 Each 5 ml syrup contains: Paracetamol 120 mg, mg, Promethazine Hydrochloride 6,50 mg 335,8 mg, Sodium Each 30 ml solution contains: Potassium Chloride Dextrose Monohydrate Chloride 473,68 mg, Sodium Citrate 469,8 mg, 3,96 g Magnesium Carbonate Light 250 mg Tablets Tablets Tablets Tablets Tablets Tablets DOSSAGE FORM Mixture Elixir Cream Cream Eye Drops Granules Solution Mixture Syrup Solution Suspension Lomefloxacin Hydrochloride Alcohol 60% Aloe Powder, Cape APPROVED NAME OF APPROVED NAME OF Potassium Chloride, Sodium Chloride, Sodium Citrate, Dextrose Monohydrate Magnesium Hydroxide, Magnesium Carbonate Light Alprazolam Alprazolam Alprazolam Captopril Captopril Indapamide Paracetamol Clotrimazole Clotrimazole Piperazine Citrate Potassium Citrate Paracetamol, Codeine Phosphate, Promethazine Hydrochloride ACTIVE(S) Calcium Carbonate, Light Sodium Magnesium Carbonate , Bicarbonate, Sodium Citrate, Alcohol Dapamax Tablets Dapamax Scripto-Lyte Tablets Alzam 0,25mg Tablets Alzam 0,5mg Tablets Alzam 1,0mg Muthi Wenyoni Antacid Wenyoni Muthi Vaginal Normospor Sok Compound Milk of Magnesia Captomax 25 Captomax 50 Napamol Elixir Normospor Cream Cream Okacyn Eye Drops Padax Granules Pandora Essens Propan Mist. Pot. Cit Duplex Salterpyn Syrup REGISTERED NAME Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited APPLICANT No. 3556 Government Gazette 16 December 2005 21 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/7.1.3/0272 05/7.1.3/0273 05/7.1/0274 05/7.1/0275 05/7.1/0276 05/7.1/0277 05/2.2/0278 04/2.8/0279 04/2.8/0280 05/13.1/0281 05/13.1/0282 REG. NO. NAMIBIA 05/21.2/0264 05/3.1/0265 05/2.7/0266 05/2.7/0267 05/2.7/0268 05/7.1/02769 05/10.2.2/0270 05/7.1.3/0271 Each Tablet contains Mefenamic Acid 500 mg contains Mefenamic Tablet Each Each Tablet contains Gliclazide 80 mg Tablet Each 10,0 mg contains Lisinopril Tablet Each 20,0 mg contains Lisinopril Tablet Each 5,0 mg contains Lisinopril Tablet Each Hydrochloride 60 mg contains Diltiazem Tablet Each Hydrochloride 90 mg contains Diltiazem Tablet Each 7,5 mg contains Zopiclone Tablet Each 200,0 mg, Paracetamol 350,0 mg contains: Ibuprofen Tablet Each 200 mg, Codeine Phosphate 10 mg contains: Ibuprofen Tablet Each Each Capsule contains Mefenamic Acid 250 mg Each Capsule contains Mefenamic Acid 50 mg Mefenamic Each 5 ml Suspension contains base Ketotifen Ketotifen Fumarate equiv.to Each 5 ml Syrup contains to 10 mg mg equiv. Each 1 ml solution contains Povidone Iodine 100 availlable Iodine Each 100 g Ointment contains Ichthammol 10 g STRENGTH/DOSE UNIT 200 mg Each Capsule contains Ketoprofen Capsule contains Nifedipine 30 mg Each Sustained Release 1,0 mg Hydrochloride 180 Each Sustained Release Capsule contains Diltiazem mg Hydrochloride 240 Each Sustained Release Capsule contains Diltiazem mg Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Solution Ointment DOSSAGE FORM Capsules Capsules Suspension Capsules Syrup Capsules Capsules Mefenamic Acid Mefenamic Mefenamic Acid Mefenamic APPROVED NAME OF APPROVED NAME OF Acid Mefenamic Diltiazem Hydrochloride Diltiazem Hydrochloride Zopiclone Ibuprofen, Paracetamol Ibuprofen, Codeine Phosphate Povidone Iodine Ichthammol Nifedipine Ketotifen Fumarate Lisinopril Lisinopril Lisinopril Diltiazem Hydrochloride Diltiazem Hydrochloride ACTIVE(S) Gliclazide Ketoprofen Zetomax 10 mg Tablets Zetomax 10 mg Tablets Zetomax 20 mg Tablets Zetomax 5 mg Capsules SR 180 Zildem Capsules SR 240 Zildem Tablets Zildem 60 Tablets Zildem 90 Tablets Zopimed Tablets Ibumol Tablets Ibucod Glucomed Tablets Glucomed Ketoflam Capsules Tablets Ponstel Forte 30 SR Capsules Vascard Peviderm Solution Barrs Ichthammol Ointment Ponstel S Suspension Zetofen Syrup REGISTERED NAME Ponstel 250 Capsules Industries cc Barrs Pharmaceutical Industries cc Aspen Pharmacare Limited Barrs Pharmaceutical Adcock Ingram Limited Aspen Pharmacare Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited Adcock Ingram Limited APPLICANT 22 Government Gazette 16 December 2005 No. 3556 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/16.4/0288 05/16.4/0289 05/18.6/0290 05/18.6/0291 05/21.2/0292 05/21.2/0293 05/1.2/0294 05/1.2/0295 REG. NO. NAMIBIA 05/13.1/0283 05/34/0284 05/21.5.1/0285 05/10.1/0286 05/18/0287 Each Tablet contains Phenazopyridine Hydrochloride 100,0 mg contains Phenazopyridine Tablet Each Hydrochloride 500 mg contains Metformin Tablet Each Hydrochloride 850 mg contains Metformin Tablet Each 150 mg contains Moclobemide Tablet Each 300 mg contains Moclobemide Tablet Each Each 20 ml liquid contains: Alcohol 95% 5,68 ml, Thymol 12,781 mg Alcohol 95% 5,68 ml, Each 20 ml liquid contains: Thymol 12,78 ml Alcohol 95% 4,58 ml, Each 20 ml Solution contains: STRENGTH/DOSE UNIT Povidone Iodine 10,0 g Each 100,0 g Ointment contains m/v Solution Hydrogen Peroxide 6% Beclomethasone Dipropionate 50 µg Each metered Spray contains Guaifenesin 200 mg Each 10 ml Syrup contains 2,0 g Each 100 g Cream contains Miconazole Nitrate 2,0 g Each 100 g Cream contains Miconazole Nitrate Tablets Tablets Tablets Tablets Tablets DOSSAGE FORM Ointment Solution Metered Dose Spray Syrup Solution Solution Cream Cream Alcohol 95% Thymol Thymol Alcohol 95% Alcohol 95%, Thymol Alcohol 95%, APPROVED NAME OF APPROVED NAME OF Miconazole Nitrate Metformin Hydrochloride Metformin Hydrochloride Moclobemide Moclobemide Beclomethasone Dipropionate 50 Beclomethasone Dipropionate Guaifenesin Phenazopyridine Hydrochloride Miconazole Nitrate ACTIVE(S) Povidone Iodine m/v Hydrogen Peroxide 6% Solution Moclobix 150 Tablet Moclobix 150 Tablet Moclobix 300 Listerine Antiseptic Listerine VC Gynezole Clenil Aq Nasal Spray Aq Clenil Cough Wet Benylin Dermazole Glucoformin 500 Tablets Glucoformin 850 Tablets - Darol Menthol Pyridium Cool Mint Listerine Solution REGISTERED NAME Barrs Povidone Iodine Ointment Hydrogen Peroxide Volume Solution 20 (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd (Pty) Ltd (Pty) Ltd (Pty) Ltd Industries cc Sandoz (Pty) Limited Barrs Pharmaceutical Industries cc Barrs Pharmaceutical APPLICANT Warner-Lambert SA SA Warner-Lambert Warner-Lambert SA SA Warner-Lambert SA Warner-Lambert SA Warner-Lambert No. 3556 Government Gazette 16 December 2005 23 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/20.1.1/0301 05/26/0302 05/26/0303 04/26/0304 05/26/0305 05/20.1.1/0306 05/20.1.1/0307 05/20.1.1/0308 05/2.6.5/0309 REG. NO. NAMIBIA 05/26/0296 05/26/0297 05/7.1/0298 05/20.1.1/0399 05/20.1.1/0300 Each Tablet contains Ciprofloxacin Hydrochloride equiv. to Hydrochloride equiv. contains Ciprofloxacin Tablet Each Ciprofloxacin 250 mg to Hydrochloride equiv. contains Ciprofloxacin Tablet Each Ciprofloxacin 500 mg to Hydrochloride equiv. contains Ciprofloxacin Tablet Each Ciprofloxacin 750 mg to Cefuroxime 125 mg Axetil equiv. contains Cefuroxime Tablet Each to Cefuroxime 250 mg Axetil equiv. contains Cefuroxime Tablet Each to Cefuroxime 500 mg Axetil equiv. contains Cefuroxime Tablet Each Each film coated slow release tablet contains Felodipine 5 mg Each film coated slow release Each vial contains Olanzapine 10,0mg STRENGTH/DOSE UNIT Doxorubicin Hydrochloride 10 mg Each 5 ml of Solution contains Doxorubicin Hydrochloride 50 mg Each 25 ml of Solution contains 10 mg Each 5 ml Solution contains Epirubicin Hydrochloride 50 mg Each 25 ml Solution contains Epirubicin Hydrochloride 100 mg Each 50 ml Solution contains Epirubicin Hydrochloride 200 mg Each 100 ml Solution contains Epirubicin Hydrochloride Tablets Tablets Tablets Tablets Tablets Tablets Tablets Injection DOSSAGE FORM Injection Injection Injection Injection Injection Injection Cefuroxime Axetil Cefuroxime Axetil Cefuroxime Axetil Cefuroxime Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride APPROVED NAME OF APPROVED NAME OF Epirubicin Hydrochloride Epirubicin Hydrochloride Olanzapine Felodipine Epirubicin Hydrochloride Epirubicin Hydrochloride ACTIVE(S) Doxorubicin Hydrochloride Doxorubicin Hydrochloride 50mg/25ml Epirubicin-Hexal 100mg/50ml Epirubicin-Hexal 200mg/100ml Sandoz-Cefuroxime 125 Tablets Sandoz-Cefuroxime 250 Tablets Sandoz-Cefuroxime 500 Tablets Zyprexa IM 50mg/25ml Solution for 50mg/25ml Solution for Infusion Felodipine-Hexal 5 mg Tablet Cipro-Hexal 250 mg Tablet Cipro-Hexal 500 mg Tablet Cipro-Hexal 750 mg Tablet Epirubicin-Hexal 10mg/5ml Epirubicin-Hexal REGISTERED NAME Doxorubicin-Hexal 10mg/5ml Solution for Infusion Doxorubicin-Hexal Eli Lilly (SA) Ltd Sandoz (Pty) Limited Sandoz (Pty) Limited Sandoz (Pty) Limited Hexal Pharma (SA) (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd Hexal Pharma (SA) Hexal Pharma (SA) (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd APPLICANT 24 Government Gazette 16 December 2005 No. 3556 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/11.2/0313 05/20.2.2/0311 05/20.1.2/0316 05/20.1.2/0317 05/20.1.2/0318 05/20.1.2/0319 05/20.1.2/0320 05/20.1.2/0321 05/20.1.2/0322 05/20.2.3/0323 REG. NO. NAMIBIA 05/20.2.2/0310 05/7.1/0312 05/5.4/0314 05/2.6.5/0315 Each Tablet contains Ciprofloxacin Hydrochloride equiv. to Hydrochloride equiv. contains Ciprofloxacin Tablet Each Ciprofloxacin 100 mg to Hydrochloride equiv. contains Ciprofloxacin Tablet Each Ciprofloxacin 250 mg to Hydrochloride equiv. contains Ciprofloxacin Tablet Each Ciprofloxacin 500 mg to Hydrochloride equiv. contains Ciprofloxacin Tablet Each Ciprofloxacin 750 mg Each Tablet contains Indapamide 2,5 mg Tablet Each contains Mebeverine HCl 135 mg Tablet Each mg contains Oxybutynin Hydrochloride 5 Tablet Each 60 mg, Isoniazid 30 mg contains Rifampicin Tablet Each Each Capsule contains Amoxycillin Trihydrate equiv. to Amoxycillin to equiv. Trihydrate Amoxycillin Each Capsule contains to Flucloxacillin 250 mg, Flucloxacillin Sodium Monohydarate equiv. Amoxycillin Each 5 ml of the reconstituted Suspension contains Potassium Clavulanate equiv. Amoxycillin 250 mg, to equiv. Trihydrate Acid 62,5 mg to Clavulanic Amoxycillin Each 5 ml of the reconstituted Suspension contains Potassium Clavulanate equiv. Amoxycillin 125 mg, to equiv. Trihydrate Acid 31,25 mg to Clavulanic STRENGTH/DOSE UNIT Clotrimazole 10,0mg Each 1,0g cream contains Clotrimazole 10,0mg Each 1,0g cream contains Each Capsule contains Sulpiride 50 mg 250 mg Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Topical Topical Vaginal Powder for Suspension DOSSAGE FORM Cream Cream Capsules Capsules Powder for Suspension Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride Trihydrate Amoxycillin Trihydrate Amoxycillin Amoxycillin Trihydrate Trihydrate Amoxycillin Ciprofloxacin Hydrochloride APPROVED NAME OF APPROVED NAME OF Potassium Clavulanate Potassium Clavulanate Rifampicin , Isoniazid Indapamide Mebeverine HCl Oxybutynin Hydrochloride Sulpiride Flucloxacillin Sodium Monohydarate ACTIVE(S) Clotrimazole Clotrimazole Sandoz Ciprofloxacin Sandoz Ciprofloxacin Sandoz Ciprofloxacin Sandoz Ciprofloxacin Xeraspor T Cream T Xeraspor Cream V Xeraspor 250 500 750 Sandoz Co-Amoxyclav SF Sandoz Co-Amoxyclav S Rimactazid Paed 60/30 Daptril Sandoz Mebeverine HCl 135 Sandoz Oxybutynin HCl 5 Sandoz Sulpiride 50 Rolab-Amoxycillin/ Flucloxacillin 250/250 100 REGISTERED NAME Sandoz (Pty) Limited Sandoz (Pty) Limited Sandoz (Pty) Limited Sandoz (Pty) Limited Sandoz (Pty) Limited Sandoz (Pty) Limited Sandoz (Pty) Limited Sandoz (Pty) Limited Sandoz (Pty) Limited Sandoz (Pty) Limited Qestmed (Pty) Ltd Sandoz (Pty) Limited Qestmed (Pty) Ltd Qestmed (Pty) Ltd APPLICANT No. 3556 Government Gazette 16 December 2005 25 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/11.4.3/0339 05/21.12/0330 05/1.2/0331 05/20.2.6/0332 05/5.4.1/0333 05/5.4.1/0334 05/5.4.1/0335 05/5.4.1/0336 05/13.4.3/0337 05/13.4.3/0338 REG. NO. NAMIBIA 05/20.1.2/0324 05/20.1.2/0325 05/5.7.1/0326 05/2.8/0327 05/3.1/0328 05/3.1/0329 Each tablet contains Mefloquine Hydrochloride equiv. to Mefloquine Hydrochloride equiv. Each tablet contains Mefloquine Each Tablet contains Amoxycillin Trihydrate equiv. to Amoxycillin Amoxycillin to equiv. Trihydrate Amoxycillin contains Tablet Each Acid 125 mg Clavulanic to equiv. 250mg, Potassium Clavulanate Amoxycillin to equiv. Trihydrate Amoxycillin contains Tablet Each Acid 125 mg Clavulanic to equiv. 500mg, Potassium Clavulanate contains Loratadine 10,0mg Tablet Each 500 mg contains Naproxen Tablet Each to Anhydrate equiv. Each tablet contains Paroxetine Hydrochloride to Ropinirole Each tablet contains Ropinirole Hydrochloride equiv. to Ropinirole Each tablet contains Ropinirole Hydrochloride equiv. to Ropinirole Each tablet contains Ropinirole Hydrochloride equiv. to Ropinirole Each tablet contains Ropinirole Hydrochloride equiv. 5,0mg 10,0mg Each soft gelatine capsule contains Isotretinoin 20,0mg Each soft gelatine capsule contains Isotretinoin Each Capsule contains Omeprazole 20 mg STRENGTH/DOSE UNIT Codeine Phosphate 10 mg, Ibuprofen 200 mg, Each Capsule contains; Paracetamol 250 mg Each Capsule contains Piroxicam 10 mg Each soft capsule contains Dutasteride 0.5mg Paroxetine 30,0mg 250,0mg 0,5mg 1.0mg 2.0mg Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Capsules Capsules Capsules DOSSAGE FORM Capsules Capsules Capsules Mefloquine Hydrochloride APPROVED NAME OF APPROVED NAME OF Potassium Trihydrate Amoxycillin Potassium Trihydrate Amoxycillin Ropinirole Hydrochloride Ropinirole Hydrochloride Ropinirole Hydrochloride Ropinirole Hydrochloride Isotretinoin Isotretinoin Omeprazole Loratadine Codeine Phosphate, Ibuprofen, Paracetamol Naproxen Piroxicam Dutasteride Paroxetine Hydrochloride Anhydrate ACTIVE(S) Clavulanate Clavulanate Avodart Mefliam Requip 0,5mg Requip 1mg Requip 2mg Requip 5mg Acnetane 10 mg Acnetane 20 mg Adco-Omeprazole 20 Sandoz Loratadine 10 Tablets Ibupain Forte Capsules Sandoz Naproxen 500 Sandoz Piroxicam 10 Aropax 30 REGISTERED NAME Sandoz Co-Amoxyclav Tablets 375 Sandoz Co-Amoxyclav Tablets 625 Adcock Ingram Ltd Adcock Ingram Ltd Adcock Ingram Ltd Africa (Pty) GlaxoSmithKline South Africa (Pty) GlaxoSmithKline South Africa (Pty) GlaxoSmithKline South GlaxoSmithKline South Africa (Pty) GlaxoSmithKline South Africa (Pty) Ltd Cipla Medpro (Pty) Ltd Sandoz (Pty) Limited GlaxoSmithKline South Africa (Pty) Ltd Sandoz (Pty) Limited Sandoz (Pty) Limited Sandoz (Pty) Limited Sandoz (Pty) Limited Sandoz (Pty) Limited APPLICANT 26 Government Gazette 16 December 2005 No. 3556 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/2.9/0347 05/2.9/0348 05/34/0349 05/34/0350 05/5.4/0351 05/5.4/0352 05/20.2/0353 05/20.2/0354 REG. NO. NAMIBIA 05/13.8/0340 05/13.8/0341 05/13.8/0342 05/3.1/0343 05/6.2/0344 05/6.2/0345 05/30.1/0346 Each tablet contains Amiodarone Hydrochloride 200,0mg Amiodarone Each tablet contains Each tablet contains Amiodarone Hydrochloride 100,0mg Amiodarone Each tablet contains Each tablet contains Trimethoprim 80,0mg, Sulphamethoxazole 80,0mg, Sulphamethoxazole Trimethoprim Each tablet contains Each 1,0 ml Solution contains Parecoxib Sodium equiv. to Parecoxib equiv. Each 1,0 ml Solution contains Parecoxib Sodium to Parecoxib equiv. Each 2,0 ml solution contains Parecoxib Sodium 2,0mg L-Tartrate Tolterodine Each capsule contains 4,0mg L-Tartrate Tolterodine Each capsule contains 40,0mg, Trimethoprim Each 5ml suspension contains Each dose (0.5ml) contains live attenuated: Measles Virus (Schwartz Virus Each dose (0.5ml) contains live attenuated: Measles and Rubella AM-9) 5000 CCID50, Virus strain) 1000 CCID50, Mumps RA27/3M) 1000 CCID50 (Wistar Virus 400,0mg Sulphamethoxazole 200,0mg STRENGTH/DOSE UNIT Urea 5,0g Each 50g cream contains Urea 12,5g Each 50g ointment contains Urea 1,0g Each 50g Lotion contains Diclofenac Hydroxyethylpyrrolidine 1,292g Each 100,0g gel contains 20,0 mg 40,0 mg (0,9%) Each ampoule contains Sodium Chloride 9,0mg (0,9%) Each ampoule contains Sodium Chloride 18,0mg Tablets Tablets Aventis Aventis Tablets Capsules Suspension DOSSAGE FORM Cream Ointment Lotion Gel Pharma (Pty) Limited Injection Injection Injection Injection Capsules Amiodarone Hydrochloride Amiodarone Hydrochloride Tolterodine L-Tartrate Tolterodine L-Tartrate Tolterodine , Trimethoprim , Trimethoprim APPROVED NAME OF APPROVED NAME OF Sodium Chloride Sodium Chloride Sulphamethoxazole Sulphamethoxazole Hydroxyethylpyrrolidine Hydroxyethylpyrrolidine Measles, Mumps and Rubella Live Vaccine, Parecoxib Sodium Parecoxib Sodium ACTIVE(S) Urea Urea Urea Diclofenac Arycor 200 Tablets Arycor 200 Trimovax Arycor 100 Tablets Arycor 100 Rayzon 1 ml Solvent Rayzon 2 ml Solvent Detrusitol SR 2mg Detrusitol SR 4mg Nucotrim Doctrim Suspension Rayzon 20 mg IV/IM Rayzon 40 mg IV/IM REGISTERED NAME Eulactol Cream Eulactol Heel Balm Eulactol Skin Lotion Panamor Gel (Pty) Ltd Gulf Drug Company (Pty) Ltd Gulf Drug Company (Pty) Ltd (Pty) Ltd (Pty) Ltd (Pty) Ltd (Pty) Ltd (Pty) Ltd Limited Limited Limited Adcock Ingram Ltd Pharmacare Limited Adcock Ingram Ltd Adcock Ingram Ltd APPLICANT Pfizer Laboratories Pfizer Laboratories Pfizer Laboratories Pfizer Laboratories Pfizer Laboratories Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Sanofi-Synthelabo (Pty) Pharma (Pty) Aventis Pfizer Laboratories No. 3556 Government Gazette 16 December 2005 27 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/20.2.2/0360 05/3.1/0361 05/20.2.8/0362 05/20.2.8/0363 05/20.2.8/0364 05/20.2.8/0365 05/20.2.8/0366 05/20.2.8/0367 05/21.2/0368 05/21.8.1/0369 REG. NO. NAMIBIA 05/2.7/0355 05/20.1.1/0356 05/5.2/0357 05/5.2/0358 05/20.2.2/0359 Each capsule contains Oxytetracycline Hydrochloride equiv. to to Hydrochloride equiv. Each capsule contains Oxytetracycline to Oestradiol 0,39µg Each patch contains Oestradiol Hemihydrate equiv. Each tablet contains Lamivudine 150,0mg, Zidovudine 300mg Each tablet contains Lamivudine 150,0mg, Zidovudine mg Each tablet contains Metformin Hydrochloride 1000,0 STRENGTH/DOSE UNIT 500,0mg, Each tablet contains Paracetamol Oxytetracycline 250,0mg Hydrochloride 10,0 mg Each tablet contains Propranolol Hydrochloride 40,0 mg Each tablet contains Propranolol Each 1g cream contains Clotrimazole 10,0mg Each 1g cream contains Clotrimazole 10,0mg Each capsule contains Indomethacin 25,0mg Each 5ml solution contains Zidovudine 50,0mg Each tablet contains Zidovudine 300,0mg Each tablet contains Nevirapine 200,0mg Each 1ml solution contains Lamivudine 10,0mg Each tablet contains Lamivudine 150,0mg Tablets Tablets Tablets Tablets Tablets Tablets Tablets Transdermal Tablets Patch DOSSAGE FORM Capsules Cream Cream Capsules Solution Solution APPROVED NAME OF APPROVED NAME OF Zidovudine Nevirapine Lamivudine Lamivudine Zidovudine, Lamivudine Metformin Hydrochloride Oestradiol Propranolol Hydrochloride Propranolol Hydrochloride Propranolol Hydrochloride Clotrimazole 10,0mg Clotrimazole Indomethacin Zidovudine ACTIVE(S) Paracetamol Oxytetracycline Hydrochloride Aspen Zidovudine 300 mg Aspen Nevirapine 200 mg Aspen Lamivudine Syrup Aspen Lamivudine 150 mg Aspen Zidolam Glucophage 1000mg Estradot 25 Indoblok 10 Indoblok 40 Gynezol Clomaderm Gulf Indomethacin 25 Aspen Zidovudine Syrup REGISTERED NAME Painblok Nucotet (Pty) Ltd Pharmacare Limited Merck (Pty) Ltd SA Novartis South frica Pharmacare Limited Pharmacare Limited Pharmacare Limited Pharmacare Limited Gulf Drug Company (Pty) Ltd Pharmacare Limited (Pty) Ltd Gulf Drug Company (Pty) Ltd Gulf Drug Company (Pty) Ltd Gulf Drug Company (Pty) Ltd Gulf Drug Company (Pty) Ltd Gulf Drug Company (Pty) Ltd Gulf Drug Company APPLICANT 28 Government Gazette 16 December 2005 No. 3556 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/21.8.2/0375 05/5.3/0376 05/7.1.3/0377 05/7.1.3/0378 05/20.1.1/0379 05/20.1.1/0380 05/20.1.1/0381 05/28/0382 05/28/0383 REG. NO. NAMIBIA 05/21.8.1/0370 05/21.8.1/0371 05/21.8.1/0372 05/21.8.1/0373 05/21.8.2/0374 . to . to Each tablet contains Valsartan 80,0mg Valsartan Each tablet contains 160,0mg Valsartan Each tablet contains Each patch contains Oestradiol Hemihydrate equiv. to Oestradiol to Oestradiol Hemihydrate equiv. Each patch contains Oestradiol to Oestradiol Hemihydrate equiv. Each patch contains Oestradiol to Oestradiol Hemihydrate equiv. Each patch contains Oestradiol to Oestradiol Hemihydrate equiv. Each patch contains Oestradiol to Estradiol equiv. Each phase I patch contains Estradiol Hemihydrate equiv 4,33mg. Each phase II patch contains Estradiol Hemihydrate Acetate 2,70mg Oestradiol 0,62mg, Norethisterone to Estradiol equiv. Each phase I patch contains Estradiol Hemihydrate equiv 4,33mg. Each phase II patch contains Estradiol Hemihydrate Acetate 4,80mg Oestradiol 0,512mg, Norethisterone to equiv. Tartrate Each 1,0ml Solution contains Rivastigmine Hydrogen to Cefuroxime 250,0mg Each vial contains; Cefuroxime sodium equiv. to Cefuroxime 750,0mg Each vial contains; Cefuroxime sodium equiv. to Cefuroxime 1,5g Each vial contains; Cefuroxime sodium equiv. Each 100ml Powder contains Barium Sulphate 98,0g 4,871g Each 100ml suspension contains Barium Sulphate STRENGTH/DOSE UNIT 0,585mg 0,78mg 1,17mg 1,56mg Rivastgmine 2,0mg Tablets Tablets Transdermal Transdermal Transdermal Transdermal Transdermal Transdermal Transdermal Transdermal Powder Suspension DOSSAGE FORM Patch Patch Patch Patch Patch Patch Solution Injection Injection Injection Valsartan Valsartan APPROVED NAME OF APPROVED NAME OF Cefuroxime Sodium Cefuroxime Sodium Cefuroxime Sodium Barium Sulphate Barium Sulphate Oestradiol Oestradiol Oestradiol, Norethisterone Acetate Oestradiol, Norethisterone Acetate Rivastigmine ACTIVE(S) Oestradiol Oestradiol Diovan 80 Tablets Diovan 80 Tablets Diovan 160 Axetine 250mg Axetine 750mg Axetine 1,5g Axim E-Z-HD Axim E-Z-Cat Estradot 75 Estradot 100 Estalis Sequi 50/140 (Phase I and II Estalis Sequi 50/250 (Phase I and II Exelon 2mg/ml Oral Solution REGISTERED NAME Estradot 37.5 Estradot 50 (Pty) Ltd Axim Pharmaceuticals (Pty) Ltd Specpharm (Pty) Ltd Specpharm (Pty) Ltd Axim Pharmaceuticals Novartis South frica (Pty) Ltd Specpharm (Pty) Ltd (Pty) Ltd Novartis South frica (Pty) Ltd (Pty) Ltd Novartis South frica (Pty) Ltd Novartis South frica Novartis South frica (Pty) Ltd Novartis South frica (Pty) Ltd Novartis South frica (Pty) Ltd Novartis South frica (Pty) Ltd Novartis South frica APPLICANT No. 3556 Government Gazette 16 December 2005 29 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/11.4.3/0395 05/11.4.3/0396 05/11.4.3/0397 Z/5.8/0389 05/16.4/0390 05/2.7/0391 05/2.7/0392 05/7.4/0393 05/24/0394 05/13.9/0398 REG. NO. NAMIBIA 05/28/0384 05/28/0385 05/28/0386 05/28/0387 05/7.1.3/0388 . . Each tablet contains Ibuprofen 200mg and Pseudoephedrine HCL 30mg HCL Each tablet contains Ibuprofen 200mg and Pseudoephedrine Each tablet contains Pantoprazole Sodium Sequihydarte 22.57mg equiv Each tablet contains Pantoprazole Sodium Sequihydarte 45.1mg equiv Each tablet contains Pantoprazole Sodium Sequihydarte Each lozenges contains: Amylmetacresol 0,6mg, Dichlorobenzyl Each lozenges contains: to Pantoprazole equiv. Each vial contains Pantoprazole Sodium 42.3mg Aescin 1g, Diethylamine Salycylate 5g Each 100g gel contains to Pantoprazole 40,0mg 40,0mg STRENGTH/DOSE UNIT Barium Sulphate 96,3045g Each 100g Powder contains contains Barium Sulphate 100,0g Each 100ml Suspension contains Barium Sulphate 105,0g Each 100ml Suspension Barium Sulphate 96,0g Each 100g powder contains Each tablet contains Enalapril Maleate 5,0mg Alcohol 1,2mg, Lidocaine HCl. 10,0mg Paracetamol Suppositories 125mg Paracetamol Suppositories 250mg Each dragee contains Silymarin 70,0mg 614,8mg Each tablet contains Magnesium-L-Aspartate HCl to Pantoprazole 20,0mg Tablets Tablets Tablets Tablets Tablets Injection Gel DOSSAGE FORM Powder Suspension Suspension Powder Lozenge Suppository Suppository Dragee Aescin , Diethylamine Salycylate Ibuprofen ,Pseudoephedrine HCL Ibuprofen ,Pseudoephedrine HCL Amylmetacresol, Dichlorobenzyl APPROVED NAME OF APPROVED NAME OF Paracetamol Silymarin Magnesium-L-Aspartate HCl Pantoprazole Sodium Sequihydarte Pantoprazole Sodium Sequihydarte Pantoprazole Sodium Barium Sulphate Barium Sulphate Enalapril Maleate Alcohol, Lidocaine HCl. Paracetamol ACTIVE(S) Barium Sulphate Barium Sulphate Hypace 5mg Tablets Hypace 5mg Tablets Magnesit Axim Polibar ACB Axim Polibar Empamed 250mg Suppositories Legalon 70 Pantoloc 20 Pantoloc 40 Pantoloc IV Reparil-Gel Axim Polibar Plus Nurofen Cold & Flu Strepsil Plus Empamed 125mg Suppositories REGISTERED NAME Axim E-Z-Paque Axim Polibar Rapid Byk Madaus (Pty) Ltd Byk Madaus (Pty) Ltd Byk Madaus (Pty) Ltd Byk Madaus (Pty) Ltd Byk Madaus (Pty) Ltd Byk Madaus (Pty) Ltd Byk Madaus (Pty) Ltd Boots Healthcare (SA) Pty Ltd Byk Madaus (Pty) Ltd Contractors (Pty) Ltd Boots Healthcare (SA) Pty Ltd Axim Pharmaceuticals (Pty) Ltd Pharmaceutical (Pty) Ltd Axim Pharmaceuticals (Pty) Ltd Axim Pharmaceuticals (Pty) Ltd Axim Pharmaceuticals APPLICANT 30 Government Gazette 16 December 2005 No. 3556 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.05.18 2005.05.18 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 2005.03.14 REGISTRATION REGISTRATION DATE 05/21.2/0411 05/20.2.8/0407 05/20.2.8/0408 05/20.2.8/0409 05/20.2.8/0409 05/20.2.8/0410 05/21.2/0412 05/21.2/0413 05/21.1/0414 05/20.2.8/0415 05/20.2.8/0416 REG. NO. NAMIBIA 05/18.4/0399 05/8.3/0400 05/28/0401 05/28/0402 05/28/0403 05/28/0404 05/28/0405 05/5.2/0406 Aspart Each 100g of granules contains: Citric Acid 13.044g, Potassium Citrate Citric Each 100g of granules contains: to III Hydroxide Sucrose Complex equiv. Each ampoule contains Iron Iodine to 200mg 408 equiv. 1ml contains: Iomeprol Iodine to 250mg 510 equiv. 1ml contains: Iomeprol Iodine to 300mg 612 equiv. 1ml contains: Iomeprol Iodine to 350mg 714 equiv. 1ml contains: Iomeprol to 400mg Iodine 1ml contains: Iomeprol 816 equiv. to Acebutolol Hydrochloride equiv. Each 5 ml njection contains contains Insulin Each 1ml aqueous, neutral, and sterile solution Each tablet contains Repaglinide 2,0mg 100 IU Each tablet contains Nevirapine 200,0mg Each tablet contains Lamivudine 150,0mg STRENGTH/DOSE UNIT 41.153 45.397, Sodium Citrate 100,0mg of Iron Acebuttolol base 25,0mg Each 5ml solution contains Lamivudine 50,0mg Each 5ml solution contains Zidovudine 50,0mg Each tablet contains Zidovudine 300,0mg Each tablet contains Nevirapine 200,0mg 50,0mg Each 5ml suspension contains Nevirapine (as a hemihydrate) Each tablet contains Repaglinide 0,5mg Each tablet contains Repaglinide 1,0mg Tablets Tablets Tablets Tablets Tablets Tablets Tablets Injection DOSSAGE FORM Granules Injection Injection Injection Injection Injection Injection Injection Solution Solution Suspension Insulin Aspart Insulin Acebutolol Hydrochloride APPROVED NAME OF APPROVED NAME OF , Potassium Citrate, Acid Citric Nevirapine Repaglinide Repaglinide Repaglinide Nevirapine Lamivudine Iomeprol Iomeprol Iomeprol Iomeprol Iomeprol Lamivudine Zidovudine Zidovudine Nevirapine ACTIVE(S) Sodium Citrate Iron III Hydroxide Sucrose Complex Venofer Venofer Nevimune Oral Suspension Novonorm Novonorm Novonorm Novorapid subcutenous inj. Nevran Lamaid Imeron 200 Imeron 250 Imeron 300 Imeron 350 Imeron 400 Sectral Injection Lamivir Solution Zidovir Solution Zidovir 300 Nevimune REGISTERED NAME Uralyt-U Ranbaxy (SA) (Pty) Ltd Novo Nordisk (Pty) Limited Ranbaxy (SA) (Pty) Ltd Limited Novo Nordisk (Pty) Limited Novo Nordisk (Pty) Limited Novo Nordisk (Pty) Cipla Medpro (Pty) Ltd Cipla Medpro (Pty) Ltd Cipla Medpro (Pty) Ltd Cipla Medpro (Pty) Ltd Cipla Medpro (Pty) Ltd Pharmaplan (Pty) Ltd Limited Pharmaplan (Pty) Ltd Pharmaplan (Pty) Ltd Pharmaplan (Pty) Ltd Pharmaplan (Pty) Ltd Byk Madaus (Pty) Ltd Byk Madaus (Pty) Ltd APPLICANT Aventis Pharma (Pty) Aventis No. 3556 Government Gazette 16 December 2005 31 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.05.18 2005.05.18 2005.07.20 2005.07.20 2005.07.20 2005.07.20 REGISTRATION REGISTRATION DATE 05/11.4.1/0422 05/4.4/0423 05/5.7.1/0424 05/20.1.2/0425 05/20.1.1/0426 05/13.4.1/0427 05/13.4.1/0428 05/7.1.3/0429 05/20.2.2/0430 05/18.8/0431 05/26/0432 05/26/0433 REG. NO. NAMIBIA 05/20.2.8/0417 05/20.2.8/0418 05/20.2.8/0419 05/10.2.1/0420 05/28/0421 Each tablet contains Tenofovir Disoproxil Fumarate 300,0mg equiv. to Disoproxil Fumarate 300,0mg equiv. Tenofovir Each tablet contains 245,0mg Disoproxil Tenofovir Amoxycillin 875mg, Clavulanic Acid 125mg Tablets Acid 125mg Amoxycillin 875mg, Clavulanic 40mg Tablets Valsartan Miconazole Nitrate Tablets (buccal) 10mg Tablets Miconazole Nitrate (14 tablets); Tablets to Estradiol 1mg Estradiol Hemihydrate equiv. 5mg to Esradiol 1mg and Dydrogesterone Estradiol Hemihydrate equiv. (14tablets) Tablets Each actuation contains Salbutamol Sulphate equiv. to Salbutamol Salbutamol Sulphate equiv. Each actuation contains Anhydrous Citric Each unit dose contains: Sodium Bicarbonate 2,2056g, Infliximab, Dry Injection, 100mg for 10ml Acetate and Zinc Each ml contains Erythromycin 40mg (4.0% w/v) Emulsion Topical Hydrocortisone 17-Butyrate 1mg/g base Vinorelbine to Soft Gelatine Capsules; equiv. Tartarate Vinorelbine base Vinorelbine to Soft Gelatine Capsules; equiv. Tartarate Vinorelbine 20mg, 30mg, STRENGTH/DOSE UNIT 100,0mg Each tablet contains Zidovudine 300,0mg Each tablet contains Zidovudine 100µg (2% m/m) Barium Sulphate 2.0896g/100ml Acid 1,5284g Each 1 ml Syrup contains Loratadine 1 mg 12mg (1.2% w/v) in a complex Hydrocortisone 17-Butyrate 1mg/g Cream Tablets Tablets Tablets Tablets Tablets Tablets Tablets Capsules Capsules DOSSAGE FORM Inhalaer Powder Injection Syrup Lotion Emulsion Cream Tenofovir Disoproxil Fumarate Disoproxil Fumarate Tenofovir Valsartan Valsartan Tartarate Vinorelbine Tartarate Vinorelbine Sodium Bicarbonate, Anhydrous Sodium Bicarbonate, Acid Citric Infliximab, Acid Amoxycillin, Clavulanic Acetate Erythromycin, Zinc APPROVED NAME OF APPROVED NAME OF Hydrocortisone 17-Butyrate Hydrocortisone 17-Butyrate Miconazole Nitrate Estradiol Hemihydrate, Dydrogesterone Salbutamol Sulphate Barium Sulphate Loratadine ACTIVE(S) Zidovudine Zidovudine Tibozole Tibozole Viread® Venteze-Eco Locoid Crelo Locoid Lipocream Diovan 40 mg tablets Femoston-Conti Navelbine Oral 20mg Navelbine Oral 30mg Axim Readicat Axim E-Z-Gas Revellex 100mg Clarinese Syrup Forcid Solutab 875/125 Zineryt-Lotion REGISTERED NAME Zidaid Zidaid (Pty) Ltd Solvay Pharma (Pty) Ltd Pharmaplan (Pty) Ltd Novartis Pharma S.A Janssen Pharmaceutica Pharmaplan (Pty) Ltd Pharmaplan (Pty) Ltd Aspen Pharmacare Limited Pharmaplan (Pty) Ltd Axim Pharmaceuticals (Pty) Ltd Schering-Plough Axim Pharmaceuticals (Pty) Ltd Gilead Sciences, Inc Pharmacare Ltd Ranbaxy (SA) (Pty) Ltd Ranbaxy (SA) (Pty) Ltd APPLICANT Tema Medical (Pty) Ltd Tema Medical (Pty) Ltd Tema 32 Government Gazette 16 December 2005 No. 3556 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 REGISTRATION REGISTRATION DATE 05/11.5/0439 05/11.5/0441 05/11.5/0442 05/1.2/0440 05/13.6/0443 05/16.4/0444 05/16.4/0445 05/21.8.2/0446 05/20.1.1/0447 05/20.1.1/0448 REG. NO. NAMIBIA 05/26/0434 05/26/0435 05/14.1/0436 05/8.4/0437 05/8.4/0438 Each Tablet contains Levonorgestrel 0.1mg and Ethinylestradiol 0.1mg contains Levonorgestrel Tablet Each Lithium Carbonate Tablets 250mg Tablets Lithium Carbonate Vinorelbine Tartarate Soft Gelatine Capsules; equiv. to Vinorelbine base base Vinorelbine to equiv. Soft Gelatine Capsules; Tartarate Vinorelbine base Vinorelbine to equiv. Soft Gelatine Capsules; Tartarate Vinorelbine Extract; Cells Yeast Alcohol Soluble contains 1g Each 100g of Ointment Alverine Citrate 6.20g, Each 10g of Coated Granules contains: Sterculia Acid 2.5g Salicylic 10gm Ointment contains: Podophyllum Resin 2.0g, 0.02mg, 7green placebo tablets to Ceftriaxone Each 10ml vial contains Ceftriaxone Sodium equiv 250mg Ceftriaxone 500mg Each vial contains Ceftriaxone Sodium equiv to STRENGTH/DOSE UNIT 40mg 80mg 3g Shark Liver Oil Sodium Chloride 9g per 1000ml Hydroxyethylstarch 100g, 1000ml Hydroxyethylstarch 60g, Sodium Chloride 9g per 0.05g Each 10gm of granules contains Sterculia 6.2g Frangula 0.8g Each 10gm of granules contains Sterculia 6.2g, (equiv to 0.003g of Each 1ml of solution contains: Extract Rhei 0.05g 0.01g, Ethanol 96% 59.5% Acid Anthraquinone), Salicylic glycosides v/v salicylate 0.5g 100ml of solution contains Hexetidine 0.1g, Choline Tablets Large Large Large Tablets Injection Injection DOSSAGE FORM Capsules Capsules Ointment volume Infusion volume Infusion Granules Granules Granules Ointment Solution Solution Levonorgestrel, Ethinylestradiol Levonorgestrel, Extract Rhei , Salicylic Acid, Extract Rhei , Salicylic Alcohol Soluble Yeast Cells Yeast Alcohol Soluble Alverine Citrate Sterculia, APPROVED NAME OF APPROVED NAME OF Tartarate Vinorelbine Tartarate Vinorelbine Sterculia , Frangula Podophyllum Resin, Salicylic Acid Ethanol 96% 59.5% v/v Hexetidine, Choline salicylate Ceftriaxone Sodium Ceftriaxone Sodium Extract, Shark Liver Oil Hydroxyethylstarch, Sodium Chloride Hydroxyethylstarch, Sodium Chloride Lithium Carbonate Sterculia ACTIVE(S) Loette Tablets - 28 Tablets Loette Hemohes 6% (IV Hemohes 6% (IV Hemohes 10% (IV Hemohes 10% (IV Normacol Plus Pyralvex Givalex Ceftriaxone-Fresenius 250mg Ceftriaxone-Fresenius 500mg Preparation H Ointment Solution) Solution) Alvercol Camcolit 250mg Normacol REGISTERED NAME Navelbine Oral 40mg Navelbine Oral 80mg Posalfilin Bodene (Pty) Limited (Pty) Ltd Bodene (Pty) Limited B/Braun Medical (Pty) Limited B/Braun Medical (Pty) Limited Healrhcare APPLICANT Norgine (Pty) Ltd (Pty) Norgine Ltd (Pty) Norgine Ltd (Pty) Norgine Ltd (Pty) Norgine Ltd (Pty) Norgine Ltd (Pty) Norgine Africa South Wyeth Tema Medical (Pty) Ltd Medical (Pty) Tema Consumer Wyeth Ltd (Pty) Norgine Tema Medical (Pty) Ltd Medical (Pty) Tema No. 3556 Government Gazette 16 December 2005 33 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 REGISTRATION REGISTRATION DATE 05/2.1/0455 05/2.1/0456 05/2.1/0457 05/2.1/0458 05/2.1/0459 05/22.1.1/0460 05/25.2/0461 05/25.2/0462 REG. NO. NAMIBIA 05/20.1.1/0449 05/20.1.1/0450 05/20.1.1/0451 05/7.1.3/0452 05/34/0453 05/2.1/0454 Losartan Potassium Tablets 100 mg Tablets Losartan Potassium Ciprofloxacin Infusion, 200mg/100ml Ciprofloxacin Infusion, Purified Each 100 ml Emulsion for Infusion contains a combination Soybean Oil (20%) 20,00 g Olive Oil (80%) and Purified Combination Parenteral Infusioin STRENGTH/DOSE UNIT Sodium equiv to Ceftriaxone 1g Each vial contains Ceftriaxone Sodium equiv to Ceftriaxone 2g Each vial contains Ceftriaxone 75 g, Sodium Chloride 5,4 g, Sodium Each 1 lt contains Icodextrin 257 mg, Magnesium Chloride 51 mg Lactate 4,5 g, Calcium Chloride 10 mg Each ml Emulsion for Injection contains Propofol 10 mg Each ml Emulsion for Injection contains Propofol 10 mg Each ml Emulsion for Injection contains Propofol 20 mg Each ml Emulsion for Injection contains Propofol 20 mg Each ml Emulsion for Injection contains Propofol 20 mg Each ml Emulsion for Injection contains Propofol and multivitamins Mulicomponent Powder for Injection (Multivitamins with minerals) Tablets Large Large Injection volume Parenteral DOSSAGE FORM Injection Injection Injection volume Parenteral Injection Injection Injection Injection Injection Injection Injection Ciprofloxacin Purified Olive Oil , and Purified Purified Olive Oil , and Purified APPROVED NAME OF APPROVED NAME OF Propofol Propofol Combination Soybean Oil Combination Parenteral Infusioin Losartan Potassium Combination Propofol Propofol Propofol Propofol ACTIVE(S) Ceftriaxone Sodium Ceftriaxone Sodium Spec-Topistin Infusion Spec-Topistin Tablets Cozaar 100mg (20 ml) Sabax Propofol 2% (50 ml) Sabax Propofol 2% (100 ml) Cernevit Clinoleic Oliclinomel N4-550 Extraneal (Peritoneal Dialysis Solution) Sabax Propofol 1% (20 ml) Sabax Propofol 1% (50 ml) Sabax Propofol 1% (100 ml) Sabax Propofol 2% REGISTERED NAME Ceftriaxone-Fresenius 1g Ceftriaxone-Fresenius 2g Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Adcock Ingram Critical Care (Pty) Ltd Specpharm (Pty) Ltd MSD Pty Ltd Bodene (Pty) Limited Bodene (Pty) Limited APPLICANT 34 Government Gazette 16 December 2005 No. 3556 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 REGISTRATION REGISTRATION DATE 05/25.2/0467 05/25.2/0468 05/34/0469 05/34/0470 05/34/0471 05/34/0472 05/30.1/0473 REG. NO. NAMIBIA 05/25.2/0463 05/25.2/0464 05/25.2/0465 05/25.2/0466 Combination Peritoneal Dialysis Solution with Amino Acids Amino Combination Peritoneal Dialysis Solution with Cholera O1 Inaba and Ogawa, Vibrio dose of oral suspension contains A aproximately 1x 10 vibrios (heat/formalin strains, Tor classic and E1 saline solution inactivated), cholera toxin B subunit 1 mg and buffered STRENGTH/DOSE UNIT Infusioin Combination Parenteral Infusioin Combination Parenteral Infusioin Combination Parenteral Combination Parenteral Infusioin Combination Parenteral Infusioin Combination Parenteral Infusioin Combination Peritoneal Dialysis Solution Combination Peritoneal Dialysis Solution Combination Peritoneal Dialysis Solution Large Large Large Large Large Large Large Large Injection Injection DOSSAGE FORM volume Parenteral volume Parenteral volume Parenteral volume Parenteral volume Parenteral volume Parenteral Injection Injection Injection APPROVED NAME OF APPROVED NAME OF Combination Peritoneal Dialysis Solution Combination Peritoneal Dialysis Solution Combination Peritoneal Dialysis Solution Combination Peritoneal Dialysis Acids Amino Solution with Combination Combination Parenteral Infusioin Combination Parenteral Combination Parenteral Infusioin Combination Parenteral Infusioin Combination Parenteral Infusioin ACTIVE(S) Infusioin Combination Parenteral Infusioin Combination Parenteral Physioneal Glucose 1,36% w/v / 13,6 mg/ml Physioneal Glucose 2,27% w/v / 22,7 mg/ml Physioneal Glucose 3,86% w/v / 38,6 mg/ml Nutrineal PD4 with Acids Amino 1,1% Dukoral Oliclinomel N6-900 Oliclinomel N6-900E Oliclinomel N7-1000 Oliclinomel N7-1000E REGISTERED NAME Oliclinomel N4-550E Oliclinomel N5-800E Care (Pty) Ltd Limited Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Care (Pty) Ltd Adcock Ingram Critical Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd Adcock Ingram Critical Care (Pty) Ltd APPLICANT Aventis Pharma (Pty) Aventis No. 3556 Government Gazette 16 December 2005 35 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 REGISTRATION REGISTRATION DATE 05/7.1/0479 05/13.4.1/0480 05/10.2.1/0481 05/7.1/0482 05/7.1/0483 05/7.5/0484 05/7.1/0485 05/5.7.1/0486 REG. NO. NAMIBIA 05/30.1/0474 05/30.1/0475 05/7.1/0477 05/7.1/0478 . to Each Tablet contains Bezafibrate 200 mg contains Bezafibrate Tablet Each Each Tablet contains Rosuvastatin 10 mg (as Rosuvastatin Calcium) contains Rosuvastatin 10 mg (as Rosuvastatin Tablet Each 20 mg (as Rosuvastatin Calcium) contains Rosuvastatin Tablet Each 40 mg (as Rosuvastatin Calcium) contains Rosuvastatin Tablet Each to Doxazocin 4,0 mg Each tablet contains Doxazocin Mesylate equiv. to Doxazocin 2,0 mg Mesylate equiv. contains Doxazocin Tablet Each to Doxazocin 1,0 mg Mesylate equiv. contains Doxazocin Tablet Each Dihydrochloride 10 mg contains Cetirizine Tablet Each Each gram cream contains : Betamethasone Valerate 0,5 mg, Tolnaftate Tolnaftate 0,5 mg, Valerate Each gram cream contains : Betamethasone Powder equiv Each metered actuation contains Salbutamol Sulphate STRENGTH/DOSE UNIT powder for injection (0,5 ml) contains: 50 Each dosage of a freeze-dried in W-135 and Y A, C, from each of Groups µg of the “isolated product” solution an isotonic sodium chloride Freeze dried Powder for Injection Each dose of 1 ml of reconstituted inactivated rabies virus contains at least 2,5 IU of 10 mg 10,0 mg, Gentamicin Sulphate 1,0 mg, Clioquinol Salbutamol Base 95 µg Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets DOSSAGE FORM Injection Injection Cream Inhalaer Bezafibrate Betamethasone Valerate, Valerate, Betamethasone , Gentamicin Sulphate, Tolnaftate APPROVED NAME OF APPROVED NAME OF Salbutamol Sulphate Doxazocin Mesylate Doxazocin Mesylate Doxazocin Mesylate Cetirizine Dihydrochloride Rosuvastatin Calcium Rosuvastatin Calcium Rosuvastatin Calcium Clioquinol ACTIVE(S) Combination Combination AP Cetirizine 10 mg AP Adco-Salbutamol Clickhaler Doxacar 4 mg Doxacar 2 mg Bezachol Doxacar 1 mg Crestor 10 Crestor 20 Crestor 40 Quadriderm Cream REGISTERED NAME Menomune (Meningococcal Vaccine) Polysacharide Rabivac Limited Aspen Pharmacare Limited Aspen Pharmacare Limited Aspen Pharmacare Limited Aspen Pharmacare Limited Aspen Pharmacare Adcock Ingram Limited Pharmaceuticals (Pty) Ltd Schering-Plough (Pty) Ltd Pharmaceuticals (Pty) Ltd AstraZeneca Pharmaceuticals (Pty) Ltd AstraZeneca Biovac S.A. (Pty) Ltd AstraZeneca Limited APPLICANT Aventis Pharma (Pty) Pharma (Pty) Aventis 36 Government Gazette 16 December 2005 No. 3556 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 REGISTRATION REGISTRATION DATE 05/7.1/0492 05/7.1/0493 05/21.12/0494 05/5.4.1/0495 05/1.2/0496 05/7.3.3/0497 05/7.3.3/0498 05/1.4.4/0499 05/1.4.4/0500 REG. NO. NAMIBIA 05/2.6.5/0487 05/2.6.5/0488 05/7.1/0489 05/7.1/0490 05/7.1/0491 Each Tablet contains Clozapine 25 mg Tablet Each contains Clozapine 100 mg Tablet Each contains Pravastatin 40 mg Tablet Each contains Simvastatin 40 mg Tablet Each 20 mg contains Pravastatin Tablet Each 20 mg contains Simvastatin Tablet Each 10 mg contains Pravastatin Tablet Each 250 mg contains Flutamide Tablet Each Hydrochloride 10 mg contains Selegiline Tablet Each to Anhydrate equiv. Hydrochloride contains Paroxetine Tablet Each Hydrochloride 80 mg contains Sotalol Tablet Each Hydrochloride 160 mg contains Sotalol Tablet Each Each Capsule contains Trazodone Hydrochloride 50 mg Trazodone Each Capsule contains Hydrochloride 100 mg Trazodone Each Capsule contains STRENGTH/DOSE UNIT Paroxetine 20 mg Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Capsules Capsules DOSSAGE FORM Trazodone Hydrochloride Trazodone Hydrochloride Trazodone APPROVED NAME OF APPROVED NAME OF Selegiline Hydrochloride Paroxetine Hydrochloride Anhydrate Sotalol Hydrochloride Sotalol Hydrochloride Pravastatin Simvastatin Pravastatin Simvastatin Pravastatin Flutamide ACTIVE(S) Clozapine Clozapine Trazin 50 mg Trazin 100 mg Trazin AP Simvastatin 20 mg AP AP Simvastatin 40 mg AP Selepark 10 mg Deparoc 20 mg Sotabloc 80 mg Sotabloc 160 mg Aspen Pravastatin 40 mg Aspen Pravastatin 20 mg Aspen Pravastatin 10 mg Proscan REGISTERED NAME Clonex 25 mg Clonex 100 mg Limited Aspen Pharmacare Limited Aspen Pharmacare Limited Aspen Pharmacare Limited Aspen Pharmacare Limited Aspen Pharmacare Limited Aspen Pharmacare Limited Aspen Pharmacare Limited Aspen Pharmacare Limited Aspen Pharmacare Limited Aspen Pharmacare Limited Aspen Pharmacare Limited Aspen Pharmacare Limited Aspen Pharmacare Limited Aspen Pharmacare APPLICANT No. 3556 Government Gazette 16 December 2005 37 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 REGISTRATION REGISTRATION DATE 05/26/0511 05/21.8/0506 05/2.9/0507 05/34/0508 05/7.1/0509 05/26/0510 05/20.1.1/0512 05/20.1.1/0513 REG. NO. NAMIBIA 05/8.2/0501 05/8.2/0502 05/8.2/0503 05/15.4/0504 05/21.8/0505 Each Tablet contains Warfarin Sodium Clathrate equiv. to Warfarin Warfarin to Clathrate equiv. Sodium Warfarin contains Tablet Each Warfarin to Clathrate equiv. Sodium Warfarin contains Tablet Each Warfarin to Clathrate equiv. Sodium Warfarin contains Tablet Each Each film coated tablet contains Cefuroxime Axetil equiv. to Cefuroxime to equiv. Axetil Cefuroxime contains tablet coated film Each Cefuroxime to equiv. Axetil Cefuroxime contains tablet coated film Each Each Tablet contains Conjugated Oestrogen 0,3 mg, contains Conjugated Tablet Each Acetate 1,5 mg Medroxyprogesterone Oestrogen 0,45 mg, contains Conjugated Tablet Each Acetate 1,5 mg Medroxyprogesterone Each 2ml ampoule contains Tramadol 100,0mg Tramadol Each 2ml ampoule contains 500,0mg 250,0mg STRENGTH/DOSE UNIT Sodium 5 mg Sodium 3mg Sodium 1mg Epinastine Hydrochloride 0,5 mg Each 1 ml Eye drops contain Each tablet contains Bupropion Hydrochloride 150,0mg Each tablet contains Pravastatin Sodium 40,0mg 10mg Each 20ml Solution for Infusion contains Cisplatin 50mg Each 100ml Solution for Infusion contains Cisplatin Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets Tablets DOSSAGE FORM Eye Drops Injection Injection Injection Warfarin Sodium Clathrate Warfarin Sodium Clathrate Warfarin Sodium Clathrate Warfarin Cefuroxime Axetil Cefuroxime Axetil Cefuroxime Tramadol Tramadol APPROVED NAME OF APPROVED NAME OF Pravastatin Sodium Cisplatin Cisplatin Epinastine Hydrochloride Epinastine Hydrochloride Conjugated Oestrogen, Acetate Medroxyprogesterone Conjugated Oestrogen, Acetate Medroxyprogesterone Bupropion Hydrochloride ACTIVE(S) Tramahexal 100mg/2ml Tramahexal SR Wellbutrin Tablets Pranalip 40mg Aspen Warfarin 5 mg Warfarin Aspen 3 mg Warfarin Aspen 1 mg Warfarin Aspen Cisplatin-Hexal 10mg/20ml Solution for Infusion Cisplatin-Hexal 50mg/100ml Solution for Infusion ZinnaHexal 500mg Tablets ZinnaHexal 250mg Tablets Relestat Eye Drops Premelle LD-0,3/1,5 Premelle LD-0,45/1,5 Solution for Injection REGISTERED NAME (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd Hexal Pharma (SA) Hexal Pharma (SA) (Pty) Ltd (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd (PTY) Ltd Hexal Pharma (SA) (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd (Pty) Ltd Pharmaceuticals (Pty) Ltd Limited Aspen Pharmacare Limited Aspen Pharmacare Limited Aspen Pharmacare APPLICANT GlaxoSmithKline SA GlaxoSmithKline SA Allergan Allergan Africa South Wyeth Africa South Wyeth 38 Government Gazette 16 December 2005 No. 3556 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.07.20 2005.08.11 REGISTRATION REGISTRATION DATE 05/2.2/0522 05/20.2.8/0523 REG. NO. NAMIBIA 05/20.1.1/0514 05/20.12/0515 05/21.12/0516 05/20.1.2/0517 05/20.1.2/0518 Each tablet contains Zolpidem Tartarate 10 mg (equiv. to Zolpidem 8,03 to Zolpidem 10 mg (equiv. Tartarate Each tablet contains Zolpidem Each film coated tablet contains Tamoxifen Citrate equiv. to tamoxifen Citrate equiv. Tamoxifen Each film coated tablet contains Tamoxifen to Citrate equiv. Tamoxifen Each film coated tablet contains Each film coated tablet contains Cefuroxime Axetil equiv. to Cefuroxime Cefuroxime to equiv. Axetil Cefuroxime contains tablet coated film Each Each tablet contains Amoxycillin Trihydrate equiv. to Amoxycillin Amoxycillin to equiv. Trihydrate Amoxycillin Each tablet contains Acid 125,0mg to Clavulanic equiv. 500,0mg, Potassium Clavulanate Amoxycillin to equiv. Trihydrate Amoxycillin Each tablet contains Acid 125,0mg to Clavulanic 850,0mg, Potassium Clavulanate equiv. STRENGTH/DOSE UNIT 125,0mg 10,0mg 20,0mg mg) 300,0 mg Each tablet contains Lamivudine 150,0 mg, Zidovudine Tablets Tablets Tablets Tablets Tablets Tablets Tablets DOSSAGE FORM Zolpidem Tartarate Tartarate Zolpidem Tamoxifen Citrate Tamoxifen Citrate Tamoxifen Amoxycillin Trihydrate, Trihydrate, Amoxycillin Trihydrate, Amoxycillin APPROVED NAME OF APPROVED NAME OF Axetil Cefuroxime Potassium Clavulanate Potassium Clavulanate Lamivudine / Zidovudine ACTIVE(S) Zolnoxs 10 mg Tablets Zolnoxs 10 mg Avocomb TamoxiHexal 10mg TamoxiHexal 20mg TamoxiHexal Curam 625 Curam 1000 REGISTERED NAME ZinnaHexal 125mg Tablets Ranbaxy (SA) (Pty) Ltd Aspen Pharmacare Sandoz (Pty) Limited Sandoz (Pty) Limited (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd Hexal Pharma (SA) (Pty) Ltd Hexal Pharma (SA) APPLICANT