GOVERNMENT GAZETTE OF THE REPUBLIC OF NAMIBIA. N$5.60 WINDHOEK - 31 July 2012 No. 5003

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1 GOVERNMENT GAZETTE OF THE REPUBLIC OF NAMIBIA N$5.60 WINDHOEK - 31 July 2012 No CONTENTS Page GOVERNMENT NOTICES No. 186 Cancellation of certain medicines: Medicines and Related Substances Control Act, No. 187 Exclusion of certain medicines from operation of certain regulations: Medicines and Related Substances Control Act, No. 188 Registration of certain medicines: Medicines and Related Substances Control Act, Government Notices MINISTRY OF HEALTH AND SOCIAL SERVICES No CANCELLATION OF CERTAIN MEDICINES: MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 2003 In term of section 23 of the Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003), I give notice of the cancellation of registration of the medicines set out in the Schedule below. J. GAESEB REGISTRAR OF MEDICINES Windhoek, 9 July 2012 SCHEDULE S/N HOLDER OF CERTIFICATE OF REGISTRATION PRORIETARY OF MEDICINE REGISTRATION NO. 1 Bayer Schering Pharma Fludara 04/26/ Bristol-Myers Squibb Videx 25 tablets 04/20.2.8/ Bristol-Myers Squibb Videx 50 tablets 04/20.2.8/1097

2 2 Government Gazette 31 July Bristol-Myers Squibb Videx 100 tablets 04/20.2.8/ Bristol-Myers Squibb Videx 150 tablets 04/20.2.8/ Bristol-Myers Squibb Videx Paediatric Powder 04/20.2.8/ Bristol-Myers Squibb Zerit 20 Capsules 04/20.2.8/ Bristol-Myers Squibb Zerit 30 Capsules 04/20.2.8/ Bristol-Myers Squibb Zerit 40 Capsules 04/20.2.8/ Bristol-Myers Squibb Zerit 1/mI Powder 04/20.2.8/ Janssen Pharmaceutica Acnidazil 90/23.12/ Janssen Pharmaceutica Acneclear Cream 04/13.12/ Janssen Pharmaceutica Tramal Suppositories 04/2.9/ Janssen Pharmaceutica Ortho-Est 04/21.8.1/ Janssen Pharmaceutica Eprex 2000/ml 04/30.4/ Janssen Pharmaceutica Reminyl 8 04/5.3/ Janssen Pharmaceutica Reminyl 4 04/5.3/ Janssen Pharmaceutica Reminyl 12 04/5.3/ Janssen Pharmaceutica Tinset 1/ml 04/5.7.1/ Ingelheim Pharmaceuticals Mobic 15 Suppository 04/3.1/ GlaxoSmithKline S.A Infanrix DTPa HB 04/30.1/ Bristol-Myers Squibb Videx EC /20.2.8/ Bristol-Myers Squibb Videx EC /20.2.8/ Bristol-Myers Squibb Reyalaz /20.2.6/ Bristol-Myers Squibb Reyalaz /20.2/ Pharmacare Limited Distalgesic Tablets 04/2.8/ Bayer Schering Pharma Noctamid Tablets 90/2.2/ Bayer Schering Pharma Primobolan S 90/21.6/ Eli Lilly (SA) (Pty) Limited Xigris 20 04/8/0667 MINISTRY OF HEALTH AND SOCIAL SERVICES No EXCLUSION OF CERTAIN MEDICINES FROM OPERATION OF CERTAIN REGULATIONS: MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 2003 In terms of section 45(1) of the Medicines and Related Substances Act, 2003 (Act No. 13 of 2003), after consultation with the Namibia Medicines Regulatory Council, I exclude the medicines referred to in Schedule 0, 1, 2, 3 and 4 of Government Notice No. 180 of 25 July 2008 from the operation of the following regulations, published under Government Notice No. 178 of 25 July 2008, for a period of 20 months from the date of publication of this notice: (a) (b) (c) (d) (e) 11(1)(b) and (l); 12(1)(a) and (w); 13(1)(a) and (j); 14(1)(c) and (1); and 15(1)(a) and (n). R.N. Kamwi Minister of Health and Social Services Windhoek, 7 July 2012

3 5003 Government Gazette 31 July MINISTRY OF HEALTH AND SOCIAL SERVICES No REGISTRATION OF CERTAIN MEDICINES: MEDICINES AND R ELATED SUBSTANCES CONTROL ACT, 2003 In terms of section 23 of the Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003), I give notice that the medicines set out in the Schedule have been registered in terms of that Act, subject to the following conditions: (a) (b) (c) the manufacture and control of the medicines must be in accordance with the existing current Good Manufacturing Practices as required by the World Health Organisation; in order to assess compliance with paragraph (a) inspections and investigations may be carried out regularly by inspectors authorised in terms of section 35 of the Act; the information in the package insert must, on a regular basis, be updated to conform with the package insert approved by the Council; (d) the holder of the certificate of registration which is referred to in subsection (7) of section 19 of the Act, must comply with the Act; (e) (f) (g) (h) the registration of 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; 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; a validation report must be submitted to the Council within one month from the date of completion of the validation referred to in paragraph (e) ; and the Council may review the registration dossier at such intervals as the Council may determine. J. Gaeseb REGISTRAR OF MEDICINES Windhoek, 9 July 2012

4 4 Government Gazette 31 July SCHEDULE APPROVED 1 Adcock Ingram Limited Adco-Meloxicam 7.5 Meloxicam Tablet Each tablet contains Meloxicam 7,5 12/3.1/ NS 2 2 Adcock Ingram Limited Adco-Meloxicam 15 Meloxicam Tablet Each tablet contains Meloxicam 15,0 3 GlaxoSmithKline South Africa(Pty) 4 Bodene Hyoscine butylbromide Fresenius 20 /ml Paxil 20 Paroxetine Hydrochloride Hyoscine Butylbromide 5 Adcock Ingram Limited Stresam Etifoxine Hydrochloride Tablet Each tablet contains Paroxetine hydrochloride equivalent to Paroxetine 20,0 Injection Each 1.0 ml solution contains Hyoscine Butylbromide 20,0 Capsule Each capsule contains Etifoxine hydrochloride Butylbromide 50,0 6 Bayer Xarelto 15 Rivaroxaban Tablet Each film coated tablet contains Rivaroxaban 15,0 7 Bayer Xarelto 20 Rivaroxaban Tablet Each film-coated tablet contains Rivaroxaban Biotech Laboratories (Pty) 9 Biotech Laboratories(Pty) 10 Biotech Laboratories (Pty) 11 Biotech Laboratories (Pty) Penilente L.A 2,4 MU Pentlente L.A 1,2 MU Benzathine Benzyl- Penicillin Benzathine Benzyl- Penicillin Injection Each vial of 8ml suspension buffered Benthazine Benzyl-Penicillin equivalent to Benthazine Benzyl-Penicillin 2,400,000 IU Injection Each vial of 4ml suspension contains Buffered Benthazine Benzyl-Penicillin equiv to Benthazine Benzyl-Penicillin 1,200,000 IU 12/3.1/ NS 2 12/1.2/ NS 3 12/11.2/ NS 2 12/2.6/ NS 3 12/8.2/ NS 2 12/8.2/ NS 2 12/20.1.2/ NS2 12/20.1.2/ NS2 Bio-Atenolol 50 Atenolol Tablet Each tablet contains Antenolol 50 12/5.2/ NS 2 Bio- Cimetidine 200 Cimetidine Tablet Each film-coated tablet contains Cimetidine 200,0 12/11.4.3/ NS 2

5 5003 Government Gazette 31 July Biotech Laboratories (Pty) 13 Biotech Laboratories (Pty) 14 Be-Tabs Pharmaceuticals (Pty) Bio-Cimetidine 400 APPROVED Cimetidine Tablet Each Film coated tablet contains Cimetidine 400,0 12/11.4.3/ NS 2 Bio-Sulpiride 200 Sulpiride Tablet Each tablet contains Sulpiride 200,0 12/2.6.5/ NS 3 Betaprofen 400 FC Ibuprofen Tablet Each film coated tablet contains Ibuprofen /3.1/ NS 2 15 Be-Tabs Pharmaceuticals Bedoral 30 Ketorrolac Tromethamine Injection Each 1 ml ampoule contains Ketorrolac Tramethamine 30,0 16 Pharmafrica (Pty) Tranic Tranexamic Acid Tablet Each Tablet contains Tranexamic Acid Astrazeneca Pharmaceuticals (Pty) Nexiam 10 Sachets 18 Pharmacare Limited Tellerge Tablets 180 Fexofenadine Hydrochloride 19 Pharmacare Limited Tellerge Tablets 120 Fexofenadine Hydrochloride 20 Novartis (SA) Esomeprazole Sachet Each Sachet contains Esomeprazole 10,0 Tablet Each Tablet contains Fexofenadine Hydrochloride 120 Tablet Each tablet contains Fexofenadine Hydrochloride /2.7/ NS 2 12/8.1/ NS 2 12/11.4.3/ NS 2 12/5.7.1/ NS 1 12/5.7.1/ NS 1 Migroben 80 Tablet Valsartan Tablet Each tablet contains Valsartan /7.1.3/ NS 2 21 Novartis (SA) (Pty) Microben 80 Tablet Valsartan Tablet Each Tablet contains Valsartan 160,0 12/7.1/ NS 2 22 Novartis (SA) (Pty) Zomevek 80 Tablet Valsartan Tablet Each tablet contains Valsartan 80,0 12/7.1.3/ NS 2 23 Novartis (SA) (Pty) Zomevek 160 Tablet Valsartan Tablet Each Tablet contains Valsartan /7.1.3/ NS 2 12/7.1.3/ NS 2 24 Novartis (SA) (Pty) Co-Migroben 80 Tablet 25 Novartis (SA) (Pty) Co-Migroben160 Tablet 26 Novartis (SA) (Pty) Co-Migoben 160 Plus 27 Novartis (SA) (Pty) Co-Zamevek 80 Tablets 28 Novartis (SA) (Pty) Co-Zomevek 160 Plus tablets Valsartan, Hydrochlorothiazide Valsartan, Hydrochlorothiazide Valsartan, Hydrochlorothiazide Valsartan, Hydrochlorothiazide Valsartan, Hydrochlorothiazide Tablet Each tablet contains Valsartan 80,0 Hydrochlorothiazide 12,5 Tablet Each Tablet contains Valsartan 160,0 Hydrochlorothiazide 12,5 Tablet Each tablet contains Valsartan 160,0, Hydrochlorothiazide 25,0 Tablet Each tablet contains Valsartan 80,0, Hydrochlorothiazide 12,5 Tablet Each Tabet contains Valsartan 160,0, Hydrochlorothiazide 12,5 12/7.1.3/ NS 2 12/7.1.3/ NS 2 12/7.1.3/ NS 2 12/7.1.3/ NS 2

6 6 Government Gazette 31 July Novartis (SA) (Pty) Co-Zomevek 160 tablets APPROVED Valsartan, Hydrochlothiazide 30 Novartis (SA) Tasigna 200 Nilotinib Hydrochloride Tablet Each tablet contains Valsartan 160,0, Hydrochlorothiazide 25,0 Capsule Each capsule contains Nilotinib Hydrochloride Monohydrate equivalent to Nilitinib base Merck S.A (Pty) Fixime Tablets Cefixime Tablet Each coated tablet contains Cefixime MSD(Pty) Zocer 10 tablets Simvastatin Tablets Each film-coated tablet contains simvastatin 10,0 33 MSD Zocor 20 tablets Simvastatin Tablets Each film-coated tablet contains Simvastatin 20,0 34 Pharma Dynamics (Pty) 35 Pharma Dynamics (Pty) 36 Alcon Laboratories (SA) 37 Alcon Laboratories (SA) 38 Alcon Laboratories (SA) Actamax 5 Risedronic Sodium Hemipentahydrate Actamax 35 Risedronic Sodium Hemipentahydrate Tobradex Eye Suspension Iodipine 1% Unit Dose Tobralex Eye Ointment Dexamethasone, Tobtamycin Apraclonidine Hydrochloride Dexamethasone, Tobtamycin Tablets Each film-coated tablet contains Risedronic Sodium Hemipentahydrate equivalent to Risedronate Sodium 5,0 Tablets Each film-coated tablet contains Risedronic Sodium Hemipentahydrate equivalent to Risedronate Sodium 35,0 Opthalmic Suspension Opthalmic Solution Opthalmic Ointment 39 MSD Cancidas 70 Caspofungin Acetate Powder for Infusion Each 1ml suspension contains Dexamethasone 1,0, Tobramycin 3,0 Each 1 ml solution contains Apraclonidine Hydrochloride equiv. to Apraclonidine 10,0 Each g ointment contains Dexamethasone 1,0, Tobramycin 3,0 Each vial contains: caspofungin Acetate equivalent to Caspofungin 70,0 12/7.1.3/ NS 2 12/26/ NS 2 12/20.1.1/ NS 2 12/7.5/ NS 2 12/7.5/ NS2 12/7.5/ NS2 12/3.2/ NS2 12/15.3/ NS2 12/15.4/ NS2 12/15.3/ NS2 12/20.2.2/ NS2 40 MSD Cancidas 50 Caspofungin Acetate Powder for Infusion Each vial contains: caspofungin Acetate equivalent to Caspofungin 50,0 12/20.2.2/ NS2 41 Activo Health Acti-Tran 0,5 Capsules Trandolapril Capsule Each capsule contains Trandolapril 0,5 12/7.1.3/ NS2

7 5003 Government Gazette 31 July Activo Health Acti-Tran 2 Capsules 43 Activo Health Acti-Tran 4 Capsules 44 Adcock Ingram Limited Adco - Covospor Vaginal 45 Adcock Ingram Limited Adco Lamivudine and Zidovudine 46 Winthrop Pharmaceuticals 150/300 Levofloxacin Winthrop I.V Winthrop Pharmaceuticals Levofloxacin Winthrop I.V GlaxoSmithKline South Africa 49 GlaxoSmithKline South Africa Med-Lemon Wet Cough Syrup Med-Lemon Hot Medication with Vitamin-C 50 GlaxoSmithKline South Africa 51 GlaxoSmithKline South Africa Med-lemon Flu & Congestion Hot Medication with Vitamin C Eno Active Fruit Salt - Apple 52 GlaxoSmithKline South Africa Eno Active Fruit Salt - Lemon APPROVED Trandolapril Capsule Each capsule contains Trandolapril 2,0 Trandolapril Capsule Each capsule contains Trandolapril 4,0 Clotrimazole Vaginal cream Lamivudine, Zidovudine Each 1 g of cream contains clotrimazole 10 Tablets Each tablet contains Lamivudine 150,0, Zidovudine 300,0 12/7.1.3/ NS2 12/7.1.3/ NS2 12/20.2.2/ NS1 12/20.2.8/ NS2 Levofloxacin hemihydrate Levofloxacin hemihydrate Injection Each 50 ml vial solution for infusion contains Levofloxacin hemihydrate equivalent to Levofloxacin 250 Injection Each 100 ml vial solution for infusion contains Levofloxacin hemihydrate equivalent to Levofloxacin 500 Guaiphenesin Syrup Each 10 ml syrup contains Guaiphenesin 100 Combination Powder / sachet Combination Powder / sachet Each sachet contains aspirin 800, caffeine anhydrous 50, ascorbic acid 45 and menthol polvaromans 14,40 Each sachet contains Phenylephrine HCl 10,0, Paracetamol 600,0, Ascorbic acid 40,0 12/20.1.1/ NS2 12/20.1.1/ NS2 12/10.1/ NS0 12/5.8/ NS0 12/5.8/ NS1 Combination Powder / sachet Combination Powder / sachet Each 5,0 g dose contains sodium bicarbonate 2,32g ; anhydrous citric acid 2,18 g and sodium carbonate 0,50g Each 5,0 g contains sodium bicarbonate 2,29g; anhydrous citric acid 2,16 g and sodium carbonate 0,50 12/11.4/ NS0 12/11.4/ NS0

8 8 Government Gazette 31 July GlaxoSmithKline South Africa 54 GlaxoSmithKline South Africa Eno Active Fruit Salt - Orange Eno Active Fruit Salt - Regular 55 Adcock Ingram Limited Adco-Quinaretic 10/12,5 56 Adcock Ingram Limited Dilinct Dry Cough Syrup 57 Pfizer Laboratories 58 Pharma Dynamics (Pty) 59 abbott Laboratories SA APPROVED Combination Powder / sachet Combination Powder / sachet Quinapril Hydrochloride / Hydrochlorothiazide Dextromethorphan Hydrobromide Each 5,0 g dose contains sodium bicarbonate 2,29 g, anhydrous citric acid 2,16 g and sodium carbonate 0,50 g Each 5,0 g dose contains sodium bicarbonate 2,29 g, anhydrous citric acid 2,16 g and sodium carbonate 0,50 g Tablet Each tablet contains Quinapril Hydrochloride equiv. to Quinapril 10,0, Hydrochlorothiazide 12,5 Syrup Each 5 ml syrup contains Dextromethorphan Hydrobromide 15,0 Advil Liqui-Gels Ibuprofen Capsule Each capsule contains Ibuprofen 200,0 Dyna Cefpodoxime Cipla-Medpro Cipla-Irinotecan 100/5ml 61 Cipla-Medpro Cipla-Irinotecan 40/2ml Cefpodoxime Proxetil Tablets Each tablet contains: Cefpodoxime Proxetil equiv. to Cefpodoxime 100,0 PreceDEX Dexmedetomidine Concentrate for Infusion Irinotecan Solution for Infusion Irinotecan Solution for Infusion Each 1 ml solution contains Dexmedetomidine 100 µg Each 1ml solution contains; Irinotecan Hydrochloride Trihydarte 20,0 Each 1ml solution contains; Irinotecan Hydrochloride Trihydarte 20,0 62 Cipla-Medpro Bicadex Bicalutamide Tablet Each film coated tablet contains Bicalutamide 50,0 63 Sandoz SA Sandoz Alendronate 70 Sodium Alendronate Tablet Each tablet contains Alendronate sodium equiv. to Alendronic Acid 70,0 12/11/4/ NS0 12/11.4/ NS0 12/7.1.3/ NS2 12/10.1/ NS1 12/2.7/ NS1 12/20.1.1/ NS2 12/2.9/ NS3 12/26/ NS2 12/26/ NS2 12/21.12/ NS2 12/3.2/ NS2 64 Sandoz SA Ostomir 70 Sodium Alendronate Tablet Each tablet contains Alendronate sodium equivalent to Alendronic Acid 70,0 12/3.2/ NS2

9 5003 Government Gazette 31 July APPROVED 65 Sandoz SA Ibupain Combination Capsule Each capsule contains: Ibuprofen 200,0, Paracetamol 250,0 66 Ingelheim Pharmaceuticals 67 Ingelheim Pharmaceuticals Micace 5 Ramipril Tablet Each uncoated tablet contains Ramipril 5,0 Micace 10 Ramipril Tablet Each uncoated tablet contains Ramipril 10,0 68 Pharmacare Limited Risonel 35 Risedronate Sodium Tablet Each film-coated tablet contains Risedronic Sodium Hemipentahydrate equivalent to Risedronate Sodium 35,0 69 Pharmacare Limited Risonel 5 Risedronate Sodium Tablet Each film-coated tablet contains Risedronic Sodium Hemipentahydrate equivalent to Risedronate Sodium 5,0 70 Pharma Dynamics (Pty) 71 Pharma Dynamics (Pty) Zartan Co 50/12,5 Losartan Potassium, Hydrocholothiazide Zartan Co 100/25 Losartan Potassium, Hydrocholothiazide Tablet Each tablet contains Losartan Potassium equivalent to Losartan 50 and Hydrochlorothiazide 12,5 Tablet Each tablet contains Losartan Potassium equivalent to losartan 100 and Hydrochlorothiazide Sandoz SA Migrex 100 Sumatriptan Tablet Each tablet contains Sumatriptan Succinate equivalent to Sumatriptan 100,0 73 Sandoz SA Migrex 50 Sumatriptan Tablet Each tablet contains Sumatriptan Succinate equivalent to Sumatriptan 50,0 74 Sandoz SA Sandoz K600 Potassium Chloride Tablet Each sugar coated tablet contains Potassium Chloride 600,0 75 Sandoz SA Sandoz Ceftriaxone 2.0 g 76 Sandoz SA Sandoz Ceftriaxone 1.0 g 77 Sandoz SA Sandoz Ceftriaxone 0.5 g 78 AstraZeneca Pharmaceuticals Ceftriaxone Sodium Injection Each vial contains Ceftriaxone Sodium equivalent to Ceftriaxone 2,0 g Ceftriaxone Sodium Injection Each vial contains Ceftriaxone Sodium equivalent to Ceftriaxone 1,0 g Ceftriaxone Sodium Injection Each vial contains Ceftriaxone Sodium equivalent to Ceftriaxone 0,5 g Atacand 32 Candesartan Cilexetil Tablet Each tablet contains Candesartan Cilexetil /2.8/ NS1 12/7.1.3/ NS2 12/3.2/ NS2 12/3.2/ NS2 12/3.2/ NS2 12/7.1.3/ NS2 12/7..1.3/ NS2 12/7.3/ NS2 12/7.3/ NS2 12/24/ NS1 12/20.1.1/ NS2 12/20.1.1/ NS2 12/20.1.1/ NS2 12/7.1.3/ NS2

10 10 Government Gazette 31 July AstraZeneca Pharmaceuticals 80 AstraZeneca Pharmaceuticals Atacand Plus 32 /12.5 APPROVED Candesartan Cilexetil, Hydrochlorothiazide Atacand Plus 32 /25 Candesartan Cilexetil, Hydrochlorothiazide Tablet Each tablet contains Candesartan Cilexetil Hydrochlorothiazide 12.5 Tablet Each tablet contains Candesartan Cilexetil 32.0, Hydrochlorothiazide 25 12/7.1.3/ NS2 12/7.1.3/ NS2 81 Adcock Ingram Limited Adco-Abacavir Abacavir Sulphate Tablet Each tablet contains Abacavir sulphate equivalent to Abacavir 300,0 82 Adcock Ingram Limited Adco-Emtevir Amtricitabine, Tenofovir disoproxil Fumarate Tablet Each tablet contains Emtricitabine 200,0, Tenofovir Disoproxil Fumarate 300,0 83 Pharmacare Limited Nitepax Suspension Noscapine Suspension Each 5 ml suspension contains noscapine resin complex equivalent to Noscapine Ranbaxy (S.A.) Casoprost 150 Bicalutamide Tablet Each film-coated tablet contains Bicalutamide 150,0 85 Ranbaxy (S.A.) Casoprost 50 Bicalutamide Tablet Each film-coated tablet contains Bicalutamide 50,0 86 Ranbaxy (S.A.) Ran-Pravastatin 40 Pravastatin Sodium Tablet Each tablet contains Pravastatin Sodium 40,0 87 Ranbaxy (S.A.) Ran-Pravastatin 20 Pravastatin Sodium Tablet Each tablet contains Pravastatin Sodium 20,0 88 Ranbaxy (S.A.) Ran-Pravastatin 10 Pravastatin Sodium Tablet Each tablet contains Pravastatin Sodium 10,0 89 Sandoz SA Tramahexal SR 100 Tramadol Hydrochloride 90 Sandoz SA Tramahexal SR 150 Tramadol Hydrochloride 91 Sandoz SA Tramahexal SR 200 Tramadol Hydrochloride Tablet Each modified release tablet contains Tramadol Hydrochloride 100,0 Tablet Each modified release tablet contains Tramadol Hydrochloride 150,0 Tablet Each modified release tablet contains Tramadol Hydrochloride 200,0 12/20.2.8/ NS2 12/20.2.8/ NS2 12/10.1/ NS1 12/21.12/ NS2 12/21.12/ NS2 12/7.5/ NS2 12/7.5/ NS2 12/7.5/ NS2 12/2.9/ NS3 12/2.9/ NS3 12/2.9/ NS3

11 5003 Government Gazette 31 July APPROVED 92 Sandoz SA Cefu-Hexal 250 Cefuroxime Axetil Tablet Each film-coated tablet contains Cefuroxime Axetil equivalent to Cefuroxime 250,0 94 Sandoz SA Terbane 250 Terbinafine Hydrochloride 95 Adcock Ingram Limited Gripon Cold and Flu Tablets 96 Pfizer Laboratories (Pty) 97 Pfizer Laboratories 98 Pfizer Laboratories 93 Sandoz SA Cefu-Hexal 500 Cefuroxime Axetil Tablet Each film-coated tablet contains Cefuroxime Axetil equivalent to Cefuroxime 250,0 Tablet Each tablet contains Terbinafine Hydrochloride equivalent to Terbinafine 250,0 Combination Tablet Each tablet contains; Phenylephrine Hydrochloride 5,0, Chlorpheniramine Maleate 2,0, Paracetamol 150,0, Caffein Anhydrous 15,0 Champix 0.5 Varenicline Tatrate Tablet Each tablet contains Varenicline Tatrate equivalent to Varencline 0.5 Champix 1.0 Varenicline Tatrate Tablet Each tablet contains Varenicline Tatrate equivalent to Varencline 1.0 Advil-Liqui-Gels 400 Ibuprofen Capsule Each liquid-gel capsule contains Ibuprofen 400,0 99 Pharmafrica Oculet Providone Eye drops Each 1ml solution contains Povidone 20,0 100 Milan Laboratories (India) 101 Milan Laboratories (India) 102 Milan Laboratories (India) Pty 103 Milan Laboratories (India) Pty 104 Milan Laboratories (India) Pty ML-Cotri Suspension Sulphamethoxale, Trimethoprim Milmaleate Tablets Chlorpheniramine Maleate Metro Forte Suspension Metronidazole Tablets BP 400 Cloxacillin Capsules USP 250 Metronidazole Benzoate Suspension Each 5 ml suspension contains Sulphamethoxazole 220,0, Trimethoprim 40,0 Tablets Each uncoated tablet contains Chlorpheniramine Maleate 4,0 Suspension Each 5ml suspension contains Metronidazole Benzoate equivalent to Metronidazole 200,0 Metronidazole Tablets Each sugar coated tablet contains Metronidazole BP 400,0 Cloxacillin Sodium Capsules Each capsule contains Cloxacillin 250,0 12/20.1.1/ NS2 12/20.1.1/ NS2 12/20.2.2/ NS2 12/5.8/ NS1 12/34/ NS 2 12/34/ NS 2 12/2.7/ NS 1 12/15.4/ NS 0 12/20.2/ NS 2 12/5.7/ NS 1 12/20.2.6/ NS 2 12/20.2.6/ NS 2 12/20.1.2/ NS 2

12 12 Government Gazette 31 July Milan Laboratories (India) 105 Pty 106 Milan Laboratories (India) Pty 107 Milan Laboratories (India) Pty APPROVED Bertrim-480 Sulphamethoxazole, Trimethoprim Phenoxymethylpenicillin Oral Solution lin Potassium Phenoxymethylpenicil- 250 / 5ml Phenoxymethylpenicillin oral Solution 125 / 5ml Phenoxymethylpenicillin Potassium 109 Oshakati Pharmacy Tensopyn Paediatric Syrup 110 Pharma Dynamics (Pty) Dyna Gliclazide SR Cipla-Medpro Cipla-Paclitaxel 100 / 16.7 ml 112 Cipla-Medpro Cipla- Paclitaxel 30 / 15 ml Paclitaxel 113 Cipla-Medpro Cipla-Paclitaxel 300/ Cipla-Medpro Alkafizz Effervescent Granules 108 Cipla-Mepro Odimune Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Paracetamol, Codeine Phosphate Tablets Each tablet contains Sulphamethoxazole 400,0, Trimethoprim 80,0 Powder for reconstitution Powder for reconstitution Each 5 ml of reconstituted solution contains Phenoxylmethylpenicillin Potasssium BP equivalent to Phenoxymethylpenicillin 250,0 Each 5 ml of reconstituted solution contains Phenoxymethylpenicillin Potassium BP equivalent to Phenoxymethylpenicillin 125,0 Tablets Each tablet contains Efavirenz 600,0. Emtricitabine 200,0, Tenofovir Disoproxil Fumarate 300,0 Syrup Each 5ml syrup contains; Paracetamol 150,0, Codeine Phosphate 4,0 Gliclazide Tablets Each modified release tablet contains Gliclazide 30,0 Paclitaxel Injection Each single dose vial (16.7) ml contains Paclitaxel 100,0 Injection Each single dose vial (5ml) contains Paclitaxel 30,0 Paclitaxel Injection Each single does vial (50 ml) contains Paclitaxel 300,0 Combination Granules Each medicine measure (4g) contains; Sodium Citrate g, Sodium bicarbonate 1,716 g, Citric Acid Anhydrous 0,702 g, Tartaric Acid g 115 Cipla- Medpro Cipla Docetaxel 80 Docetaxel Trihydrate Injection Each vial contains Docetaxel Trihydrate equivalent to Docetaxel (anhydrous) 80,0 116 Cipla-Medpro Solvent for Cipla Docetaxel 80 12/20.2/ NS 2 12/20.1.2/ NS 2 12/20.1.2/ NS 2 12/20.2.8/ NS2 12/21.2/ NS 1 12/21.2/ NS 2 12/26/ NS2 12/26/ NS 2 12/26/ NS 2 12/18.3/ NS 0 12/26/ NS 2 Ethanol 13,0 % m/v Injection Each vial contains Ethanol 13,0% 12/32.2/ NS 1

13 5003 Government Gazette 31 July APPROVED 117 Cipla-medpro Cipla Docetaxel 20 Docetaxel Trihydrate Injection Each vial contains Docetaxel Trihydrate equivalent to Docetaxel (anhydrous) 20,0 118 Cipla- Medpro Solvent for Cipla Docetaxel 20 12/26/ NS 2 Ethanol 13,0% m/v Injection Each vial contains Ethanol 13,0% m/v 12/32.2/ NS Roche Products CellCept Mycophenolate Mofetil Capsules Each capsule contains Mycophenolate Mofetil 250,0 120 Roche Products CellCept 500 Mycophenolate Mofetil Tablets Each film-coated tablet contains Mycophenolate Mofetil 500,0 121 Adcock Ingram Aco-Lamivudine 300 tablets 122 Janssen Pharmaceutica 123 Meyerzell Laboratories Topamax SC 15 Lamivudine Tablets Each tablet contains Lamivudine 300,0 Topiramate Capsules Each capsule contains Topiramate 15 Covarex Cream Miconazole Nitrate Cream Each 1 g cream contains Micronazole Nitrate 20,0 12/34/ NS 2 12/34/ NS 2 12/20.2.8/ NS 2 12/2.5/ NS 2 12/13.9.2/ NS1 124 Adcock Ingram Adco-Mirteron 30 Mirtazapine Tablets Each Tablet contains Mirtazapine 30 12/1.2/ NS Adco Ingram Adco Mirteron 15 Mirtazapine Tablets Each Tablet contains Mirtazapine 15,0 12/1.2/ NS Novartis SA Exforge 5/320 Amlodipine Besylate, Valsartan 127 Novartis SA Exforge 10/320 Amlodipine Besylate, Valsartan 128 Novartis SA Galvus Met 50/850 Vildagliptin, Metformin 129 Novartis SA Galvus Met 50/100 Vildagliptin, Metformin 130 Sandos SA Hexal-MPA 5 Medroxyprogesterone Acetate 131 Sandos SA Hexal- MPA 10 Medroxyprogesterone Acetate Tablets Each tablt contains Amlodipine Besylate equivalent to Amlodipine 5,0 Valsartan 320,0 Tablets Each tablet contains Amlodipine Besylate equivalent to Amlodipine 10,0, Valsartan 320,0 Tablets Each tablet contains Vildagliptin 50,0 ; Metformin 850,0 Tablets Each tablet contains Vildagliptin 50,0 ; Metformin 850,0 Tablets Each tablet contains Medroxyprogesterone Acetate 5,0 Tablets Each tablet contains Medroxyprogesterone Acetate 10,0 12/7.1.3/ NS2 12/7.1.3/ NS 2 12/21.2/ NS 2 12/21.2/ NS 2 12/21.8.2/ NS 2 12/21.8.2/ NS 2

14 14 Government Gazette 31 July Sandos SA Fluvoxamine-Hexal Sandos SA Cetirizine-Hexal 1 / ml Oral Solution 134 Sandos SA Cetirizine-Hexal 10 APPROVED Fluvoxamine Maleate Tablets Each film-coated tablet contains Fluvoxamine Maleate 100,0 Cetirizine Dihyrochloride Cetirizine Dihydrochloride Solution Each 1 ml Oral Solution contains Cetirizine Dihydrochloride 1,0 Tablets Each film coated tablet contains Cetirizine Dihydrochloride 10,0 135 Sandos SA BisHexal 5 Bisoprolol Fumarate Tablets Each film coated tablet contains Bisoprolol Fumarate 5,0 136 Sandos SA BisoHexal 10 Bisoprolol Furmarate Tablets Each film coated tablet contains Bisoprolol Furmarate 10,0 137 Adcock Ingram Nebilet 5 Nebivolol Hydrochloride 138 Pharma Dynamics Tablets Each tablet contains Nebivolol Hydrochloride equivalent to Nebivolol 5,0 Dyna Indapamide SR Indapamide Tablets Each sustained release tablet contains Indapamide 1,5 12/1.2/ NS 3 12/5.7/ NS 1 12/5.7/ NS 1 12/5.2/ NS 2 12/5.2/ NS2 12/7.1.3/ NS 2 12/7.1/ NS 2