GOVERNMENT GAZETTE OF THE REPUBLIC OF NAMIBIA. N$4.00 WINDHOEK - 26 July 2011 No. 4761
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1 GOVERNMENT GAZETTE OF THE REPUBLIC OF N$4.00 WINDHOEK - 26 July 2011 No CONTENTS Page GOVERNMENT NOTICE No. 122 Registration of certain medicines: Medicines and Related Substances Control Act, Government Notice MINISTRY OF HEALTH AND SOCIAL SERVICES No 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 Schedule 1 and 2 have been registered in terms of that Act, subject to the following conditions - (a) (b) (c) the manufacturer 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 authorized 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) 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;
2 2 Government Gazette 26 July 2011 No (f) (g) (h) 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 (1); and the Council may review the registration dossier at such intervals as the Council may determine. J. Gaeseb Registrar of Medicines Windhoek, 11 July 2011
3 No Government Gazette 26 July VETERINARY MEDICINES LOT 2 SCHEDULE APPLICANT REGISTERED 1 Merial South Africa 2 Merial South Africa 3 Merial South Africa 4 Merial South Africa 5 Merial South Africa 6 Merial South Africa 7 Merial South Africa 8 Novartis South Africa 9 Merial South Africa 10 Merial South Africa 11 Merial South Africa 12 Merial South Africa 13 Merial South Africa 14 Merial South Africa Intraval Sodium Injection 1 g Intraval Sodium Injection 5 g DOSSAGE OTHER Thiopentone Sodium Injection Each 20 ml vial contains Thiopentone Sodium for injection 1,0 g Thiopentone Sodium Injection Each 100 ml vial contains Thiopentone Sodium for injection 5 g REG. 11/2.1/0146 6/16/2011 NS3 11/2.1/0147 6/16/2011 NS3 Ketofen 5 Ketoprofen Tablet Each tablet contains Ketoprofen 5,0 11/3.1/0148 6/16/2011 NS2 Ketofen 10 Ketofen 20 Ketoprofen Tablet Each tablet contains Ketoprofen 10,0 11/3.1/0149 6/16/2011 NS2 Ketoprofen Tablet Each tablet contains Ketoprofen 20,0 11/3.1/0150 6/16/2011 NS2 Ketofen 10 % Ketoprofen Injection Each 100 ml solution contains Ketoprofen 10,0 g Ketofen 1 % Ketoprofen Injection Each 1 ml solution contains Ketoprofen 10,0 Denagard 10 % Feed Premix Enacard 2.5 Tiamulin Hydrogen Fumarate Premix Each 1 kg Denagard Feed Premix contains Tiamulin Hydrogen Fumarate 100,0 g Enalapril Maleate Tablet Each tablet contains Enalapril Maleate 2,5 Enacard 5 Enalapril Maleate Tablet Each tablet contains Enalapril Maleate 5 Enacard 10 Previcox 57 Previcox 227 Enalapril Maleate Tablet Each tablet contains Enalapril Maleate 10 11/3.1/0151 6/16/2011 NS2 11/3.1/0152 6/16/2011 NS2 11/21.9/0153 6/16/2011 NS1 11/8/0154 6/16/2011 NS2 11/8/0155 6/16/2011 NS2 11/8/0156 6/16/2011 NS2 Firocoxib Tablet Each tablet contains Firocoxib 57,0 11/3.1.2/0157 6/16/2011 NS2 Firocoxib Tablet Each tablet contains Firocoxib 227,0 11/3/1.2/0158 6/16/2011 NS2 Bomathal Injection Thiopentone Sodium Injection Each 250 ml vial contains Thiopentone Sodium equivalent to Thiopentone 5,0 g 11/2.1/0159 6/16/2011 NS3
4 4 Government Gazette 26 July 2011 No SCHEDULE 1 Hoffman - La Roche 2 Hoffman - La Roche 3 Hoffman - La Roche 4 Ranbaxy (S.A.) 5 Ranbaxy (S.A.) 6 Ranbaxy (S.A.) 7 Ranbaxy (S.A.) 8 Cipla Medpro 9 Cipla Medpro 10 Cipla Medpro 11 Cipla Medpro 12 Cipla Medpro 13 Cipla Medpro Recormon 2000 Epoetin Beta solution for injection (prefilled syringe) Recormon 4000 Epoetin Beta solution for injection (prefilled syringe) Recormon 6000 Epoetin Beta solution for injection (prefilled syringe) Each syringe contains Epoetin Beta /30.4/0100 6/16/2011 NS2 Each syringe contains Epoetin Beta /30.4/0101 6/16/2011 NS2 Each syringe contains Epoetin Beta /30.4/0102 6/16/2011 NS2 Atolip 10 Atorvastatin Calcium tablet Each tablet contains Atorvastatin Calcium equivalent to Atorvastatin 10,0 Atolip 20 Atorvastatin Calcium tablet Each tablet contains Atorvastatin Calcium equivalent to Atorvastatin 20,0 Atolip 40 Atorvastatin Calcium tablet Each tablet contains Atorvastatin Calcium equivalent to Atorvastatin 40,0 Atolip 80 Atorvastatin Calcium tablet Each tablet contains Atorvastatin Calcium equivalent to Atorvastatin 80,0 11/7.5/0103 6/16/2011 NS2 11/7.5/0104 6/16/2011 NS2 11/7.5/0105 6/16/2011 NS2 11/7.5/0106 6/16/2011 NS2 Rheugesic Piroxicam tablet Each tablet contains Piroxicam 20 11/3.1/0107 6/16/2011 NS1 Fertomid-50 Clomiphene Citrate tablet Each tablet contains Clomiphene Citrate 50,0 Cefasyn Cefuroxime Axetil tablet Each tablet contains Cefuroxime Axetil equivalent to Cefuroxime 500,0 Cefasyn Cefuroxime Axetil tablet Each tablet contains Cefuroxime.Axetil equivalent to Cefuroxime 250,0 Ultak Ranitidine Hydrochloride Ultak Ranitidine Hydrochloride tablet Each tablet contains Ranitidine Hydrochloride equivalent to Ranitidine 150,0 tablet Each tablet contains Ranitidine Hydrochloride equivalent to Ranitidine 300,0 11/18.8/0108 6/16/2011 NS2 11/20.1.1/0109 6/16/2011 NS2 11/20.1,1/0110 6/16/2011 NS2 1/11.4.3/0111 6/16/2011 NS2 11/11.4.3/0112 6/16/2011 NS2
5 No Government Gazette 26 July Medpro Pharmaceutica (Pty) 15 Cipla Medpro 16 Cipla Medpro 17 Cipla Medpro 18 Cipla Medpro 19 Cipla Medpro 20 Cipla Medpro 21 Cipla Medpro 22 Cipla Medpro 23 Cipla Medpro 24 Cipla Medpro 25 Cipla Medpro Pynmed Caffeine anhydrous; Meprobamate; Codeine Phosphate Paracetamol tablet Each tablet contains Caffeine Anydrous 32, Meprobamate 150, Codeine Phosphate 8 and Paracetamol /2.8/0113 6/16/2011 NS1 Ciplatec 5.0 Enalapril Maleate tablet Each tablet contains Enalapril Maleate 5,0 11/7.1.3/0114 6/16/2011 NS2 Abflex - 4 Caffeine; Codeine Phosphate; Doxylamine Succinate, Paracetamol tablet Each tablet contains Caffeine 30,0, Codeine Phosphate 10,0, Doxylamine Succinate 5,0 and Paracetamol 450,0 11/2.8/0115 6/16/2011 NS1 Carloc 6,25 Carvedilol tablet Each tablet contains Carvedilol 6,25 11/7.1.3/0116 6/16/2011 NS2 Roxxibid 150 Roxithromycin tablet Each tablet contains Roxithromycin 150,0 11/20.1.1/0117 6/16/2011 NS2 Acitab DT Acyclovir tablet Each tablet contains Acyclovir 200,0 11/20.2.8/0118 6/16/2011 NS2 Tensodol Caffeine; Codeine Phosphate; Doxylamine Succinate, Paracetamol tablet Each tablet contains Caffeine 30,0. Codeine Phosphate 10,0, Doxylamine Succinate 5,0 and Paracetamol 450,0 11/2.1/0119 6/16/2011 NS1 Cipla Indapamide Indapamide tablet Each tablet contains Indapamide 2,5 11/71/0120 6/16/2011 NS2 Co-Codamol Codeine Phosphate; Paracetamol Ibugesic Oral Suspension Repivate Betamethasone Valerate effervescent tablet Each effervescent tablet contains Codeine Phosphate 8,0 and Paracetamol 500,0 Ibuprofen oral suspension Each 5,0 ml suspension contains Ibuprofen 100,0 cream Each 15,0 g cream contains Betamethasone Valerate equivalent to Betamethasone 15,0 11/2.8/0121 6/16/2011 NS1 11/3.1/0122 6/16/2011 NS1 11/13.4.1/0123 6/16/2011 NS2 Acitab DT Acyclovir tablet Each tablet contains Acyclovir 400,0 11/20.2.8/0124 6/16/2011 NS2
6 6 Government Gazette 26 July 2011 No Cipla-Medpro (Pry) 27 Cipla-Medpro 28 Cipla-Medpro 29 Ranbaxy (SA) 30 Ranbaxy (SA) 31 Ranbaxy (SA) Pty 32 Ranbaxy (SA) Pty 33 Ranbaxy (SA) Pty 34 The Biovac Institute 35 The Biovac Institute 36 Merck SA (Pty) 37 Merck SA (Pty) 38 Merck SA (Pty) 39 Pharmacare Optilol 0,25% Ophthalmic Solution Optilol 0,5% Ophthalmic Solutio Timolol Maleate ophthalmic solution Timolol Maleate ophthalmic solution Prazoloc 40 IV Pantoprazole Sodium Sesquihydrate Conoran IV Pantoprazole Sodium Sesquihydrate Each vial solution contains Timolol Maleate equivalent to Timolol 0,25 % w/v (2,5 /ml) Each vial solution contains Timolol Maleate equivalent to Timolol 0.5%w/v (5/ml) Injection Each vial contains 42,3 Pantoprazole Sodium Sesquihydrate equivalent topantoprazole 40,0 Injection Each ml contains Pantoprazole Sodium Sesquihydrate equivalent to Pantoprazole 40 Tazogen Piperacillin Sodium Injection Each vial contains Piperacillin Sodium equivalent to Piperacillin 4g Tazobactam Sodium equivalent to Tazobactam 500 Dilair 4 Montelukast Sodium tablet Each tablet contains Montelukast Sodium equivalent to Montelukast 4 Dilair 5 Montelukast Sodium tablet Each tablet contains Montelukast Sodium equivalent to Montelukast 5 Dilair 10 Montelukast Sodium tablet Each tablet contains Montelukast Sodium equivalent to Montelukast 10 TetaBio Tetanus Toxoid Injection Each 0.5 ml dose contains purified Tetanus Toxoid 40 lu MeasBio Measles Attenuated Virus Injection Each 0.5 ml dose contains not less than 1000 CCIDS0 CAM 70 strain of Measles live, attenuated virus Euthyrox 25 µg Levothyroxine tablet Each tablet contains Levothyroxine Sodium 25 µg Euthyrox 50 µg Levothyroxine tablet Each tablet contains Levothyroxine Sodium 50 µg Euthyrox 100 µg Levothyroxine tablet Each tablet contains Levothyroxine Sodium 100 µg Aspen Cetirizine 1 /ml Cetirizine Dihydrochloride oral solution Each 1 ml solution contains Cetirizine Dihydrochloride 1,0 11/15.4/0125 6/16/2011 NS2 11/15.4/0126 6/16/2011 NS2 11/11.4.3/0127 6/16/2011 NS2 11/11.4.3/0128 6/16/2011 NS2 11/201.2/0129 6/16/2011 NS2 11/10.2.2/0130 6/16/2011 NS2 11/10.2.2/0131 6/16/2011 NS2 11/10.2.2/0132 6/16/2011 NS2 11/30.1/0133 6/16/2011 NS1 11/30.1/0134 6/16/2011 NS1 11/21.3/0135 6/16/2011 NS2 11/21.3/0136 6/16/2011 NS2 11/21.3/0137 6/16/2011 NS2 11/5.7.1/0138 6/16/2011 NS1
7 No Government Gazette 26 July Sanofi-Aventis South Africa 41 Pharmacare 42 Pharmacare 43 Pharmacare 44 Cipla-Medpro 45 Cipla-Medpro Rifinah 150/75 Rifampicin, Isoniazid tablet Each tablet contains Rifampicin 150,0 and Isoniazid 75,0 11/20.2.3/0139 6/16/2011 NS2 Avirez Efavirenz tablet Each tablet contains Efavirenz 600,0 11/20.2.8/0140 6/16/2011 NS2 Aspen Levofloxacin 250 Aspen Levofloxaccin 500 Duolin HFA Inhalaer Budeflam Respules 0.25 Levofloxacin Hemihydrate Levofloxacin Hemihydrate IpratropiumBromide, Salbutamol Sulphate tablet Each tablet contains Levofloxacin Hemihydrate equivalent to Levofloxacin 250,0 tablet Each tablet contains Levofloxacin Hemihydrate equivalent to Levofloxacin 500,0 Inhaler Each Actuation delivers Ipratropium Bromide 21 pg equiv. to Ipratropium 20.0 pg. Salbutamol Sulphate equiv. to Salbutamol 100 rig Budesonide Respules Each 1ml suspension contains Budesonide 0,25 11/20.1.1/0141 6/16/2011 NS2 11/20.1.1/0142 6/16/2011 NS2 11/20.2.1/0143 6/16/2011 NS2 11/21.5.1/0144 6/16/2011 NS2 46 Cipla-Medpro Budeflam Respules 0.5 Budesonide Respules Each 1 ml suspension contains Budesonide 0,5 11/21.5.1/0145 6/16/2011 NS2
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A B Page 6 7 8 9 0 C 6 7 Page 8 9 0 D E Page 6 7 8 9 F Page 6 7 8 9 G H Page 6 7 8 9 I 6 7 Page 6 8 9 0 J 6 7 Page 7 K 6 7 8 9 L Page 8 6 7 8 9 0 Page 9 6 7 8 9 0 Page 0 OFFERâ S INJECTABLES Alimentary
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OLENS HEALTH CARE PVT. LTD SHOP NO: 20, 2 nd FLOOR, OLD ROPAR ROAD NEAR SAMADHI GATE, MOTOR MARKET MANIMAJRA, CHANDIGARH-160101, CONTACT NO: +919466093266, +918558992442 E-MAIL: olens.healthcare@gmail.com