MEDICINES CONTROL COUNCIL

Notification of of Medicines MEDICINES CONTROL COUNCIL NOTIFICATION OF REGISTRATION OF MEDICINES IN JUNE 2015 BY THE REGISTRAR IN TERMS OF SECTION 17 OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT 101 OF 1965) 09/21.7/11 VIRBAC RSA YPOZANE 1,875 mg OSATERONE ACETATE 1,875 mg 09/21.7/12 VIRBAC RSA YPOZANE 3,75 mg OSATERONE ACETATE 3,75 mg 09/21.7/13 VIRBAC RSA YPOZANE 7,5 mg OSATERONE ACETATE 7,5 mg 09/21.7/14 VIRBAC RSA YPOZANE 15 mg OSATERONE ACETATE 15,0 mg 10/1.4/22 CIPLA MEDPRO DOMIVET MEDETOMIDINE HYDROCHLORIDE 1,0 mg 11/17.1/09 NORBROOK LABORATORIES SA (PTY) CYFLOR INJECTION FOR CATTLE AND SWINE 31/15.4/0458 SOFLENS MINIMS PHENYLEPHRINE 2,5 % LORFENICOL 300,0 mg Each 0,5 ml SOLUTION PHENYLEPHRINE HYDROCHLORIDE 12,5 mg A39/20.1.2/0068 UNICHEM SA MYCLAV 375 AMOXICILLIN 250,0 mg 12.86_Notification_of Jun15_v1 Feb 2016 Page 1 of 6

Notification of of Medicines A39/20.1.2/0069 UNICHEM SA MYCLAV 625 AMOXICILLIN 500,0 mg 41/28/0429 MEDICINE DEVELOPERS INTERNATIONAL cc 41/28/0430 MEDICINE DEVELOPERS INTERNATIONAL cc 42/20.1.2/0307 GROUP LABORATORIES SOUTH AFRICA 42/20.1.2/0308 GROUP LABORATORIES SOUTH AFRICA 42/20.1/0774 ADCOCK INGRAM LIMITED 42/20.1/0775 ADCOCK INGRAM LIMITED 42/20.1/0776 ADCOCK INGRAM LIMITED SCANLUX 300 mg/ml SCANLUX 370 mg/ml CLAVAM ES GSK AMOXICILLIN/ CLAVULANATE ES AMOXYCLAV RESTAN BD AMOXYCLAV RESTAN 375 AMOXYCLAV RESTAN 625 IOPAMIDOL IODINE 300,0 mg IOPAMIDOL IODINE 370,0 mg Each 5,0 ml SUSPENSION AMOXICILLIN 600,0 mg CLAVULANIC ACID 42,9 mg Each 5,0 ml SUSPENSION AMOXICILLIN 600,0 mg CLAVULANIC ACID 42,9 mg AMOXYCILLIN TRIHYDRATE AMOXYCILLIN 875,0 mg AMOXYCILLIN TRIHYDRATE AMOXYCILLIN 250,0 mg AMOXYCILLIN TRIHYDRATE AMOXYCILLIN 500,0 mg 12.86_Notification_of Jun15_v1 Feb 2016 Page 2 of 6

Notification of of Medicines 43/3.2/0343 AKACIA HEALTHCARE DRONEX 35 43/2.6.5/0666 ZYDUS HEALTHCARE SA ZOLANZ 5 TABLETS 43/2.6.5/0667 ZYDUS HEALTHCARE SA ZOLANZ 10 TABLETS 43/2.10/0722 PHARMACARE LIMITED ASPEN BACLOFEN 10 mg 43/2.10/0723 PHARMACARE LIMITED ASPEN BACLOFEN 25 mg 43/20.2.8/0766 SPECPHARM SPEC VALACYCLOVIR 500 43/5.10/0892 B. BRAUN MEDICAL (PTY) 43/5.10/0893 B. BRAUN MEDICAL (PTY) 44/20.2.8/0128 ABBOTT LABORATORIES SA ONDANSETRON B BRAUN 4 mg INJECTION ONDANSETRON B BRAUN 8 mg INJECTION NORVIR 100 mg TABLETS RISEDRONATE SODIUM HEMIPENTAHYDRATE RISEDRONATE SODIUM 35,0 mg OLANZAPINE 5,0 mg OLANZAPINE 10,0 mg BACLOFEN 10,0 mg BACLOFEN 25,0 mg VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR 500,0 mg Each AMPOULE ONDANSETRON HYDROCHLORIDE ONDANSETRON 4,0 mg Each AMPOULE ONDANSETRON HYDROCHLORIDE ONDANSETRON 8,0 mg RITONAVIR 100,0 mg 44/3.2/0350 MSD FOSAVANCE 5 600 ALENDROANTE SODIUM ALENDRONIC ACID 70,0 mg CHOLECALCIFEROL equivalent to VITAMIN D 3 2 800,0 I.U. 44/34/0432 MSD BRIDION SOLUTION FOR INJECTION 100 mg/ml 44/2.6.5/0854 WINTHROP 44/2.6.5/0855 WINTHROP 44/2.6.5/1019 WINTHROP 44/2.6.5/1020 WINTHROP OLAWIN ORODISPERSIBLE 5 mg OLAWIN ORODISPERSIBLE 10 mg OLAWIN FILM-COATED 2,5 mg OLAWIN FILM-COATED 5 mg SUGAMMADEX 100,0 mg OLANZAPINE 5,0 mg OLANZAPINE 10,0 mg OLANZAPINE 2,5 mg OLANZAPINE 5,0 mg 12.86_Notification_of Jun15_v1 Feb 2016 Page 3 of 6

Notification of of Medicines 44/2.6.5/1021 WINTHROP OLAWIN FILM-COATED 10 mg OLANZAPINE 10,0 mg 44/15.4/1052 PHARMACARE LIMITED GLAUOPT CO DORZOLOMIDE HYDROCHLORIDE DORZOLOMIDE 2,0 mg TIMOLOL MALEATE equivalent to TIMOLOL 5,0 mg 45/5.7.1/0004 LASARA TRADERS (PTY) 45/20.1.1/0026 PHARMASCRIPT 45/20.2.2/0543 PHARMA DYNAMICS 45/20.1.1/0684 MACLEODS SA 45/20.1.1/0685 MACLEODS SA DEHRIN SOLUTION KLARYNOXA 500 ZUCAN 2 mg/ml MACLEODS LEVOFLOXACIN TABLETS 250 MACLEODS LEVOFLOXACIN TABLETS 500 Each 5,0 ml SOLUTION DESLORATADINE 2,5 mg CLARITHROMYCIN 500,0 mg FLUCONAZOLE 2,0 mg LEVOFLOXACIN 250,0 mg LEVOFLOXACIN 500,0 mg 45/15.4/0686 PHARMACARE LIMITED PANAMOR EYE DROPS DICLOFENAC SODIUM 1,0 mg 45/7.1.3/0706 NOVARTIS SOUTH AFRICA 45/7.1.3/0707 NOVARTIS SOUTH AFRICA DAFIRO 5/160 mg DAFIRO 10/160 mg AMLODIPINE 5,0 mg AMLODIPINE 10,0 mg 45/7.1.5/0788 CIPLA MEDPRO ZENEGRA 50 SILDENAFIL 50,0 mg 45/2.5/0820 PHARMADYNE HEALTHCARE 45/2.5/0821 PHARMADYNE HEALTHCARE 45/2.5/0822 PHARMADYNE HEALTHCARE 45/2.5/0823 PHARMADYNE HEALTHCARE CLONAM 0,5 CLONAM 2 CLONAZEPAM PHARMADYNE 0,5 CLONAZEPAM PHARMADYNE 2 CLONAZEPAM 0,5 mg CLONAZEPAM 2,0 mg CLONAZEPAM 0,5 mg CLONAZEPAM 2,0 mg 12.86_Notification_of Jun15_v1 Feb 2016 Page 4 of 6

Notification of of Medicines 45/7.1.3/0850 NOVARTIS SOUTH AFRICA 45/7.1.3/0851 NOVARTIS SOUTH AFRICA 45/7.1.3/0974 PHARMA DYNAMICS 45/7.1.3/0975 PHARMA DYNAMICS 45/7.1.3/0976 PHARMA DYNAMICS 45/7.1.3/0977 PHARMA DYNAMICS 45/7.1.3/0978 PHARMA DYNAMICS 45/7.1.3/0979 PHARMA DYNAMICS 45/18.2/1028 ZYDUS HEALTHCARE SA 45/18.2/1062 ZYDUS HEALTHCARE SA COPALIA 5/160 mg COPALIA 10/160 mg DYNA TELMISARTAN 20 mg DYNA TELMISARTAN 40 mg DYNA TELMISARTAN 80 mg TESAR 20 mg TESAR 40 mg TESAR 80 mg DESMOPRESSIN ZYDUS 10 ug/0,1 ml DESPRESS NASAL SPRAY AMLODIPINE 5,0 mg AMLODIPINE 10,0 mg TELMISARTAN 20,0 mg TELMISARTAN 40,0 mg TELMISARTAN 80,0 mg TELMISARTAN 20,0 mg TELMISARTAN 40,0 mg TELMISARTAN 80,0 mg DESMOPRESSIN ACETATE 0,1 mg DESMOPRESSIN ACETATE 0,1 mg 46/7.1.5/0100 PHARMAPLAN SILDENAFIL LITHA 25 SILDENAFIL 25,0 mg 46/7.1.5/0101 PHARMAPLAN SILDENAFIL LITHA 50 SILDENAFIL 50,0 mg 46/7.1.5/0102 PHARMAPLAN SILDENAFIL LITHA 100 SILDENAFIL 100,0 mg 46/13.11/0163 PHARMAPLAN DAPTA GEL Each 1,0 g GEL ADAPALENE 1,0 mg 46/7.1.3/0184 BRIMPHARM SA (PTY) 46/7.1.3/0185 BRIMPHARM SA (PTY) CANDETRAN 8 CANDETRAN 16 8,0 mg 16,0 mg 12.86_Notification_of Jun15_v1 Feb 2016 Page 5 of 6

Notification of of Medicines 46/7.1.3/0186 BRIMPHARM SA (PTY) 46/7.1.3/0231 LASARA TRADERS (PTY) 46/7.1.3/0232 LASARA TRADERS (PTY) 46/7.1.3/0233 LASARA TRADERS (PTY) 47/7.1.3/0282 NOVARTIS SOUTH AFRICA 47/7.1.3/0283 NOVARTIS SOUTH AFRICA 47/18.8/0525 ACTOR PHARMA (PTY) 48/20.2.8/0347 NOVAGEN PHARMA (PTY) 48/20.2.8/0348 NOVAGEN PHARMA (PTY) 48/30.1/1063 SANOFI-AVENTIS SOUTH AFRICA CANDETRAN 32 ABECARD 8 ABECARD 16 ABECARD 32 IMPRIDA 5/160 mg IMPRIDA 10/160 mg LEVETTE ARION ANCHOA BIVALENT ORAL POLIO MERIEUX 32,0 mg 8,0 mg 16,0 mg 32,0 mg AMLODIPINE 5,0 mg AMLODIPINE 10,0 mg LEVONORGESTREL 0,15 mg ETHINYLESTRADIOL 0,03 mg EFAVIRENZ 600,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg EFAVIRENZ 600,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg Each 0,1 ml SUSPENSION TYPE 1 POLIO VIRUS (LS-c2ab strain) at least 10 (6.0) CCID 50 TYPE 3 POLIO VIRUS (LEON 12a1 b strain) at lteast 10 (5.8) CCID DR JC GOUWS REGISTRAR OF MEDICINES 12.86_Notification_of Jun15_v1 Feb 2016 Page 6 of 6