MEDICINES CONTROL COUNCIL

Notification of of Medicines 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) 33/2.9/0498 PHARMACHEMIE (PTY) 33/2.9/0499 PHARMACHEMIE (PTY) 33/2.9/0500 PHARMACHEMIE (PTY) 33/2.9/0501 PHARMACHEMIE (PTY) 38/34/0031 STRIDES SA A39/23/0180 FRESENIUS KABI SOUTH AFRICA PCH CR 10 PCH CR 30 PCH CR 60 PCH CR 100 DAS FLUMAZENIL 0,1 mg/ml AMINOVEN 5 % 30,0 mg 60,0 mg 100,0 mg Each 1,0 ml solution contains: FLUMAZENIL 0,1 mg Each 1 000,0 ml solution contains: L-ISOLEUCINE 2,5 g L-LEUCINE 3,7 g L-METHIONINE 2,15 g L-LYSINE ACETATE equivalent to L-LYSINE 4,655 g L-PHENYLALANINE 2,55 g L-THREONINE 2,2 g L-TRYPTOPHAN 1,0 g L-VALINE 3,1 g L-ARGININE 6,0 g L-HISTIDINE 1,5 g L-ALANINE 7,0 g GLYCINE 5,5 g L-PROLINE 5,6 g L-SERINE 3,25 g L-TYROSINE 0,2 g TAURINE 0,5 g 12.68_Notification_of Sep12_v1 Oct 2012 Page 1 of 10

A39/23/0181 A39/23/0183 A40/20.2.2/0437 A40/20.2.2/0438 FRESENIUS KABI SOUTH AFRICA FRESENIUS KABI SOUTH AFRICA ZYDUS HEALTHCARE SA ZYDUS HEALTHCARE SA AMINOVEN 10 % AMINOVEN 15 % ZYDUS FLUCONAZOLE 150 mg ZYDUS FLUCONAZOLE 200 mg Notification of of Medicines Each 1 000,0 ml solution contains: L-ISOLEUCINE 5,0 g L-LEUCINE 7,4 g L-METHIONINE 4,3 g L-LYSINE ACETATE equivalent to L-LYSINE 9,31 g L-PHENYLALANINE 5,1 g L-THREONINE 4,4 g L-TRYPTOPHAN 2,0 g L-VALINE 6,2 g L-ARGININE 12,0 g L-HISTIDINE 3,0 g L-ALANINE 14,0 g GLYCINE 11,0 g L-PROLINE 11,2 g L-SERINE 6,5 g L-TYROSINE 0,4 g TAURINE 1,0 g Each 1 000,0 ml solution contains: L-ISOLEUCINE 5,2 g L-LEUCINE 8,9 g L-METHIONINE 3,8 g L-LYSINE ACETATE equivalent to L-LYSINE 15,655 g L-PHENYLALANINE 5,5 g L-THREONINE 8,6 g L-TRYPTOPHAN 1,6 g L-VALINE 5,5 g L-ARGININE 20,0 g L-HISTIDINE 7,3 g L-ALANINE 25,0 g GLYCINE 18,5 g L-PROLINE 17,0 g L-SERINE 9,6 g L-TYROSINE 0,4 g TAURINE 2,0 g FLUCONAZOLE 150,0 mg FLUCONAZOLE 200,0 mg 41/21.2/0354 MSD JANUVIA 25 SITAGLIPTIN PHOSPATE SITAGLIPTIN 25,0 mg 41/21.2/0355 MSD JANUVIA 50 SITAGLIPTIN PHOSPATE SITAGLIPTIN 50,0 mg 12.68_Notification_of Sep12_v1 Oct 2012 Page 2 of 10

Notification of of Medicines 41/21.2/0356 MSD JANUVIA 100 SITAGLIPTIN PHOSPATE SITAGLIPTIN 100,0 mg 42/11.10/0263 RECKITT BENCKISER 42/26/0327 ACCORD HEALTHCARE 42/26/0328 ACCORD HEALTHCARE 42/26/0329 ACCORD HEALTHCARE GAVISCON PLUS TABLETS ACCORD MIDAZOLAM 15 mg/3 ml ACCORD MIDAZOLAM 50 mg/10 ml ACCORD MIDAZOLAM 5 mg/5 ml SODIUM ALGINATE 250,0 mg SODIUM BICARBONATE 106,5 mg CALCIUM CARBONATE 187,5 mg Each 3,0 ml solution contains: MIDAZOLAM 15,0 mg Each 10,0 ml solution contains: MIDAZOLAM 50,0 mg Each 5,0 ml solution contains: MIDAZOLAM 5,0 mg 42/11.5/0408 NORGINE MACROLYTE Each sachet of powder contains: POLYETHYLENE GLYCOL 3 350 13,125 g SODIUM BICARBONATE 178,5 mg SODIUM CHLORIDE 350,07 mg POTASSIUM CHLORIDE 46,6 mg 42/11.5/0409 NORGINE ISOPEG Each sachet of powder contains: POLYETHYLENE GLYCOL 3 350 13,125 g SODIUM BICARBONATE 178,5 mg SODIUM CHLORIDE 350,07 mg POTASSIUM CHLORIDE 46,6 mg 42/20.2/0567 BIOTECH LABORATORIES (PTY) 42/5.2/0847 ZYDUS HEALTHCARE SA 42/5.2/0848 ZYDUS HEALTHCARE SA BIO METRONIDAZOLE IV BISOPROLOL ZYDUS 5 TABLETS BISOPROLOL ZYDUS 10 TABLETS 42/20.1.1/1002 PHARMACARE LIMITED ASPEN LEVOFLOXACIN 5 mg/ml 42/26/1065 ACCORD HEALTHCARE 42/26/1066 ACCORD HEALTHCARE 42/7.1.5/1070 PHARMA DYNAMICS ACCORD OXALIPLATIN 100 INTAS OXALIPLATIN 100 DYNAFIL 25 mg Each 100,0 ml solution contains: METRONIDAZOLE 500,0 mg 5,0 mg Each 1,0 ml contains: LEVOFLOXACIN HEMIHYDRATE 5,0 mg OXALIPLATIN 100,0 mg OXALIPLATIN 100,0 mg SILDENAFIL CITRATE SILDENAFIL 25,0 mg 12.68_Notification_of Sep12_v1 Oct 2012 Page 3 of 10

42/7.1.5/1071 PHARMA DYNAMICS 42/7.1.5/1072 PHARMA DYNAMICS DYNAFIL 50 mg DYNAFIL 100 mg Notification of of Medicines SILDENAFIL CITRATE SILDENAFIL 50,0 mg SILDENAFIL CITRATE SILDENAFIL 100,0 mg 42/21.2/1089 MSD JANUMET 50/500 SITAGLIPTIN PHOSPHATE SITAGLIPTIN 50,0 mg METFORMIN HYDROCHLORIDE 500,0 mg 42/21.2/1090 MSD JANUMET 50/850 SITAGLIPTIN PHOSPHATE SITAGLIPTIN 50,0 mg METFORMIN HYDROCHLORIDE 850,0 mg 42/21.2/1091 MSD JANUMET 50/1 000 SITAGLIPTIN PHOSPHATE SITAGLIPTIN 50,0 mg METFORMIN HYDROCHLORIDE 1 000,0 mg 42/20.1.1/1098 STRIDES SA (PTY ) STRIDES AZITHROMYCIN 500 mg 43/21.12/0010 MEDIVISION MEDIVISION ANASTROZOLE 1 43/7.1.3/0059 ZYDUS HEALTHCARE SA 43/7.1.3/0060 ZYDUS HEALTHCARE SA 43/7.1.3/0061 ZYDUS HEALTHCARE SA 43/20.1.1/0245 ORCHID SA 43/2.2/0248 AUROBINDO PHARMA BISOPROLOL HYDROCHLORO- THIAZIDE ZYDUS 2,5/6,25 TABLETS BISOPROLOL HYDROCHLORO- THIAZIDE ZYDUS 5/6,25 TABLETS BISOPROLOL HYDROCHLORO- THIAZIDE ZYDUS 10/6,25 TABLETS ORCHID CEFPODOXIME 40 mg/5 ml AURO ZOLPIDEM 10 mg AZITHROMYCIN MONOHYDRATE AZITHROMYCIN 500,0 mg ANASTROZOLE 1,0 mg 2,5 mg 5,0 mg Each 5,0 ml suspension contains: CEFPODOXIME PROXETIL CEFPODOXIME 40,0 mg ZOLPIDEM TARTRATE 12.68_Notification_of Sep12_v1 Oct 2012 Page 4 of 10

43/2.2/0258 AUROBINDO PHARMA 43/1.2/0273 BE-TABS 43/1.2/0274 RANBAXY (SA) (PTY) 43/1.2/0275 BE-TABS 43/1.2/0276 RANBAXY (SA) (PTY) 43/1.2/0312 PHARMA DYNAMICS 43/1.2/0313 PHARMA DYNAMICS 43/1.2/0314 PHARMA DYNAMICS 43/1.2/0315 PHARMA DYNAMICS AURO ZOLPIDEM 5 mg BESIT 10 EPRALIFE 10 BESIT 20 EPRALIFE 20 DYNA ESCITALOPRAM 5 mg DYNA ESCITALOPRAM 10 mg DYNA ESCITALOPRAM 15 mg DYNA ESCITALOPRAM 20 mg Notification of of Medicines ZOLPIDEM TARTRATE 5,0 mg ESCITALOPRAM ESCITALOPRAM ESCITALOPRAM 20,0 mg ESCITALOPRAM 20,0 mg ESCITALOPRAM 5,0 mg ESCITALOPRAM ESCITALOPRAM 15,0 mg ESCITALOPRAM 20,0 mg 43/20.1.8/0388 PHARMACARE LIMITED VAVIREX 500 VALACICLOVIR HYDROCHLORIDE equivalent to VALACICLOVIR 500,0 mg 43/11.4.3/0483 SANDOZ SA TOPRALOC 20 PANTOPRAZOLE SODIUM SESQUIHYDRATE PANTOPRAZOLE 20,0 mg 43/11.4.3/0484 SANDOZ SA TOPRALOC 40 PANTOPRAZOLE SODIUM SESQUIHYDRATE PANTOPRAZOLE 40,0 mg 43/11.4.3/0485 SANDOZ SA HEXAL PANTOPRAZOLE 20 43/11.4.3/0486 SANDOZ SA HEXAL PANTOPRAZOLE 40 PANTOPRAZOLE SODIUM SESQUIHYDRATE PANTOPRAZOLE 20,0 mg PANTOPRAZOLE SODIUM SESQUIHYDRATE PANTOPRAZOLE 40,0 mg 12.68_Notification_of Sep12_v1 Oct 2012 Page 5 of 10

43/7.1/0558 BIOTECH LABORATORIES (PTY) 43/7.1/0559 BIOTECH LABORATORIES (PTY) BIO NIFEDIPINE XL 30 BIO NIFEDIPINE XL 60 Notification of of Medicines NIFEDIPINE 30,0 mg NIFEDIPINE 60,0 mg 43/2.6.5/0593 PHARMAPLAN ZOQIT 25 QUETIAPINE FUMARATE QUETIAPINE 25,0 mg 43/2.6.5/0594 PHARMAPLAN ZOQIT 100 QUETIAPINE FUMARATE QUETIAPINE 100,0 mg 43/2.6.5/0595 PHARMAPLAN ZOQIT 200 QUETIAPINE FUMARATE QUETIAPINE 200,0 mg 43/2.6.5/0596 PHARMAPLAN ZOQIT 300 QUETIAPINE FUMARATE QUETIAPINE 300,0 mg 43/13.1/0673 BARRS PHARMACEUTICAL INDUSTRIES cc 43/13.1/0674 BARRS PHARMACEUTICAL INDUSTRIES cc 43/2.2/0819 DR REDDY S LABORATORIES (PTY) 43/5.7.1/0912 SCHERING-PLOUGH 43/20.1.1/1087 CIPLA MEDPRO (PTY) 43/20.1.1/1088 CIPLA LIFE SCIENCES STERISCRUB STERISOL DRL ZOLPIDEM 10 DESELEX D-12 MEDPRO VANCOMAX 500 CIPLA VANCOMYCIN Each 100,0 ml solution contains: CHLORHEXIDINE GLUCONATE 20 % SOLUTION 20,0 ml Each 100,0 ml solution contains: CHLORHEXIDINE GLUCONATE 20 % SOLUTION 2,50 ml ZOLPIDEM TARTRATE DESLORATADINE 2,5 mg PSEUDOEPHEDRINE SULPHATE 120,0 mg VANCOMYCIN HCl equivalent to VANCOMYCIN 500,0 mg VANCOMYCIN HCl equivalent to VANCOMYCIN 500,0 mg 43/2.5/1142 PHARMAPLAN TOPIROL 50 TOPIRAMATE 50,0 mg 43/26/1171 CIPLA MEDPRO (PTY) 43/26/1172 CIPLA MEDPRO (PTY) ONCOGEM 200 ONCOGEM 1 000 GEMCITABINE HYDROCHLORIDE equivalent to GEMCITABINE 200,0 mg GEMCITABINE HYDROCHLORIDE equivalent to GEMCITABINE 1 000,0 mg 12.68_Notification_of Sep12_v1 Oct 2012 Page 6 of 10

Notification of of Medicines 44/2.9/0113 PHARMAPLAN DEPODUR 10 PENTAHYDRATE 44/21.12/0281 CIPLA MEDPRO (PTY) 44/21.12/0282 CIPLE LIFE SCIENCES MEDPRO LETROZOLE 2,5 CIPLA LETROZOLE 2,5 LETROZOLE 2,5 mg LETROZOLE 2,5 mg 44/3.1/0331 NYCOMED XEFO RAPID LORNOXICAM 8,0 mg 44/26/0380 ACCORD HEALTHCARE 44/26/0381 ACCORD HEALTHCARE 44/2.6.5/0447 AKACIA HEALTHCARE 44/2.6.5/0448 AKACIA HEALTHCARE 44/2.6.5/0449 AKACIA HEALTHCARE 44/2.6.5/0450 AKACIA HEALTHCARE 44/2.6.5/0451 AKACIA HEALTHCARE 44/2.6.5/0452 AKACIA HEALTHCARE 44/2.6.5/0453 AKACIA HEALTHCARE 44/2.6.5/0454 AKACIA HEALTHCARE 44/7.1.3/0477 RANBAXY (SA) (PTY) 44/7.1.3/0478 RANBAXY (SA) (PTY) 44/7.1.3/0479 RANBAXY (SA) (PTY) 44/7.1.3/0482 RANBAXY (SA) (PTY) 44/7.1.3/0483 RANBAXY (SA) (PTY) INTAS OXALIPLATIN 50 ACCORD OXALIPLATIN 50 ZYLENA 5 ZYLENA 10 ZYLENA 15 ZYLENA 20 ZYLENA ODT 5 ZYLENA ODT 10 ZYLENA ODT 15 ZYLENA ODT 20 DIOLO CO PLUS 160/25 DIOLO CO 80/12,5 DIOLO CO 160/12,5 VALSARTAN RAN CO 160/25 VALSARTAN RAN CO 80/12,5 OXALIPLATIN 50,0 mg OXALIPLATIN 50,0 mg OLANZAPINE 5,0 mg OLANZAPINE OLANZAPINE 15,0 mg OLANZAPINE 20,0 mg OLANZAPINE 5,0 mg OLANZAPINE OLANZAPINE 15,0 mg OLANZAPINE 20,0 mg VALSARTAN 160,0 mg 25,0 mg VALSARTAN 80,0 mg 12,5 mg VALSARTAN 160,0 mg 12,5 mg VALSARTAN 160,0 mg 25,0 mg VALSARTAN 80,0 mg 12,5 mg 12.68_Notification_of Sep12_v1 Oct 2012 Page 7 of 10

44/7.1.3/0484 RANBAXY (SA) (PTY) 44/7.1.3/0560 RANBAXY (SA) (PTY) 44/7.1.3/0561 RANBAXY (SA) (PTY) 44/7.1.3/0562 RANBAXY (SA) (PTY) 44/7.1.3/0563 RANBAXY (SA) (PTY) 44/7.1.3/0564 RANBAXY (SA) (PTY) 44/7.1.3/0565 RANBAXY (SA) (PTY) VALSARTAN RAN CO 160/12,5 ZIRINAK 2,5/6,25 ZIRINAK 5/6,25 ZIRINAK 10/6,25 RAN BISOPROLOL CO 2,5/6,25 RAN BISOPROLOL CO 5/6,25 RAN BISOPROLOL CO 10/6,25 44/11.4.3/0595 SANDOZ SA SANDOZ RABEPRAZOLE 10 44/11.4.3/0596 SANDOZ SA SANDOZ RABEPRAZOLE 20 Notification of of Medicines VALSARTAN 160,0 mg 12,5 mg 2,5 mg 5,0 mg 2,5 mg 5,0 mg RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM 20,0 mg 44/11.4.3/0597 SANDOZ SA RABEMED 10 RABEPRAZOLE SODIUM 44/11.4.3/0598 SANDOZ SA RABEMED 20 RABEPRAZOLE SODIUM 20,0 mg 44/21.2/0794 ALKEM LABORATORIES 44/21.2/0795 ALKEM LABORATORIES 44/7.1.3/0906 BRIMPHARM SA (PTY) METFORM ALKEM 500 METFORM ALKEM 850 IRTANEL 75 METFORMIN HYDROCHLORIDE 500,0 mg METFORMIN HYDROCHLORIDE 850,0 mg IRBESARTAN 75,0 mg 12.68_Notification_of Sep12_v1 Oct 2012 Page 8 of 10

44/7.1.3/0907 BRIMPHARM SA (PTY) 44/7.1.3/0908 BRIMPHARM SA (PTY) 44/7.1.3/0909 BRIMPHARM SA (PTY) 44/7.1.3/0910 BRIMPHARM SA (PTY) 44/7.1.3/0911 BRIMPHARM SA (PTY) 44/20.2.2/0932 JANSSEN PHARMACEUTICA (PTY) 44/1.2/1005 ZYDUS HEALTHCARE SA 44/1.2/1006 ZYDUS HEALTHCARE SA 44/1.2/1007 ZYDUS HEALTHCARE SA 44/1.2/1008 ZYDUS HEALTHCARE SA 44/20.2.8/1026 MACLEODS SA 44/20.2.8/1027 MACLEODS SA 44/20.2.8/1028 MACLEODS SA IRTANEL 150 IRTANEL 300 IRBESARTAN BRIMPHARM 75 IRBESARTAN BRIMPHARM 150 IRBESARTAN BRIMPHARM 300 DAK-O-GEL MIRTAZAPINE ZYDUS 15 mg MIRTAZAPINE ZYDUS 30 mg MIRADEP 15 mg MIRADEP 30 mg ROSTAV 15 ROSTAV 20 ROSTAV 30 Notification of of Medicines IRBESARTAN 150,0 mg IRBESARTAN 300,0 mg IRBESARTAN 75,0 mg IRBESARTAN 150,0 mg IRBESARTAN 300,0 mg Each 1,0 g gel contains: MICONAZOLE 20,0 mg MIRTAZAPINE 15,0 mg MIRTAZAPINE 30,0 mg MIRTAZAPINE 15,0 mg MIRTAZAPINE 30,0 mg STAVUDINE 15,0 mg STAVUDINE 20,0 mg STAVUDINE 30,0 mg 44/20.2.8/1051 PHARMACARE LIMITED TENARENZ TENOFOVIR DISOPROXIL FUMARATE 300,0 mg LAMIVUDINE 300,0 mg EFAVIRENZ 600,0 mg 44/2.9/1087 PHARMAPLAN DEPODUR 15 PENTAHYDRATE 15,0 mg 44/2.9/1088 PHARMAPLAN DEPODUR 20 PENTAHYDRATE 20,0 mg 45/5.7.2/0067 TEVA 45/5.7.2/0068 TEVA 45/20.2.8/0108 CIPLA MEDPRO (PTY) GRANISETRON TEVA 1 GRANISETRON TEVA 3 CIPLA LAMIVUDINE & TENOFOVIR 300/300 Each 1,0 ml solution contains: GRANISETRON HYDROCHLORIDE equivalent to GRANISETRON 1,0 mg Each 3,0 ml solution contains: GRANISETRON HYDROCHLORIDE equivalent to GRANISETRON 3,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg LAMIVUDINE 300,0 mg 12.68_Notification_of Sep12_v1 Oct 2012 Page 9 of 10

45/20.2.8/0109 CIPLA LIFE SCIENCES 45/26/0145 CIPLA MEDPRO (PTY) 45/26/0146 CIPLA LIFE SCIENCES 45/8.2/0162 INGELHEIM 45/32.2/0540 BAROQUE 45/10.2.2/0744 CAMOX 45/10.2.2/0745 CAMOX 45/20.2.8/0887 MACLEODS SA MEDPRO LAMIVUDINE & TENOFOVIR 300/300 PURIDA CIPLA FLUDARABINE PRADAXA 150 XIENCE XPEDITION BELAIR 4 mg BELAIR 5 mg MACLEODS STAVUDINE 30 mg 45/20.2.8/0926 MYLAN MYLAN EMTRICITABINE 200 mg Notification of of Medicines TENOFOVIR DISOPROXIL FUMARATE 300,0 mg LAMIVUDINE 300,0 mg FLUDARABINE 50,0 mg FLUDARABINE 50,0 mg DABIGATRAN ETEXILATE MESILATE DABIGATRAN ETEXILATE 150,0 mg Each stent contains: EVEROLIMUS 100,0 µg/cm 2 Each chewable tablet contains: MONTELUKAST SODIUM MONTELUKAST 4,0 mg Each chewable tablet contains: MONTELUKAST SODIUM MONTELUKAST 5,0 mg STAVUDINE 30,0 mg EMTRICITABINE 200,0 mg 46/20.2.8/0006 MYLAN KAVIMUN PAED ABACAVIR SULPHATE ABACAVIR 60,0 mg 46/20.2.8/0008 MYLAN ZIDOMAT 100 mg ZIDOVUDINE 100,0 mg 46/20.2.8/0009 MYLAN ZIDOMAT 300 mg ZIDOVUDINE 300,0 mg 46/34/0023 NOVARTIS SA GILENYA 0,5 mg FINGOLIMOD HYDROCHLORIDE 0,5 mg MS MANDISA HELA REGISTRAR OF MEDICINES 12.68_Notification_of Sep12_v1 Oct 2012 Page 10 of 10