MEDICINES CONTROL COUNCIL
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1 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) 08/5.1/09 INGELHEIM 08/5.1/10 INGELHEIM A39/23/0594 FRESENIUS KABI SOUTH AFRICA VETMEDIN 1,25 mg VETMEDIN 5 mg AMINOVEN 3,5% GE PIMOBENDAN 1,25 mg PIMOBENDAN 5,0 mg Each 1 000,0 ml solution TOTAL AMINO ACIDS 35,0 g L-isoleucine 1,75 g L-leucine 2,59 g L-methionine 1,505 g L-lysine 2,31 g L-phenylalanine 1,785 g L-threonine 1,54 g L-tryptophan 0,70 g L-valine 2,17 g L-arginine 4,20 g L-histidine 1,05 g L-alanine 4,90 g Glycine 3,85 g L-proline 3,92 g L-serine 2,275 g Taurine 0,35 g Sodium Chloride 1,169 g Calcium Chloride 0,222 g Magnesium Chloride 0,286 g Zinc Chloride 0,00545 g Potassium Hydroxide 1,98 g Sodium glycerophosphate 3,241 g Glucose Monohydrate 55,0 g A40/11.4.3/0192 PHARMACARE LIMITED ALTOSEC 40 mg/10 ml Each vial OMEPRAZOLE 40,0 mg Notification of Jun10v1.doc July 2010 Page 1 of 5
2 A40/34/0431 PHARMACARE LIMITED ALTOSEC SOLVENT FOR INJECTABLE SOLUTION A40/7.1.3/0685 SPECPHARM SPEC CARVEDILOL 6,25 A40/7.1.3/0686 SPECPHARM SPEC CARVEDILOL 12,5 Each ampoule WATER FOR INJECTIONS 10,0 ml CARVEDILOL 6,25 mg CARVEDILOL 12,5 mg A40/7.1.3/0687 SPECPHARM SPEC CARVEDILOL 25 CARVEDILOL 25,0 mg A40/14.2/0698 BRISTOL-MYERS SQUIBB 41/8.1/0223 PHARMAFRICA (PTY) 41/7.3/0369 DR REDDY S LABORATORIES (PTY) 41/7.3/0370 DR REDDY S LABORATORIES (PTY) 41/21.2/0487 NOVARTIS SOUTH AFRICA 41/20.3/0719 SCHERING-PLOUGH 41/3.1/0996 STRIDES SA 41/3.1/0997 STRIDES SA 41/3.1/1085 STRIDES SA 42/5.8/0099 JOHNSON & JOHNSON 42/34/0514 SAFELINE 42/20.2.8/0538 AUROBIND PHARMA 42/20.2.8/0539 AUROBIND PHARMA 42/20.2.8/0540 AUROBIND PHARMA AQUACEL-AG WITH HYDROFIBER GOLDSHIELD TRANEXAMIC ACID 500 mg MEGAN 50 MEGAN 100 GALVUS 50 mg NOXAFIL 40 mg/ml KETOJECT 15 mg/1 ml KETOJECT 60 mg/2 ml KETOJECT 30 mg/1 ml SUDAFED PE SINUS DECONGESTANT SOLVENT FOR OMEPRAZOLE SAFELINE INJECTION 40 mg 50 mg 100 mg 200 mg Each 100,0 g of dressing SODIUM SILVER CARBOXYMETHYL- CELLULOSE 100,0 g TRANEXAMIC ACID 500,0 mg SUMATRIPTAN 50,0 mg SUMATRIPTAN 100,0 mg VILDAGLIPTIN 50,0 mg Each 1,0 ml suspension POSACONAZOLE 40,0 mg Each 1,0 ml solution TROMETHAMINE 15,0 mg Each 1,0 ml solution TROMETHAMINE 30,0 mg Each 1,0 ml solution TROMETHAMINE 30,0 mg PHENYLEPHRINE 10,0 mg Each vial WATER FOR INJECTION Each capsule EFAVIRENZ 50,0 mg Each capsule EFAVIRENZ 100,0 mg Each capsule EFAVIRENZ 200,0 mg Notification of Jun10v1.doc July 2010 Page 2 of 5
3 42/21.5.4/0581 GROUP LABORATORIES 42/21.5.4/0582 GROUP LABORATORIES 42/21.5.4/0583 GROUP LABORATORIES 42/21.5.4/0584 GROUP LABORATORIES 42/21.5.4/0585 GROUP LABORATORIES 42/21.5.4/0586 GROUP LABORATORIES 42/20.1.1/0636 RANBAXY (S.A.) (PTY) 42/20.1.1/0637 RANBAXY (S.A.) (PTY) 42/26/0758 TEVA 42/26/0759 TEVA FOXAIR 50/100 FOXAIR 50/250 FOXAIR 50/500 SALMEFLUT 50/100 SALMEFLUT 50/250 SALMEFLUT 50/500 BACQURE 500 CILAPEN 500 TEVA VINORELBINE 10 TEVA VINORELBINE 50 Each blister 100,0 µg Each blister 250,0 µg Each blister 500,0 µg Each blister 100,0 µg Each blister 250,0 µg Each blister 500,0 µg Each vial IMIPENEM 500,0 mg CILASTATIN SODIUM CILASTATIN 500,0 mg Each vial IMIPENEM 500,0 mg CILASTATIN SODIUM CILASTATIN 500,0 mg Each vial VINORELBINE TARTRATE VINORELBINE 10,0 mg Each vial VINORELBINE TARTRATE VINORELBINE 50,0 mg Notification of Jun10v1.doc July 2010 Page 3 of 5
4 42/20.2.8/0987 AUROBIND PHARMA ZYNOVIR ORAL SOLUTION 50 mg/5 ml Each 5,0 ml solution ZIDOVUDINE 50,0 mg 43/20.2.8/0181 PHARMACARE LIMITED ASPEN TENOFOVIR 43/11.3/0192 GROUP LABORATORIES 43/5.4.1/0216 ZYDUS HEALTHCARE SA 43/5.4.1/0217 ZYDUS HEALTHCARE SA 43/5.4.1/0218 ZYDUS HEALTHCARE SA 43/5.4.1/0219 ZYDUS HEALTHCARE SA 43/5.4.1/0220 ZYDUS HEALTHCARE SA 43/8.2/0242 ELI LILLY (S.A.) (PTY) 43/8.2/0243 ELI LILLY (S.A.) (PTY) 43/20.2.8/0287 AUROBINDO PHARMA 43/20.2.8/0356 ABBOTT LABORATORIES S.A. 43/20.2.8/0385 ADCOCK INGRAM LIMITED ALLI RESURE 0,25 RESURE 0,5 RESURE 1,0 RESURE 2,0 RESURE 5,0 EFIENT 5 mg EFIENT 10 mg BINDOPIN SUSPENSION 50 mg/5 ml ALUVIA 100/25 ABAVAID Each capsule ORLISTAT 60,0 mg RIPINIROLE 0,25 mg RIPINIROLE 0,5 mg RIPINIROLE 1,0 mg RIPINIROLE 2,0 mg RIPINIROLE 5,0 mg PRASUGREL PRASUGREL 5,0 mg PRASUGREL PRASUGREL 10,0 mg Each 5,0 ml suspension NEVIRAPINE 50,0 mg LOPINAVIR 100,0 mg RITONAVIR 25,0 mg ABACAVIR SULPHATE Notification of Jun10v1.doc July 2010 Page 4 of 5
5 43/20.2.8/0386 ADCOCK INGRAM LIMITED 43/30.2/0401 GLAXOSMITHKLINE ADCO ABACAVIR SYNFLORIX ABACAVIR SULPHATE Each 0,5 ml dose POLYSACCHARIDE FOR SEROTYPES: 1; 5; 6B; 7F; 9V; 14; 23F 1,0 µg 4; 18CV; 19F 3,0 µg 43/20.2.8/0724 PHARMACARE LIMITED ASPEN ABACAVIR /20.2.8/1102 PHARMACARE LIMITED AP LAMIVUDINE 150 mg 44/20.2.8/0086 AUROBIND PHARMA 44/20.2.8/0087 AUROBIND PHARMA 44/20.2.8/0344 RANBAXY (S.A.) (PTY) 44/20.2.8/0345 RANBAXY (S.A.) (PTY) 44/20.2.8/0445 CIPLA LIFE SCIENCES 44/20.2.8/0446 CIPLA MEDPRO (PTY) TYRICTEN 200/300 mg EMTRICITABINE/TENO FOVIR AURO 200/300 mg SONKE DIDANOSINE 250 SONKE DIDANOSINE 400 CIPLA TENOFOVIR/EMTRICIT ABINE DIDIVIR LAMIVUDINE 150,0 mg Each capsule DIDANOSINE 250,0 mg Each capsule DIDANOSINE 400,0 mg REGISTRAR OF MEDICINES MS MANDISA HELA Notification of Jun10v1.doc July 2010 Page 5 of 5
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