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) 42/2.5/0453 ZYDUS HEALTHCARE SA ZYDUS TOPIRAMATE SPRINKLES 25 42/13.12/0743 GALDERMA LABORATORIES (SA) REDAP CREAM 42/2.5/0862 AKACIA HEALTHCARE KEPLEV 250 42/2.5/0863 AKACIA HEALTHCARE KEPLEV 500 42/2.5/0864 AKACIA HEALTHCARE KEPLEV 750 42/2.5/0865 AKACIA HEALTHCARE KEPLEV 1 000 42/20.2.8/1047 PHARMACARE LIMITED ASPEN RITONAVIR 100 mg 43/2.7/0513 RECKITT BENCKISER NUROACT 200 mg 43/2.7/0514 RECKITT BENCKISER 43/5.7.2/0527 AKACIA HEALTHCARE NUROACT 400 mg GRANTYL 1 mg/1 ml Each SPRINKLE CAPSULE TOPIRAMATE 25,0 mg Each 1,0 g CREAM ADAPALENE 1,0 mg LEVETIRACETAM 250,0 mg LEVETIRACETAM 500,0 mg LEVETIRACETAM 750,0 mg LEVETIRACETAM 1 000,0 mg Each CAPSULE RITONAVIR SODIUM IBUPROFEN equivalent to IBUPROFEN 200,0 mg SODIUM IBUPROFEN equivalent to IBUPROFEN 400,0 mg Each 1,0 ml SOLUTION GRANISETRON HYDROCHLORIDE GRANISETRON 1,0 mg 12.84_Notification_of Mar15_v1 April 2015 Page 1 of 6
43/5.7.2/0528 AKACIA HEALTHCARE 43/20.2.8/0848 AUROBINDO PHARMA GRANTYL 3 mg/3 ml STALANEV Each 3,0 ml SOLUTION GRANISETRON HYDROCHLORIDE GRANISETRON 3,0 mg LAMIVUDINE 150,0 mg STAVUDINE 30,0 mg NEVIRAPINE 200,0 mg 43/17.1/1135 SANDOZ SA ROCUSTETIC 50 Each 5,0 ml SOLUTION 50,0 mg 43/17.1/1136 SANDOZ SA ROCUSTETIC 100 Each 10,0 ml SOLUTION 43/17/1/1140 SANDOZ SA SANDOZ ROCURONIUM 50 43/17/1/1141 SANDOZ SA SANDOZ ROCURONIUM 100 44/20.1.1/0273 ACCORD HEALTHCARE 44/20.1.1/0274 ACCORD HEALTHCARE 44/20.1.1/0275 ACCORD HEALTHCARE 44/20.1.1/0276 ACCORD HEALTHCARE PIRABAX 2/0,25 PIRABAX 4/0,5 ACCORD PIPERACILLIN PLUS TAZOBACTAM 2/0,25 ACCORD PIPERACILLIN PLUS TAZOBACTAM 4/0,5 44/20.2.2/0354 SPECPHARMA SPEC FLUCONAZOLE 100 mg/50 ml Each 5,0 ml SOLUTION 50,0 mg Each 10,0 ml SOLUTION Each VIAL PIPERACILLIN 2,0 g TAZOBACTAM 250,0 mg Each VIAL PIPERACILLIN 2,0 g TAZOBACTAM 500,0 mg Each VIAL PIPERACILLIN 2,0 g TAZOBACTAM 250,0 mg Each VIAL PIPERACILLIN 4,0 g TAZOBACTAM 500,0 mg Each 50,0 ml SOLUTION FLUCONAZOLE 44/34/0438 DR REDDY S COGNIMET 10 MEMANTINE 12.84_Notification_of Mar15_v1 April 2015 Page 2 of 6
LABORATORIES 44/26/0586 DR REDDY S LABORATORIES 44/26/0587 DR REDDY S LABORATORIES 44/7.1/0612 SANOFI-AVENTIS SOUTH AFRICA 44/7.1/0613 SANOFI-AVENTIS SOUTH AFRICA 44/7.1/0614 SANOFI-AVENTIS SOUTH AFRICA 44/7.1/0615 SANOFI-AVENTIS SOUTH AFRICA 44/7.1/0634 SANOFI-AVENTIS SOUTH AFRICA 44/20.2.2/0639 ASTELLAS PHARMA (PTY) 44/20.2.2/0640 ASTELLAS PHARMA (PTY) IRNOCAM 40 IRNOCAM 100 CO RAMIWIN 2,5/12,5 mg CO RAMIWIN 5/12,5 mg CO RAMIWIN 5/25 mg CO RAMIWIN 10/12,5 mg CO RAMIWIN 10/25 mg MYCAMINE 50 MYCAMINE 100 HYDROCHLORIDE 10,0 mg Each 2,0 ml SOLUTION IRINOTECAN HYDROCHLORIDE TRIHYDRATE 40,0 mg Each 5,0 ml SOLUTION IRINOTECAN HYDROCHLORIDE TRIHYDRATE RAMIPRIL 2,5 mg 12,5 mg RAMIPRIL 5,0 mg 12,5 mg RAMIPRIL 5,0 mg 25,0 mg RAMIPRIL 10,0 mg 12,5 mg RAMIPRIL 10,0 mg 25,0 mg Each VIAL MICAFUNGIN SODIUM 50,0 mg Each VIAL MICAFUNGIN SODIUM 44/7.1.3/0883 PHARMACARE LIMITED ASPEN LOSARTAN 50 LOSARTAN POTASSIUM 50,0 mg 44/7.1.3/0884 PHARMACARE LIMITED ASPEN LOSARTAN 100 LOSARTAN POTASSIUM 44/3.2/1015 MSD MSD ALENDRONATE 5 600 44/2.7/1047 PHARMAPLAN TORAKET 10 mg TABLETS ALENDRONATE SODIUM ALENDRONIC ACID 70,0 mg CHLOLECALCIFEROL VITAMIN Dɜ 5 600 I.U. KETOROLAC TROMETAMOL 10,0 mg 44/20.1.1/1053 MSD MSD ERTAPENEM ERTAPENEM SODIUM 12.84_Notification_of Mar15_v1 April 2015 Page 3 of 6
45/26/0226 TEVA PHARMACEUTICALS 45/26/0227 TEVA PHARMACEUTICALS 45/26/0228 TEVA PHARMACEUTICALS 45/16.1/0231 ZYDUS HEALTHCARE SA 45/16.1/0232 ZYDUS HEALTHCARE SA 45/2.7/0443 BIOTECH LABORATORIES GEMCITABINE TEVA 200 GEMCITABINE TEVA 1 000 GEMCITABINE TEVA 2 000 METAZ MOISTURISING NASAL SPRAY OXYSPRAY MOISTURISING PARACETAMOL BIOTECH IV 45/5.2/0525 MYLAN MYLAN BISOPROLOL 5 mg 45/5.2/0526 MYLAN MYLAN BISOPROLOL 10 mg 45/20.1.1/0675 PHARMA DYNAMICS (PTY) DYNAFLOC IV ERTAPENEM 1,0 g Each VIAL GEMCITABINE HYDROCHLORIDE GEMCITABINE 200,0 mg Each VIAL GEMCITABINE HYDROCHLORIDE GEMCITABINE 1 000,0 mg Each VIAL GEMCITABINE HYDROCHLORIDE GEMCITABINE 2 000,0 mg Each 1,0 ml SOLUTION OXYMETAZOLINE HYDROCHLORIDE 0,5 mg Each 1,0 ml SOLUTION OXYMETAZOLINE HYDROCHLORIDE 0,5 mg Each 1,0 ml SOLUTION PARACETAMOL 10,0 mg 5,0 mg 10,0 mg Each 1,0 ml SOLUTION CIPROFLOXACIN LACTATE MONOHYDRATE CIPROFLOXACIN 2,0 mg 45/11.5/0681 NORGINE MOVICOL CHOCOLATE Each SACHETS MACROGOL (PEG) 3350 13,125 g SODIUM CHLORIDE 350,7 mg SODIUM BICARBONATE 178,5 g POTASSIUM CHLORIDE 31,7 mg 45/15.4/0688 ACTOR PHARMA (PTY) 45/20.1.1/0969 LEBASI PHARMACEUTICALS cc 45/20.1.1/0970 LEBASI PHARMACEUTICALS cc 45/11.5/1129 INGELHEIM BRIMOCT AZITHROMYCIN LEBASI 250 mg AZITHROMYCIN LEBASI 500 mg FORLAX Each 1,0 ml SOLUTION BRIMONIDINE TARTRATE 2,0 mg AZITHROMYCIN DIHYDRATE AZITHROMYCIN 250,0 mg AZITHROMYCIN DIHYDRATE AZITHROMYCIN 500,0 mg Each SACHET MACROGOL 10,0 g 12.84_Notification_of Mar15_v1 April 2015 Page 4 of 6
46/5.7.1/0107 ZYDUS HEALTHCARE 46/5.7.1/0108 ZYDUS HEALTHCARE ARZEP NASAL SPRAY AZELASTINE ZYDUS 0,14 mg 46/21.12/0157 PHARMACARE LIMITED ASPEN EXEMESTANE 25 mg Each METERED SPRAY AZELASTINE HYDROCHLORIDE 0,14 mg Each METERED SPRAY AZELASTINE HYDROCHLORIDE 0,14 mg EXEMESTANE 25,0 mg 46/13.11/0162 PHARMAPLAN DAPTA CREAM Each 1,0 g CREAM ADAPALENE 1,0 mg 46/7.1.3/0387 PHARMA DYNAMICS (PTY) 46/7.1.3/0388 PHARMA DYNAMICS (PTY) BISOPROLOL CO UNICORN 5/6,25 BISOPROLOL CO UNICORN 10/6,25 5,0 mg 6,25 mg 10,0 mg 6,25 mg 46/25.2/0420 ADCOCK INGRAM LIMITED TRIOMEL N4-600E Each 2 000,0 ml EMULSION REFINED OLIVE OIL 60,0 g AMINO ACIDS 50,6 g SODIUM ACETATE 2,31 g PHOSPHATE 5H 2 0 3,82 g POTASSIUM CHLORIDE 2,38 g MAGNESIUM CHLORIDE 0,90 g GLUCOSE 150,0 g CALCIUM CHLORIDE 0,59 g 46/25.2/0421 ADCOCK INGRAM LIMITED TRIOMEL N5-860E Each 500,0 ml EMULSION REFINED OLIVE OIL 60,0 g AMINO ACIDS 49,4 g SODIUM ACETATE 2,24 g PHOSPHATE 5H 2 0 5,51 g POTASSIUM CHLORIDE 3,35 g MAGNESIUM CHLORIDE 1,22 g GLUCOSE 171,50 g CALCIUM CHLORIDE 0,77 g 46/25.2/0422 ADCOCK INGRAM LIMITED TRIOMEL N7-960E Each 2 000,0 ml EMULSION REFINED OLIVE OIL 80,0 g AMINO ACIDS 8,86 g SODIUM ACETATE 2,99 g PHOSPHATE 5H 2 0 7,34 g POTASSIUM CHLORIDE 4,47 g 12.84_Notification_of Mar15_v1 April 2015 Page 5 of 6
MAGNESIUM CHLORIDE 1,62 g GLUCOSE 280,0 g CALCIUM CHLORIDE 1,03 g 46/25.2/0423 ADCOCK INGRAM LIMITED TRIOMEL N9-840E Each 2 000,0 ml EMULSION REFINED OLIVE OIL 80,0 g AMINO ACIDS 113,9 g SODIUM ACETATE 2,99 g PHOSPHATE 5H 2 0 7,34 g POTASSIUM CHLORIDE 4,47 g MAGNESIUM CHLORIDE 1,62 g GLUCOSE 220,0 g CALCIUM CHLORIDE 1,03 g 46/25.2/0424 ADCOCK INGRAM LIMITED TRIOMEL N7-960 Each 1 500,0 ml EMULSION REFINED OLIVE OIL 60,0 g AMINO ACIDS 6,4 g ACETATE 46,0 mmol GLUCOSE 10,0 g 46/25.2/0425 ADCOCK INGRAM LIMITED TRIOMEL N9-840 Each 1 000,0 ml EMULSION REFINED OLIVE OIL 40,0 g AMINO ACIDS 56,9 g ACETATE 40,0 mmol GLUCOSE 110,0 g 46/20.2.8/0757 HETERO DRUGS SA HEFTENAM EFAVIRENZ 600,0 mg EMTRICITABINE 200,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 48/20.2.8/0174 WINTHROP LAMIVUDINE WINTHROP 300 mg 48/20.1.1/0223 SPECPHARM LINEZOLID SPECPHARM 600 A40/16.5/0066 ADCOCK INGRAM LIMITED CIPACOL ANTI- INFLAMMATORY MOUTHWASH 11/17.1/09 NORBROOK LABORATORIES SA (PTY) CYFLOR INJECTION FOR CATTLE AND SWINE LAMIVUDINE 300,0 mg LINEZOLID 600,0 mg Each 15,0 ml SOLUTION BENZYDAMINE HYDROCHLORIDE 22,5 mg Each 1,0 ml SOLUTION FLORFENICOL 300,0 mg DR JC GOUWS REGISTRAR OF MEDICINES 12.84_Notification_of Mar15_v1 April 2015 Page 6 of 6