GOVERNMENT GAZETTE OF THE REPUBLIC OF NAMIBIA N$4.00 WINDHOEK - 14 August 2013 No. 5263 CONTENTS Page GOVERNMENT NOTICES No. 211 No. 212 Request for submission of name of pharmacist for nomination for appointment of member of Namibia Medicines Regulatory Council: Medicines and Related Substances Control Act, 2003... 1 Notification of registration of certain medicines: Medicines and Related Substances Control Act, 2003... 2 Government Notices MINISTRY OF HEALTH AND SOCIAL SERVICES No. 211 2013 REQUEST FOR SUBMISSION OF NAME OF PHARMACIST FOR NOMINATION FOR APPOINTMENT AS MEMBER OF NAMIBIA MEDICINES REGULATORY COUNCIL: MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 2003 In terms of section 3(2) of the Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003), I request any interested body to submit, within 30 days from the date of this notice in the Gazette, the name of a suitably qualified pharmacist for nomination for appointment as a member of the Namibia Medicines Regulatory Council in terms of subsection (1)(b)(ii) of that section. R. Kamwi Minister of Health and Social Services Windhoek, 22 July 2013
2 Government Gazette 14 August 2013 5263 MINISTRY OF HEALTH AND SOCIAL SERVICES No. 212 2013 NOTIFICATION OF REGISTRATION OF CERTAIN MEDICINES: MEDICINES AND RELATED 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) (d) (e) (f) (g) (h) 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), an inspection or investigation may be carried out regularly by an inspector 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 Namibia Medicines Regulatory Council; the holder of the certificate of registration referred to in section 19(7) of the Medicines and Related Substance Control Act, 2003 must comply with the provisions of that Act; the registration of medicine is subject to regular review regarding its quality, safety and efficacy and the Namibia Medicines Regulatory 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 application for registration; a validation report must be submitted to the Namibia Medicines Regulatory Council within one month from the date of completion of the validation referred in paragraph (f); and the Namibia Medicines Regulatory Council may review the registration dossier at such intervals as the Council may determine. J. GAESEB REGISTRAR OF MEDICINES Windhoek, 22 July 2013 SCHEDULE S/N APPLICANT PROPRIETARY NAME 1 2 3 4 APPROVED NAME OF ACTIVE(S) REGIST. NO. Teva-Fludarabine 50 Fludarabine Phosphate 13/26/0001 Teva-Vinorelbine 10 mg Infusion Teva-Bicalutamide 50 mg Tablet Teva-Bicalutamide 150 mg Tablet 5 MSD Sinemet 25/100 Vinorelbine Tartrate 13/26/0002 Bicalutamide 13/21.12/0003 Bicalutamide 13/21.12/0004 Carbidopa Monohydrate, Levodopa 13/5.4.1/0005
5263 Government Gazette 14 August 2013 3 6 MSD Sinemet 25/250 Carbidopa Monohydrate, Levodopa 13/5.4.1/0006 7 MSD Timoptol 0,25% Opthalmic Solution Timoptol Maleate 13/15.4/0007 8 MSD Timoptol XE 0,25% Timoptol Maleate 13/15.4/0008 9 MSD Timoptol XE 0,5% Timoptol Maleate 13/15.4/0009 10 MSD Inegy 10/10 Ezetimibe, Simvastatin 13/7.5/0010 11 MSD Inegy 10/20 Ezetimibe, Simvastatin 13/7.5/0011 12 MSD Inegy 10/40 Ezetimibe, Simvastatin 13/7.5/00012 13 MSD Zocor 40 Simvastatin 13/7.5/0013 14 MSD Trusopt 2% Dorsolamide 13/15.4/0014 15 Hetero Labs Giagra-25 mg Sildenafil Citrate 13/7.1.5/0015 16 Hetero Labs Giagra-50 mg Sildenafil Citrate 13/7.1.5/0016 17 Hetero Labs Giagra-100 mg Sildenafil Citrate 13/7.1.5/0017 18 Devacort Cream Hydrocortisone 13/13.4.1/0018 19 20 21 22 23 24 25 26 27 28 29 30 Serum Institute of India Serum Institute of India Adcock Ingram Micort Hydrocortisone, Miconazole 13/13.4.1/0019 Abitrexate 2.5 mg Methotrexate 13/26/0020 Abitrexate 5 g Methotrexate 13/26/0021 Abitrexate 500 Methotrexate 13/26/0022 MR Vaccine Measles, Rubella 13/30.3/0023 Pentavalent Vaccine, Liquid DPT, HBs, Haemophilus influenza Vaccine 13/30.3/0024 Abitrexate 50 Methotrexate 13/26/0025 Teva Carbi-Levo 25/100 Teva Carbi-Levo 25/250 Carbidopa Monohydrate, Levodopa Carbidopa Monohydrate, Levodopa 13/5.4.1/0026 13/5.4.1/0027 Tamoplex 20 mg Tamoxifen Citrate 13/21.12/0028 Teva Baclofen 10 Baclofen 13/2.10/0029 Allergex Eye Drops 31 Co-Rampil 5/25 32 33 34 35 (SA) (SA) (SA) (SA) Zofer Rapitab 4 Zofer Rapitab 8 Oxymetazoline Ramipril, Hydrochllorothiazide Ondansetron Ondansetron 13/15.4/0030 13/7.1.3/0031 13/5.10/0032 13/5.10.0033 Metored 500 Metformin 13/21.2/0034 Metored 850 Metformin 13/24.2/0035
4 Government Gazette 14 August 2013 5263 36 (SA) 37 (SA) 38 39 Sandoz SA Cetirizine-Hexal l0.0mg/ml Oral Drops Solution Metored 1000 Metformin 13/21.2/0036 Pantocid 40 Pantoprazole Sodium 13/11.4.3/0037 Febramol Paracetamol 13/2.7/0038 Cetirizine Dihydrochloride 13/5.7.1/0039 40 Sandoz SA Risperidone Hexal 0,5 Risperidone 13/2.6.5/0040 41 Micovar Oral Gel Miconazole 13/20.2.2/0041 42 Novo Nordisk Pharma Gulf FZ-LLC Victoza Liraglutide 13/21.13/0042 43 Sandoz SA Sandoz Vinorelbine 50mg/5ml Vinorelbine Tartarate 13/26/0043 44 Sandoz SA Sandoz Vinorelbine 10 mg/1ml IVI Vinorelbine Tartarate 13/26/0044 45 Sandoz SA Losartan Hexal 50 Losartan Potassium 13/7.1.3/0045 46 Sandoz SA Los-ARB 50 Losartan Potassium 13/7.1.3/0046 47 Winthrop Pharmaceuticals (Pty) Irbewin 300 mg Irbesartan 13/7.1.3/0047 48 Winthrop Pharmaceuticals (Pty) Irbewin 150 mg Irbesartan 13/7.1.3/0048 49 50 Winthrop Pharmaceuticals (Pty) Winthrop Pharmaceuticals (Pty) 51 Sandoz SA Galantic 4 52 Sandoz SA Galantic 8 Co-Irbewin 300/12,5 Co-Irbewin 150/12,5 53 Sandoz SA Galantic 12 54 Sandoz SA Sandoz 4 55 Sandoz SA Sandoz 8 56 Sandoz SA Sandoz 12 57 Sandoz SA Hexal Gemcitabine 200 IVI 58 Sandoz SA Hexal Gemcitabine 1g IVI 59 Sandoz SA Sandoz Gemcitabine 200 IVI 60 Sandoz SA Sandoz Gemcitabine 1g IVI 61 Sandoz SA Hx-Mitoxantrone 20mg/10ml Irbesartan, Hydrchlorothiazide Irbesartan, Hydrochiorothiazide Gemcitabine Gemcitabine Gemcitabine Gemcitabine Mitoxantron 13/7.1.3/0049 13/7.1.3/0050 13/5.3/0051 13/5.3/0052 13/5.3/0053 13/5.3.10054 13/5.3/0055 13/5.3/0056 13/26/0057 13/26/0058 13/26/0059 13/26/0060 13/26/0061
5263 Government Gazette 14 August 2013 5 62 Sandoz SA Mitoxantrone-Hexal 20mg/10ml Mitoxantron 13/26/0062 63 Sandoz SA Clarihexal 500 Tablets Clarithromycin 13/20.1.1/0063 64 Sandoz SA Anastrozole Sandoz 1 Anastrozole 13/21.12/0064 65 (SA) Pty Trobalt 50 Retigabine 13/2.5/0065 66 (SA) Pty Trobalt 100 Retigabine 13/2.5/0066 67 (SA) Pty Trobalt 200 Retigabine 13/2.5/0067 68 (SA) Pty Trobalt 300 Retigabine 13/2.5/0068 69 (SA) Pty Trobalt 400 Retigabine 13/2.5/0069 70 and Pharmaceuticals Cloxabiotic 250 Cloxacillin Sodium 13/20.1.1/0070 71 and Pharmaceuticals Cloxabiotic 500 Cloxacillin Sodium 13/20.1.1/0071 72 and Pharmaceuticals Kampibiotic 250 Ampicillin Sodium 13/20.1.1/0072 73 and Pharmaceuticals Kampibiotic 500 Ampicillin Sodium 13/20.1.1/0073 74 and Pharmaceuticals Ruxim 750 Cefuroxime Sodium 13/20.1.1/0074 75 and Pharmaceuticals Bepen 10 Benzylpenicillin Sodium 13/20.1.1/0075 76 and Pharmaceuticals Benzapen 2.4 Penicillin G Benzathine 13/20.1.1/0076 77 78 79 80 and Pharmaceuticals and Pharmaceuticals and Pharmaceuticals Sanofi Aventis (SA) Stericort 100 Hydrocortisone Sodium Succinate 13/3.1/0077 Nufenac Diclofenac Sodium 13/3.1/0078 Kamadol Tramadol 13/2.9/0079 Orelox 200 Cefpodoxime Proxetil 13/20.1.1/0080 81 Norgine Pegico Combination 13/11/0081 82 Pharmacia South Africa Avigra 25 Sildenafil Citrate 13/7.1.5/0082 83 Pharmacia South Africa Avigra 50 Sildenafil Citrate 13/7.1.5/0083 84 Pharmacia South Africa Avigra 100 Sildenafil Citrate 13/7.1.5/0084
6 Government Gazette 14 August 2013 5263 85 86 87 88 89 90 91 Pharmacare 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 Bliss GVS Pharma Bliss GVS Pharma Dynafil 25 mg Sildenafil Citrate 13/7.1.5/0085 Dynafil 50 mg Sildenafil Citrate 13/7.1.5/0086 Dynafil 100 mg Sildenafil Citrate 13/7.1.5/0087 Eryko-250 Erythromycin Stearate 13/20.1.1/0088 Woodwards Cough Mixture Honey Woodwards Cough Mixture Blackcurrant Woodwards Cough Mixture Orange Lennon Cough Mixture Blackcurrant Lennon Cough Mixture Honey Lennon Cough Mixture Orange Mucospect Expectorant Honey Mucospect Expectorant Orange Guaiphenesin 13/10.1/0089 Guaiphenesin 13/10.1/0090 Guaiphenesin 13/10.1/0091 Guaiphenesin 13/10.1/0092 Guaiphenesin 13/10.1/0093 Guaiphenesin 13/10.1/0094 Guaiphenesin 13/10.1/0095 Guaiphenesin 13/10.1/0096 Trandopress 2 mg Trandolapril 13/7.1.3/0097 Trandopress 0,5 mg Trandolapril 13/7.1.3/0098 Aspen Teicoplanin 200 Teicoplanin 13/20.1.1/0099 Aspen Teicoplanin 240 Teicoplanin 13/20.1.1/0100 Ziapro 5 mg Bisoprolol Fumarate 13/5.2/0101 Ziapro 10 mg Bisoprolol Fumarate 13/5.2/0102 Aspen Carvedilol 6.25 Carvedilol 13/7.1.3/0103 Durobac Double Strength Sulphamethoxazole, Trimethoprim 13/20.2.1/0104 Conlax-10 Bisacodyl 13/11.5/0105 Imazole Clotrimazole 13/18.6/0106 Vavirex 500 Valaciclovir 13/2.2.8/0107 Tramaspen 50 mg Tramadol 13/2.9/0108 Vaticol XL Fluvastatin Sodium 13/7.5/0109 Bactricef 1 g Cefepime 13/20.1.1/0110
5263 Government Gazette 14 August 2013 7 111 112 113 114 115 Nova Pharmaceuticals Dynator 10 mg Atorvastatin Sodium 13/7.5/0111 Dynator 20 mg Atorvastatin Sodium 13/7.5/0112 Dynator 40 mg Atorvastatin Sodium 13/7.5/0113 Dynator 80 mg Atorvastatin Sodium 13/7.5/0114 Andolex-C Lozenges Orange Benzydamine, Cetylpyridium Cloride 13/16.4/0115 116 Teva Vinorelbine 50 Vinorelbine Tartararte 13/26/0116 117 Sandoz SA Sintrine 5 Montelukast Sodium 13/10.2.2/0117 118 Sandoz SA Sintrine 4 Montelukast Sodium 13/10.2.2/0118 119 Sandoz SA Sintrine 10 Montelukast Sodium 13/10.2.2/0119 120 121 122 123 124 Pfizer Laboratories Depo-Medprol 40 mg Injection Methyprednisolone Acetate 13/3.1/0120 Fluracedyl 250 mg 5-Fluorouracil 13/26/0121 Fluracedyl 500 mg 5-Fluorouracil 13/26/122 Fluracedyl 1 000 mg 5-Fluorouracil 13/26/123 Fluracedyl 5 000 mg 5-Fluorouracil 13/26/0124 125 Sandoz SA Clarihexal 500 XL Clarithromycin 13/20.1.1/0125 126 Azathioprine 50 PCH Azathioprine 13/26/0126 127 128 129 130 131 132 133 134 135 Biotech Laboratories ABIC Leucovorin 100 mg/10 ml Injection Abic Leucovorin 300 mg/30 ml Injection Abic Leucovorin 200 mg/20 ml Injection Akurit-Z Kid Akurit-4 Akurit-3 Leucovorin Calcium 13/8.3/0127 Leucovorin Calcium 13/8.3/0128 Leucovorin Calcium 13/8.3/0129 Rifampicin, Isoniazid, Pyrazinamide Rifampicin, Isoniazid, Pyrazinamide, Ethambutol Rifampicin, Isoniazid, Ethambutol 13/20.2.3/0130 13/20.2.3/0131 13/20.2.3/0132 Akurit Tablets Rifampicin, Isoniazid 13/20.2.3/0133 Akurit Kid Rifampicin, Isoniazid 13/20.2.3/0134 Bio-Glibenclamide 5 Glibenclamide 13/21.2/0135
8 Government Gazette 14 August 2013 5263 136 Biotech Laboratories 137 Sandoz SA Quinazide 10/12.5 Tablet 138 Sandoz SA Quinazide 20/12.5 Tablet 139 Sandoz SA Dantron 4 140 Sandoz SA Dantron 8 141 142 143 Reckitt Benckiser Pharmaceuticals (Pty) Sanofi Aventis South Africa Sanofi Aventis South Africa Bio-Metoclopramide 10 mg Metoclopramimide HCI 13/5.7.2/0136 Nurofen for Children Strawberry 144 Hetero Labs Zidolam-N 145 Hetero Labs 146 147 Activo Health (Pty) Activo Health (Pty) Taxotere RTU 20mg/ml Injection Taxotere RTU 80mg/ml Injection Lopinavir and Ritonavir 200/50 mg Acti-prex Terbi-clear 148 Ibumol Forte 149 150 151 152 153 Novartis South Africa Novartis South Africa Novartis South Africa Sanofi Aventis South Africa Sanofi Aventis South Africa Coartem 20mg/120mg Dispersible tablets Quinapril, Hydrochlorothiazide Quinapril, Hydrochlorothiazide Ondansetron Dihydrate Ondansetron Dihydrate 13/7.1.3/0137 13/7.1.3/0138 13/5.10/0139 13/5.10/0140 Ibuprofen 13/2.7/0141 Docetaxel Trihydrate 13/26/0142 Docetaxel Trihydrate 13/26/0143 Lamivudine Zidovudine, Nevirapine 13/20.2.8/0144 Lopinavir, Ritonavir 13/20.2.8/0145 Perindopril Tertbutylamine Terbinafine Ibuprofen, Paracetamol, Codeine Phosphate 13/7.1.3/0146 13/20.2.2/0147 13/2.8/0148 Artemether, Lumefantrine 13/20.2.6/0149 Onbrez Breezhaler 150µg Indacaterol Maleate 13/10.2.1/0150 Onbrez Breezhaier 300µg Indacaterol Maleate 13/20.2.1/0151 Insuman Combo 30/70 Soluble Insulin; Isophane Insulin 13/21.1/0152 Insuman Rapid Insulin 13/21.1/0153 154 Bayer Qlaira Oestradiol valerate, Dienogest 13/21.8.2/0154 155 Bayer Jadelle Levonorgestrel 13/21.8.1/0155 156 157 158 Johnson & Johnson Macleods Pharmaceuticals Macleods Pharmaceuticals Teeth and Gum Defence Listerine Lamihope-ZN Lamihope-T 159 Merck SA Pergoveris 1501.U/ 75 I.U Sodium Fluoride, Thymol, Alcohol (95%) Lamivudine, Zidovudine, Nevirapine Lamivudine USP, Tenofovir disoproxil fumarate Follitropin alfa and Lutropin alfa 13/16.4/0156 13/20.2.8/0157 13/20.2.8/0158 13/21.10/0159 160 Merck SA Cetrotide 0.25 mg Cetrorelix actate 13/21.12/0160 161 Hetero Labs Abacavir Sulfate oral solution USP 20mg/ml Abacavir Sulfate oral solution USP 20mg/ml 13/20.2.8/0161
5263 Government Gazette 14 August 2013 9 162 Hetero Labs Zidovudine Tablets 300 mg 163 Hetero Labs 164 165 166 Zidovudine Oral Solution USP 50 mg / 5ml Zidovudine Tablets 300 mg Zidovudine Oral Solution USP 50 mg / 5ml 13/20.2.8/0162 13/20.2.8/0163 Teva Anastrozole 1mg Anastrozole 1mg 13/21.12/0164 Granisetron Teva 3 Granisetron 3 mg/3ml 13/5.7.2/0165 Granisetron Teva 1 Granisetron 1mg/1ml 13/5.7.2/0166