MEDICINES CONTROL COUNCIL NOTIFICATION OF REGISTRATION OF MEDICINES BY THE REGISTRAR IN TERMS OF SECTION 17 OF THE MEDICINES AND RELATED SUBSTANCES CONTROL ACT 101 OF 1965 31/5.2/0332 BE-TABS 32/5.2/0670 BE-TABS 35/8.1/0066 WYETH SOUTH AFRICA 35/8.1/0067 WYETH SOUTH AFRICA 35/8.1/0068 WYETH SOUTH AFRICA 35/34/0069 WYETH SOUTH AFRICA 35/20.2.8/0075 BRISTOL-MYERS SQUIBB 36/7.1.3/0238 BRISTOL-MYERS SQUIBB 36/20.2.2/0245 LEBASI CC B-BLOCK 50 B-BLOCK 100 REFACTO 250 IU REFACTO 500 IU REFACTO 1 000 IU SODIUM CHLORIDE DILUENT FOR REFACTO INJECTION VIDEX 200 mg TABLET MAXARETIC VARI-CLOTRIMAZOLE 1 % m/m TOPICAL CREAM ATENOLOL 50,0 mg ATENOLOL 100,0 mg ALPHA EACH VIAL MOROCTOCOG 250,0 ii.u. EACH VIAL MOROCTOCOG ALPHA 500,0 i.u. EACH VIAL MOROCTOCOG ALPHA 1000,0 i.u. EACH 1,0 ml SOLUTION SODIUM CHLORIDE 9,0 mg DIDANOSINE 200,0 mg FOSINOPRIL SODIUM 20,0 mg 12,5 mg EACH 1,0 g CREAM CLOTRIMAZOLE 12.19 Notification of Registration Feb 05v2 Jun2005 Page 1 of 5
36/21.10/0307 SERONO SOUTH AFRICA 36/21.8.1/0339 SERVIER LABORATORIES SOUTH AFRICA 36/21.8.1/0340 SERVIER LABORATORIES SOUTH AFRICA GONAL F 1 200 IU MULTI-DOSE SERVIER ESTRADIOL AERODIOL EACH VIAL : FOLLITROPIN ALFA 1 200,0 I.U. EACH 0,07 ml SOLUTION 150,0 ug EACH 0,07 ml SOLUTION 150,0 ug 36/22.1.4/0361 PHARMA NATURA (PTY) VITA FORCE A 50 000 IU EACH CAPSULE VITAMIN A PALMITATE 50 000 IU RETINOL 1 36/2.8/0380 PHARMACARE LIMITED IBUMOL FORTE IBUPROFEN 200,0 mg PARACETAMOL 350,0 mg CODEINE PHOSPHATE 36/11.3/0400 ADCOCK INGRAM LIMITED 36/11.3/0401 ADCOCK INGRAM LIMITED 36/21.5.1/0417 SCHERING-PLOUGH 36/21.5.1/0418 SCHERING-PLOUGH 36/21.5.1/0419 SCHERING-PLOUGH DIETENE SYRUP NOBESE SYRUP NASONEX UNSCENTED RINELON UNSCENTED UNICLAR UNSCENTED EACH 5,0 ml SYRUP : NORPSEUDOEPHEDRINE HYDROCHLORIDE 20,0 mg EACH 5,0 ml SYRUP NORPSEUDOEPHEDRINE HYDROCHLORIDE 20,0 mg TO 50,0 ug TO 50,0 ug TO 50,0 ug 36/26/0422 SCHERING FLUDARA ORAL FLUDARABINE PHOSPHATE 36/6.1/0457 MERCK CARDICOR 2,5 2,5 mg 12.19 Notification of Registration Feb 05v2 Jun2005 Page 2 of 5
36/6.1/0458 MERCK CARDICOR 5 36/6.1/0459 MERCK CARDICOR 10 36/34/0485 B. BRAUN MEDICAL 36/34/0486 B. BRAUN MEDICAL 36/7.1.3/0501 XIXIA 36/7.1.3/0502 XIXIA 36/7.1.3/0503 XIXIA 37/2.5/0051 LEBASI CC 37/2.5/0052 LEBASI CC 37/2.5/0053 LEBASI CC 37/7.5/0210 PFIZER LABORATORIES COMBIBIC SH-EL 02 BICAFLAC SH-BIC 35 ZEPROSIL 5 mg ZEPROSIL 10 mg ZEPROSIL 20 mg LAMITOR-25 LAMITOR-50 LAMITOR-100 LIPITOR 80 EACH 1000,0 ml SOLUTION : SODIUM CHLORIDE 4,21 g POTASSIUM CHLORIDE 1,34 g CALCIUM CHLORIDE DIHYDRATE 1,98 g MAGNESIUM CHLORIDE HEXAHYDRATE 0,91g GLUCOSE 9,0 g EACH 1000,0 ml SOLUTION : SODIUM CHLORIDE 6,18 g SODIUM HYDROGEN CARBONATE 3,59 g : LISINOPRIL : LISINOPRIL : LAMOTRIGINE 2 LAMOTRIGINE 50,0 mg LAMOTRIGINE 100,0 mg : ATORVASTATIN CALCIUM TRIHYDRATE ATORVASTATIN 80,0 mg 37/21.8.1/0214 SCHERING CLIMARA 25 EACH PATCH : ESTRADIOL 1,97 mg 37/11.4.3/0325 CIPLA LIFE SCIENCES 37/20.1.1/0402 HEXAL PHARMA SA 37/20.1.1/0403 HEXAL PHARMA SA CIPLA-RANITIDINE-75 ZINAHEXAL 125 ZINAHEXAL 250 : RANITIDINE HYDROCHLORIDE RANITIDINE 7 CEFUROXIME 12 12.19 Notification of Registration Feb 05v2 Jun2005 Page 3 of 5
37/20.1.1/0404 HEXAL PHARMA SA 37/5.8/0448 GROUP LABORATORIES SA 37/21.8.2/0456 NOVARTIS SOUTH AFRICA 37/21.8.2/0457 NOVARTIS SOUTH AFRICA 37/7.1.3/0475 PHARMA DYNAMICS 37/7.1.3/0476 PHARMA DYNAMICS 37/7.1.3/0477 PHARMA DYNAMICS 37/7.1.3/0478 PHARMA DYNAMICS 37/5.2/0516 HEXAL PHARMA SA ZINAHEXAL 500 SUDAFED 12 HOUR RELIEF ESTALIS 50/140 ESTALIS 50/250 LISORETIC 10/12,5 LISORETIC 20/12,5 PHARMA DYNAMICS LISINOPRIL/HCT 10/12,5 PHARMA DYNAMICS LISINOPRIL/HCT 20/12,5 BISOHEXAL 5 CEFUROXIME 250,0 mg CEFUROXIME 500,0 mg EACH CAPSULE PSEUDOEPHEDRINE HYDROCHLORIDE 120,0 mg EACH PATCH O OESTRADIOL 0,62 mg NORETHISTERONE ACETATE 2,70 mg EACH PATCH O OESTRADIOL 0,512 mg NORETHISTERONE ACETATE 4,80 mg LISINOPRIL : : LISINOPRIL 10,0,mg : 37/5.2/0517 HEXAL PHARMA SA BISOHEXAL 10 37/5.7.1/0651 UNICHEM SA ZYNCET CETIRIZINE HYDROCHLORIDE 37/30.4/0683 PHARMAPLAN DYSPORT EACH VIAL 12.19 Notification of Registration Feb 05v2 Jun2005 Page 4 of 5
CLOSTRIDIUM BOTULINUM TYPE A TOXIN- HAEMAGGLUTININ COMPLEX 500 U 38/5.2/0080 MERCK BETACOR 5 : 38/5.2/0081 MERCK BETACOR 10 : 38/26/0179 ROCHE PRODUCTS 38/26/0180 ROCHE PRODUCTS 38/20.2.8/0181 ROCHE PRODUCTS 38/7.1/0209 GENERIX 38/7.1/0218 GENERIX A38/7.1/0355 A38/7.1/0356 A38/7.5/0370 A38/7.5/0372 A39/7.1/0117 A39/7.1/0120 GENERIX GENERIX CIPLA LIFE SCIENCES PEGASYS 135 PEGASYS 180 COPEGUS 200 DAZOSYN 1 mg DAZOSYN 4 mg AMLOSYN 5 mg AMLOSYN 10 mg CIPLA-SIMVASTATIN 40 SIMCARD 40 LOVASC 5 LOVASC 10 EACH PRE-FILLED SYRINGE PEGINTERFERON ALFA-2a 135,0 ug EACH PRE-FILLED SYRINGE PEGINTERFERON ALFA-2a 180,0 ug RIBAVIRIN 200,0 mg DOXAZOSIN MESYLATE DOXAZOSIN 1,0 mg DOXAZOSIN MESYLATE DOXAZOSIN 4,0 mg : AMLODIPINE MESYLATE AMLODIPINE AMLODIPINE MESYLATE AMLODIPINE SIMVASTATIN 40,0 mg SIMVASTATIN 40,0 mg AMLODIPINE BESYLATE AMLODIPINE AMLODIPINE BESYLATE AMLODIPINE REGISTRAR OF MEDICINES DR ZOKUFA 12.19 Notification of Registration Feb 05v2 Jun2005 Page 5 of 5