MEDICINES CONTROL COUNCIL NOTIFICATION OF REGISTRATION OF MEDICINES BY THE REGISTRAR IN TERMS OF SECTION 17 OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT 101 OF 1965) 34/30.2/0501 JE ECKARD OCTAGAM EACH 1,0 ml SOLUTION HUMAN NORMAL IMMUNOGLOBULIN G 50,0 37/28/0521 AXIM PARMACEUTICALS (PTY) A39/5.4/0212 A39/5.4/0224 A39/5.4/0226 A39/16.2/0544 A40/5.10/0213 A40/21.5.1/0224 JANSSEN (PTY) JANSSEN (PTY) JANSSEN (PTY) ALCON LABORATORIES (S.A.) (PTY) ADCOCK INGRAM LIMITED SPECPHARM (PTY) AXIM READICAT 2 % LYRINEL 5 LYRINEL 10 LYRINEL 15 CILODEX EAR DROPS ADCO-NETRIN 2 /ml SPEC-BUDESONIDE 100 EACH 100,0 ml SUSPENSION BARIUM SULPHATE 2,0940 g OXYBUTYNIN 5,0 OXYBUTYNIN 10,0 OXYBUTYNIN 15,0 EACH 1,0 ml SUSPENSION CIPROFLOXACIN : CIPROFLOXACIN 3,0 DEXAMETHASONE 1,0 EACH 2,0 ml SOLUTION ONDANSETRON 4,0 EACH METERED DOSE DELIVERS: BUDESONIDE 100,0 μg 12.42 Notification JunAug08 v1.doc Nov 2008 Page 1 of 8
41/24/0136 B BRAUN MEDICAL (PTY) 41/7.5/0298 ASTRAZENECA (PTY) 36/2.2/0235 EQUITY (PTY) 37/20.2.2/0100 JANSSEN (PTY) 37/7.1/0302 COMPUPHARM (PTY) 37/7.1/0303 COMPUPHARM (PTY) 37/8.3/0434 PHARMAPLAN (PTY) 37/20.2.2/0630 JANSSEN (PTY) 0,9 % SODIUM CHLORIDE INFUSION B. BRAUN CRESTOR 5 DOXYNITE DROPS TIBOZOLE FEDALOC 30 SR FEDALOC 60 SR COSMOFER MICMAT 38/20.2.2/0157 PHARMACARE LIMITED CANDIZOLE VAGINAL TABLET A05/3.1.1/03 A05/3.1.1/04 A38/4/0412 CIPLA MEDPRO (PTY) PFIZER THE DENTAL WAREHOUSE (PTY) PETCAM RIMADYL AQUEOUS INJECTION SEPTANEST WITH ADRENALINE 1/100 000 A38/7.1.3/0604 PHARMACARE LIMITED ASPEN ENALAPRIL 10 A38/7.1.3/0605 PHARMACARE LIMITED ASPEN ENALAPRIL 20 A39/20.2.2/0009 A39/20.2.2/0010 HEXAL PHARMA (PTY) HEXAL PHARMA (PTY) TERBANE 10 TERBINISIL 10 EACH 1 000, 0 ml SOLUTION SODIUM CHLORIDE 9,0 g ROSUVASTATIN CALCIUM : ROSUVASTATIN 5,0 EACH 0,5 ml DROPS CONTAIN: DOXYLAMINE SUCCINATE 25,0 MICONAZOLE NITRATE 10,0 NIFEDIPINE 30,0 NIFEDIPINE 60,0 EACH 1,0 ml SOLUTION IRON DEXTRAN EQUIVALENT TO ELEMENTARY IRON 50,0 MICONAZOLE NITRATE 10,0 CLOTRIMAZOLE 500,0 EACH 1,0 ml SUSPENSION MELOXICAM 1,5 EACH 1,0 ml SOLUTION CARPROFEN 50,0 EACH 2,2 ml CARTRIDGE ARTICAINE 88,0 ADRENALINE TARTRATE ADRENALINE 22,0 µg ENALAPRIL MALEATE 10,0 ENALAPRIL MALEATE 20,0 EACH 1,0 g CREAM TERBINAFINE 10,0 EACH 1,0 g CREAM TERBINAFINE 10,0 12.42 Notification JunAug08 v1.doc Nov 2008 Page 2 of 8
A40/2.5/0004 PHARMACARE LIMITED ASPEN PHENYTOIN SODIUM 250 /5 ml A40/20.1.1/0114 A40/3.1/0174 A40/2.9/0203 A40/7.1.3/0292 A40/7.1.3/0293 A40/34/0502 A40/21.12/0656 A40/7.5/0711 A40/20.1.1/0734 PHARMAPLAN (PTY) TEMA MEDICAL (PTY) JANSSEN (PTY) SANOFI-SYNTHELABO (PTY) SANOFI-SYNTHELABO (PTY) PHARMAPLAN (PTY) DR REDDY S GULF DRUG COMPANY (PTY) SANDOZ S.A. (PTY) CIPROCINA PEDEA DUROGESIC 12 µg/h CO-SARBEN 150/12,5 CO-SARBEN 300/12,5 AVONEX SOLUTION FOR INJECTION DRL-FINASTERIDE 1 GULF PRAVASTATIN 20 OREOXAL 40 /5 ml EACH 5,0 ml SOLUTION PHENYTOIN SODIUM 250,0 EACH 1,0 ml SOLUTION CIPROFLOXACIN LACTATE CIPROFLOXACIN 2,0 EACH AMPOULE IBUPROFEN 10,0 EACH PATCH FENTANYL 2,1 IRBESARTAN 150,0 IRBESARTAN 300,0 EACH PRE-FILLED SYRINGE INTERFERON BETA 1a 30,0 µg FINASTERIDE 1,0 PRAVASTATIN SODIUM 20,0 EACH 5,0 ml SUSPENSION CEFPODOXIME PROXETIL CEFPODOXIME 40,0 A40/20.2.8/0736 MSD (PTY) STOCRIN 50 EFAVIRENZ 50,0 A40/20.2.8/0737 MSD (PTY) STOCRIN 200 EFAVIRENZ 200,0 41/7.1.3/0042 ZYDUS HEALTHCARE S.A. (PTY) 41/5.10/0075 SANDOZ S.A. (PTY) DIACE CO 20 TABLETS DANTRON 4 VIAL LISINOPRIL DIHYDRATE LISINOPRIL 20,0 EACH 2,0 ml SOLUTION ONDANSETRON DIHYDRATE ONDANSETRON 4,0 12.42 Notification JunAug08 v1.doc Nov 2008 Page 3 of 8
41/5.10/0076 SANDOZ S.A. (PTY) 41/5.10/0077 SANDOZ S.A. (PTY) 41/5.10/0078 SANDOZ S.A. (PTY) 41/7.1.3/0187 BE-TABS (PTY) 41/7.1.3/0188 BE-TABS (PTY) 41/2.5/0271 ARROW PHARMA 41/2.5/0272 ARROW PHARMA 41/2.5/0273 ARROW PHARMA 41/2.5/0274 ARROW PHARMA 41/2.5/0275 ARROW PHARMA 41/20.2.8/0296 LEBASI cc 41/18/0299 ADCOCK INGRAM CRITICAL CARE (PTY) DANTRON 8 VIAL NAUSETRON 4 VIAL NAUSETRON 8 VIAL LYSIN CO 10 LYSIN CO 20 LAMOD 5 LAMOD 25 LAMOD 50 LAMOD 100 LAMOD 200 VARI-ZIDOVUDINE 300 FOSRENOL 250 EACH 4,0 ml SOLUTION ONDANSETRON DIHYDRATE : ONDANSETRON 8,0 EACH 2,0 ml SOLUTION ONDANSETRON DIHYDRATE : ONDANSETRON 4,0 EACH 4,0 ml SOLUTION ONDANSETRON DIHYDRATE : ONDANSETRON 8,0 LISINOPRIL DIHYDRATE LISINOPRIL 10,0 LISINOPRIL DIHYDRATE LISINOPRIL 20,0 LAMOTRIGINE 5,0 LAMOTRIGINE 25,0 LAMOTRIGINE 50,0 LAMOTRIGINE 100,0 LAMOTRIGINE 200,0 ZIDOVUDINE 300,0 LANTHANUM CARBONATE HYDRATE LANTHANUM 250,0 12.42 Notification JunAug08 v1.doc Nov 2008 Page 4 of 8
41/18/0300 ADCOCK INGRAM CRITICAL CARE (PTY) 41/18/0301 ADCOCK INGRAM CRITICAL CARE (PTY) 41/18/0302 ADCOCK INGRAM CRITICAL CARE (PTY) 41/1.2/0371 GLAXOSMITHKLINE 41/1.2/0372 GLAXOSMITHKLINE 41/20.1.1/0388 AUROBINDO PHARMA (PTY) 41/20.1.1/0389 AUROBINDO PHARMA (PTY) 41/7.5/0409 ZYDUS HEALTHCARE S.A. (PTY) 41/7.5/0410 ZYDUS HEALTHCARE S.A. (PTY) 41/7.5/0411 ZYDUS HEALTHCARE S.A. (PTY) 41/7.5/0412 ZYDUS HEALTHCARE S.A. (PTY) 41/1.2/0440 ZYDUS HEALTHCARE S.A. (PTY) 41/1.2/0441 ZYDUS HEALTHCARE S.A. (PTY) 41/1.2/0442 ZYDUS HEALTHCARE S.A. (PTY) FOSRENOL 500 FOSRENOL 750 FOSRENOL 1 000 WELLBUTRIN XL 150 WELLBUTRIN XL 300 AURO-CEFALEXIN TABLETS 500 AURO-CEFALEXIN TABLETS 1 000 COLITE 10 TABLETS COLITE 20 TABLETS COLITE 40 TABLETS COLITE 80 TABLETS ODIVEN 37,5 ODIVEN 50 ODIVEN 75 LANTHANUM CARBONATE HYDRATE LANTHANUM 500,0 LANTHANUM CARBONATE HYDRATE LANTHANUM 750,0 LANTHANUM CARBONATE HYDRATE LANTHANUM 1 000,0 BUPROPION 150,0 BUPROPION 300,0 CEFALEXIN MONOHYDRATE CEFALEXIN 500,0 CEFALEXIN MONOHYDRATE CEFALEXIN 1 000,0 PRAVASTATIN SODIUM 10,0 PRAVASTATIN SODIUM 20,0 PRAVASTATIN SODIUM 40,0 PRAVASTATIN SODIUM 80,0 37,5 50,0 75,0 12.42 Notification JunAug08 v1.doc Nov 2008 Page 5 of 8
41/20.1.2/0532 AUROBINDO PHARMA (PTY) 41/20.1.2/0533 AUROBINDO PHARMA (PTY) 41/20.1.2/0534 AUROBINDO PHARMA (PTY) 41/20.1.2/0535 AUROBINDO PHARMA (PTY) 41/20.1.2/0536 AUROBINDO PHARMA (PTY) 41/20.1.2/0537 AUROBINDO PHARMA (PTY) 41/20.1.2/0546 BE-TABS (PTY) BINDOCLAV 375 BINDOCLAV 625 BINDOCLAV 1 000 AURO-AMOXICLAV 375 AURO-AMOXICLAV 625 AURO-AMOXICLAV 1 000 BETACLAV 375 AMOXYCILLIN 250,0 AMOXYCILLIN 500,0 AMOXYCILLIN 875,0 AMOXYCILLIN 250,0 AMOXYCILLIN 500,0 AMOXYCILLIN 875,0 AMOXYCILLIN 250,0 12.42 Notification JunAug08 v1.doc Nov 2008 Page 6 of 8
41/20.1.2/0547 BE-TABS (PTY) 41/20.1.2/0548 BE-TABS (PTY) 41/5.4.1/0604 GLAXOSMITHKLINE 41/5.4.1/0605 GLAXOSMITHKLINE 41/5.4.1/0606 GLAXOSMITHKLINE 41/5.4.1/0607 GLAXOSMITHKLINE 41/20.2.8/0737 ADCOCK INGRAM LIMITED 41/20.2.8/0738 ADCOCK INGRAM LIMITED 41/8.1/0812 GULF DRUG COMPANY (PTY) 41/8.1/0813 GULF DRUG COMPANY (PTY) 41/7.1.3/0820 CIPLA MEDPRO (PTY) 41/7.1.3/0821 CIPLA MEDPRO (PTY) BETACLAV 625 BETACLAV 1 000 REQUIP XL 2 REQUIP XL 3 REQUIP XL 4 REQUIP XL 8 ADO-ZIDOVUDINE 100 CAPSULES ADO-ZIDOVUDINE 250 CAPSULES GULF AMLODIPINE 5 GULF AMLODIPINE 10 CIPLAZAR 25 CIPLAZAR 50 AMOXYCILLIN 500,0 AMOXYCILLIN 875,0 ROPINIROLE ROPINIROLE 2,0 ROPINIROLE ROPINIROLE 3,0 ROPINIROLE ROPINIROLE 4,0 ROPINIROLE ROPINIROLE 8,0 EACH CAPSULE ZIDOVUDINE 100,0 EACH CAPSULE ZIDOVUDINE 250,0 AMLODIPINE BESYLATE AMLODIPINE 5,0 AMLODIPINE BESYLATE AMLODIPINE 10,0 LOSARTAN POTASSIUM LOSARTAN 25,0 LOSARTAN POTASSIUM LOSARTAN 50,0 12.42 Notification JunAug08 v1.doc Nov 2008 Page 7 of 8
41/7.1.3/0822 CIPLA MEDPRO (PTY) 41/1.2/0843 DR REDDY S 41/1.2/0844 DR REDDY S 41/1.2/0845 DR REDDY S 41/7.1/0935 PHARMAPLAN (PTY) 41/7.1/0936 PHARMAPLAN (PTY) 41/1.2/1007 DR REDDY S 41/1.2/1008 DR REDDY S 41/1.2/1009 DR REDDY S 41/21.2/1089 PHARMAPLAN (PTY) 41/21.2/1090 PHARMAPLAN (PTY) 41/21.2/1091 PHARMAPLAN (PTY) MS MANDISA HELA REGISTRAR OF MEDICINES CIPLAZAR 100 CITRAZ 5 CITRAZ 10 CITRAZ 20 ZANERIL 10/10 ZANERIL 10/20 VENELA 37,5 VENELA 50 VENELA 75 METORED 500 METORED 850 METORED 1 000 LOSARTAN POTASSIUM LOSARTAN 100,0 ESCITALOPRAM OXALATE ESCITALOPRAM 5,0 ESCITALOPRAM OXALATE ESCITALOPRAM 10,0 ESCITALOPRAM OXALATE ESCITALOPRAM 20,0 LERCANIDIPINE 10,0 ENALAPRIL MALEATE 10,0 LERCANIDIPINE 10,0 ENALAPRIL MALEATE 20,0 37,5 50,0 75,0 METFORMIN 500,0 METFORMIN 850,0 METFORMIN 1 000,0 12.42 Notification JunAug08 v1.doc Nov 2008 Page 8 of 8