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) A05/11.5/08 A38/20.1.1/0406 MERIAL SOUTH AFRICA (PTY) SANOFI-AVENTIS GASTROGARD ORELOX 200 EACH SYRINGE OMEPRAZOLE 2,28 g CEFPODOXIME PROXETIL CEFPODOXIME 200,0 mg A39/7.1.3/0580 UNICHEM SA (PTY) RENICARD 50 50,0 mg A40/21.8.2/0112 A40/21.8.2/0113 NOVARTIS SOUTH AFRICA (PTY) NOVARTIS SOUTH AFRICA (PTY) ESTALIS SEQUI PLUS 50/140 ESTALIS SEQUI PLUS 50/250 EACH PACK 4 PHASE I PATCHES EACH OESTRADIOL 4,33 mg 4 PHASE II PATCHES EACH OESTRADIOL 0,620 mg NORETHISTERONE ACETATE 2,70 mg EACH PACK 4 PHASE I PATCHES EACH OESTRADIOL 4,33 mg 4 PHASE II PATCHES EACH OESTRADIOL 0,512 mg NORETHISTERONE ACETATE 4,80 mg 12.47 Notification of Jun09v2.doc July 2009 Page 1 of 7
A40/28/0210 AXIM PHARMACEUTICALS (PTY) ENTERO VU EACH 100,0 g POUCH BARIUM SULPHATE 81,0 g A40/18.8/0354 BAYER (PTY) YASMINELLE DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,02 mg A40/20.1.1/0368 A40/20.1.1/0369 A40/20.1.1/0370 A40/20.1.1/0371 A40/20.1.1/0372 A40/20.1.1/0373 A40/11.10/0481 A40/13.4.1/0666 A40/18.8/0693 A40/18.8/0743 RECKITT BENCKISER PHARMACEUTICALS (PTY) MERCK GENERICS RSA (PTY) PHARMA (PTY) PHARMA (PTY) 250 500 750 BIOFLOXX 250 BIOFLOXX 500 BIOFLOXX 750 GAVISCON COOLMINT LIQUID MOMETAGEN 0,1 % ORALCON TRIGESTREL 250,0 mg 500,0 mg 750,0 mg 250,0 mg 500,0 mg 750,0 mg EACH 10,0 ml SUSPENSION SODIUM ALGINATE 500,0 mg EACH 1,0 g CREAM MOMETASONE FUROATE 1,0 mg LEVONORGESTREL 0,15 mg ETHINYL ESTRADIOL 0,03 mg EACH PACK Six light brown tablets each containing: LEVONORGESTREL 50,0 µg ETHINYL ESTRADIOL 30,0 µg Five white tablets each containing: LEVONORGESTREL 75,0 µg ETHINYL ESTRADIOL 40,0 µg 12.47 Notification of Jun09v2.doc July 2009 Page 2 of 7
A40/18.8/0747 A40/20.2.8/0777 PHARMA (PTY) RANBAXY (S.A.) (PTY) 41/20.1.1/0043 AUROBINDO PHARMA (PTY) 41/20.1.1/0044 AUROBINDO PHARMA (PTY) 41/25.2/0060 FRESENIUS KABI SOUTH AFRICA (PTY) 41/20.2.2/0107 GULF DRUG COMPANY (PTY) 41/20.2.2/0124 GULF DRUG COMPANY (PTY) 41/11.3/0153 BOUWER BARTLETT (PTY) 41/7.1.3/0175 BOUWER BARTLETT (PTY) 41/11.3/0180 BOUWER BARTLETT (PTY) 41/20.2.2/0240 GULF DRUG COMPANY (PTY) 41/20.2.8/0248 AUROBINDO PHARMA (PTY) 41/21.1/0362 SANOFI-SYNTHELABO (PTY) 41/21.1/0363 SANOFI-SYNTHELABO (PTY) HY-AN SONKE-ABACAVIR 300 AUROPROZIL 250 mg AUROPROZIL 500 mg SMOFlipid 20 % GULF FLUCONAZOLE 200 GULF FLUCONAZOLE 150 GLENMARK CAPSULES 15 mg GLENMARK PERINDOPRIL TABLETS 4 mg GLENMARK CAPSULES 10 mg GULF FLUCONAZOLE 50 AURO ABACAVIR TABLETS 300 mg INSULIN GLARGINE WINTHROP INSULIN GLARGINE SANOFI-AVENTIS Ten yellow tablets each containing: LEVONORGESTREL 125,0 µg ETHINYL ESTRADIOL 30,0 µg Seven inert tablets LEVONORGESTREL 0,03 mg ABACAVIR SULPHATE ABACAVIR 300,0 mg CEFPROZIL MONOHYDRATE CEFPROZIL 250,0 mg CEFPROZIL MONOHYDRATE CEFPROZIL 500,0 mg EACH 1 000,0 ml SUSPENSION SOY OIL 60,0 g OLIVE OIL 50,0 g FISH OIL 30,0 g MEDIUM CHAIN TRIGLYCERIDES 60,0 g EACH CAPSULE FLUCONAZOLE 200,0 mg EACH CAPSULE FLUCONAZOLE 150,0 mg EACH CAPSULE MONOHYDRATE 15,0 mg PERINDOPRIL TERT- BUTYLAMINE 4,0 mg EACH CAPSULE MONOHYDRATE 10,0 mg EACH CAPSULE FLUCONAZOLE 50,0 mg ABACAVIR SULPHATE ABACAVIR 300,0 mg INSULIN GLARGINE 3,64 mg INSULIN GLARGINE 3,64 mg 12.47 Notification of Jun09v2.doc July 2009 Page 3 of 7
41/20.2.8/0386 AUROBINDO PHARMA (PTY) 41/5.7.2/0397 CIPLA MEDPRO (PTY) 41/5.7.2/0398 CIPLA MEDPRO (PTY) 41/5.7.2/0399 CIPLA LIFE SCIENCES (PTY) 41/5.7.2/0400 CIPLA LIFE SCIENCES (PTY) 41/8.4/0602 ADCOCK INGRAM 41/8.4/0603 ADCOCK INGRAM 41/2.5/0705 PHARMA (PTY) 41/2.5/0706 PHARMA (PTY) 41/2.5/0707 PHARMA (PTY) 41/2.5/0708 PHARMA (PTY) AURO ABACAVIR ORAL SOLUTION 20 mg/ml GRANICIP 1 mg GRANICIP 2 mg CIPLA 1 mg CIPLA 2 mg VITAHES VITAFUSAL LAMOTRIGINE 25 LAMOTRIGINE 50 LAMOTRIGINE 100 LAMOTRIGINE 200 ABACAVIR SULPHATE ABACAVIR 20,0 mg 1,0 mg 2,0 mg 1,0 mg 2,0 mg EACH 1 000,0 ml SOLUTION HYDROXYETHYL STARCH 130/0,42 60,0 g SODIUM CHLORIDE 9,0 g EACH 1 000,0 ml SOLUTION HYDROXYETHYL STARCH 130/0,42 60,0 g SODIUM CHLORIDE 6,0 g POTASSIUM CHLORIDE 0,4 g CALCIUM CHLORIDE DIHYDRATE 0,134 g MAGNESIUM CHLORIDE HEXAHYDRATE 0,2 g SODIUM ACETATE TRIHYDRATE 3,7 g LAMOTRIGINE 25,0 mg LAMOTRIGINE 50,0 mg LAMOTRIGINE 100,0 mg LAMOTRIGINE 200,0 mg 41/20.1.1/0721 PHARMACARE LIMITED ZEFURIME 250 mg CEFUROXIME AXETIL CEFUROXIME 250,0 mg 12.47 Notification of Jun09v2.doc July 2009 Page 4 of 7
41/20.1.1/0722 PHARMACARE LIMITED ZEFURIME 500 mg CEFUROXIME AXETIL CEFUROXIME 500,0 mg 41/21.8.2/0842 BAYER (PTY) YAZ DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,02 mg 41/21.5.1/0968 GLAXOSMITHKLINE AVAMYS EACH SPRAY FLUTICASONE FUROATE 27,5 µg 41/7.1.3/1070 SPECPHARM (PTY) NATRAZONE 25 25,0 mg 41/7.1.3/1071 SPECPHARM (PTY) NATRAZONE 50 50,0 mg 41/7.1.3/1072 SPECPHARM (PTY) NATRAZONE 100 100,0 mg 41/7.1.3/1073 SPECPHARM (PTY) NATRAZONE 12,5 12,5 mg 41/5.7.2/1079 ADCOCK INGRAM 41/5.7.2/1080 ADCOCK INGRAM 42/20.1.1/0204 AUROBINDO PHARMA (PTY) 42/20.1.1/0205 AUROBINDO PHARMA (PTY) ADCO 1 mg/1 ml ADCO 3 mg/3 ml AURO CEFALEXIN TABLETS 250 mg AURO CEFALEXIN TABLETS 750 mg 42/20.1.1/0509 PHARMACARE LIMITED ASPEN 250 mg 42/20.1.1/0510 PHARMACARE LIMITED ASPEN 500 mg 42/26/0528 PHARMACARE LIMITED ASPEN 10 mg/5 ml 1,0 mg EACH 3,0 ml SOLUTION 3,0 mg CEFALEXIN MONOHYDRATE CEFALEXIN 250,0 mg CEFALEXIN MONOHYDRATE CEFALEXIN 750,0 mg HEMIHYDRATE EQUIVALENT TO 250,0 mg HEMIHYDRATE EQUIVALENT TO 500,0 mg EACH 5,0 ml SOLUTION 10,0 mg 12.47 Notification of Jun09v2.doc July 2009 Page 5 of 7
42/26/0529 PHARMACARE LIMITED ASPEN 20 mg/10 ml 42/26/0530 PHARMACARE LIMITED ASPEN 50 mg/25 ml 42/26/0531 PHARMACARE LIMITED ASPEN 100 mg/50 ml 42/26/0532 PHARMACARE LIMITED ASPEN 200 mg/100 ml 42/20.1.1/0601 AUROBINDO PHARMA (PTY) 42/20.1.1/0602 AUROBINDO PHARMA (PTY) 42/20.1.1/0603 AUROBINDO PHARMA (PTY) 42/20.1.1/0604 AUROBINDO PHARMA (PTY) 42/11.3/0628 RANBAXY (S.A.) (PTY) 42/11.3/0629 RANBAXY (S.A.) (PTY) 42/21.2/0702 ARROW PHARMA 42/21.2/0703 ARROW PHARMA 42/21.2/0704 ARROW PHARMA 42/21.2/0705 ARROW PHARMA 250 mg 500 mg 1 000 mg 2 000 mg RAN 10 RAN 15 AROGLIM 1 mg AROGLIM 2 mg AROGLIM 3 mg AROGLIM 4 mg EACH 10,0 ml SOLUTION 20,0 mg EACH 25,0 ml SOLUTION 50,0 mg EACH 50,0 ml SOLUTION 100,0 mg EACH 100,0 ml SOLUTION 200,0 mg EACH VIAL CEFOTAXIME 250,0 mg EACH VIAL CEFOTAXIME 500,0 mg EACH VIAL CEFOTAXIME 1 000,0 mg EACH VIAL CEFOTAXIME 2 000,0 mg EACH CAPSULE MONOHYDRATE 10,0 mg EACH CAPSULE MONOHYDRATE 15,0 mg GLIMEPIRIDE 1,0 mg GLIMEPIRIDE 2,0 mg GLIMEPIRIDE 3,0 mg GLIMEPIRIDE 4,0 mg 12.47 Notification of Jun09v2.doc July 2009 Page 6 of 7
42/21.2/0706 ARROW PHARMA 42/21.2/0707 ARROW PHARMA 42/21.2/0708 ARROW PHARMA 42/21.2/0709 ARROW PHARMA 42/1.2/0718 ARROW PHARMA 42/1.2/0719 ARROW PHARMA 44/26/0024 ACCORD HEALTHCARE (PTY) 44/26/0025 ACCORD HEALTHCARE (PTY) 1 mg 2 mg 3 mg 4 mg ARROW CITALOPRAM 40 mg ARROW CITALOPRAM 20 mg IRINOTAS 100 ACCORD IRINOTECAN 100 GLIMEPIRIDE 1,0 mg GLIMEPIRIDE 2,0 mg GLIMEPIRIDE 3,0 mg GLIMEPIRIDE 4,0 mg CITALOPRAM HYDROBROMIDE CITALOPRAM 40,0 mg CITALOPRAM HYDROBROMIDE CITALOPRAM 20,0 mg EACH 5,0 ml VIAL IRINOTECAN 100,0 mg EACH 5,0 ml VIAL IRINOTECAN 100,0 mg MS MANDISA HELA REGISTRAR OF MEDICINES 12.47 Notification of Jun09v2.doc July 2009 Page 7 of 7