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) 08/3.1.2/14 INGELHEIM A39/34/0605 A39/34/0606 A39/34/0607 A39/34/0608 AFRICA AFRICA AFRICA AFRICA 41/11.10/0215 RECKITT BENCKISER METACAM 20 mg/ml FOR CATTLE, PIGS AND HORSES NICOTINELL FRUIT 2 mg COATED CHEWING GUM NICOTINELL FRUIT 4 mg COATED CHEWING GUM NICOTINELL MINT 2 mg COATED CHEWING GUM NICOTINELL MINT 4 mg COATED CHEWING GUM GAVISCON LIQUISHOT 41/21.10/0523 SERONO SA OVITRELLE 250 µg/0,5 ml 42/26/0608 PHARMACARE LIMITED ASPEN CARBOPLATIN 50 mg 42/26/0609 PHARMACARE LIMITED ASPEN CARBOPLATIN 150 mg 42/26/0610 PHARMACARE LIMITED ASPEN CARBOPLATIN 450 mg 42/20.1.1/0247 PHARMACARE LIMITED ASPEN AZITHROMYCIN IV Each 1,0 ml solution contains: MELOXICAM 20,0 mg NICOTINE 2,0 mg NICOTINE 4,0 mg NICOTINE 2,0 mg NICOTINE 4,0 mg Each sachet contains: SODIUM ALGINATE 500,0 mg Each 0,5 ml solution contains: CHORIOGONADOTROPIN ALFA 250,0 µg Each 5,0 ml vial contains: CARBOPLATIN 50,0 mg Each 15,0 ml vial contains: CARBOPLATIN 150,0 mg Each 45,0 ml vial contains: CARBOPLATIN 450,0 mg AZITHROMYCIN MONOHYDRATE AZITHROMYCIN 500,0 mg 12.64_Notification_of Apr12_v1.docx June 2012 Page 1 of 5
42/21.5.1/0310 XIXIA 42/21.5.1/0311 XIXIA 42/21.5.1/0312 XIXIA PREDNISOLONE 120 PREDNISOLONE 500 PREDNISOLONE 1 000 HEMISUCCINATE 120,0 mg HEMISUCCINATE 500,0 mg HEMISUCCINATE 1 000,0 mg 42/7.1.3/0352 PHARMACARE LIMITED TRANDOPRESS 0,5 mg Each capsule contains: TRANDOLAPRIL 0,5 mg 42/20.1.1/0641 GULF DRUG COMPANY GULF CEFOTAXIME 2 g CEFOTAXIME SODIUM CEFOTAXIME 2,0 g 42/7.5/0805 PHARMACARE LIMITED VATICOL XL FLUVASTATIN SODIUM FLUVASTATIN 80,0 mg 42/7.1.3/0947 RANBAXY SA IRBELO 75 IRBESARTAN 75,0 mg 42/7.1.3/0948 RANBAXY SA IRBELO 150 IRBESARTAN 150,0 mg 42/7.1.3/0949 RANBAXY SA IRBELO 300 IRBESARTAN 300,0 mg 42/7.1.3/0950 RANBAXY SA RAN IRBESARTAN 75 IRBESARTAN 75,0 mg 42/7.1.3/0951 RANBAXY SA RAN IRBESARTAN 150 IRBESARTAN 150,0 mg 42/7.1.3/0952 RANBAXY SA RAN IRBESARTAN 300 IRBESARTAN 300,0 mg 42/26/0965 XIXIA 42/26/0966 XIXIA MYLAN CARBOPLATIN 150 MYLAN CARBOPLATIN 450 CARBOPLATIN 150,0 mg CARBOPLATIN 450,0 mg 42/2.9/0967 PHARMACARE LIMITED TRAMASPEN 50 mg Each capsule contains: 42/21.12/1096 ASTRAZENECA 43/2.6.5/0039 TRINITY PHARMA (PTY) 43/2.6.5/0040 TRINITY PHARMA (PTY) EVERDEX 1 mg RISPEVON 1 RISPEVON 2 TRAMADOL HYDROCHLORIDE 50,0 mg ANASTROZOLE 1,0 mg RISPERIDONE 1,0 mg RISPERIDONE 2,0 mg 12.64_Notification_of Apr12_v1.docx June 2012 Page 2 of 5
43/2.6.5/0041 TRINITY PHARMA (PTY) 43/2.6.5/0042 TRINITY PHARMA (PTY) 43/26/0046 XIXIA 43/20.1.1/0062 ORCHID SA 43/20.1.1/0063 ORCHID SA 43/26/0068 XIXIA 43/20.1.1/0221 BRIMPHARM SA (PTY) RISPEVON 3 RISPEVON 4 MYLAN GEMCITABINE 1 g ORCHID CEFUROXIME 250 mg ORCHID CEFUROXIME 500 mg MYLAN GEMCITABINE 200 mg ZEEMIDE 500 mg 43/11.4.3/0545 PHARMACARE LIMITED ASPEN PANTOPRAZOLE 20 43/11.4.3/0546 PHARMACARE LIMITED ASPEN PANTOPRAZOLE 40 43/20.2.8/0570 AUROBINDO PHARMA 43/20.2.8/0571 AUROBINDO PHARMA 43/2.5/0823 TRINITY PHARMA (PTY) 43/2.5/0824 TRINITY PHARMA (PTY) 43/2.5/0825 TRINITY PHARMA (PTY) 43/2.5/0826 TRINITY PHARMA (PTY) VUDERIT 30 mg VUDERIT 40 mg EPIMATE 25 EPIMATE 50 EPIMATE 100 EPIMATE 200 RISPERIDONE 3,0 mg RISPERIDONE 4,0 mg GEMCITABINE GEMCITABINE 1,0 g CEFUROXIME AXETIL CEFUROXIME 250,0 mg CEFUROXIME AXETIL CEFUROXIME 500,0 mg GEMCITABINE GEMCITABINE 200,0 mg AZITHROMYCIN DIHYDRATE AZITHROMYCIN 500,0 mg SESQUIHYDRATE PANTOPRAZOLE 20,0 mg SESQUIHYDRATE PANTOPRAZOLE 40,0 mg STAVUDINE 30,0 mg STAVUDINE 40,0 mg TOPIRAMATE 25,0 mg TOPIRAMATE 50,0 mg TOPIRAMATE 100,0 mg TOPIRAMATE 200,0 mg 43/11.4.3/1001 NYCOMED PANTOLOC OTC SESQUIHYDRATE PANTOPRAZOLE 20,0 mg 43/1.2/1015 ZYDUS HEALTHCARE SA ZYDUS ESCITALOPRAM 10 mg ESCITALOPRAM OXALATE EQUIVALENT TO ESCITALOPRAM 10,0 mg 12.64_Notification_of Apr12_v1.docx June 2012 Page 3 of 5
43/7.1.3/1044 AUROBINDO PHARMA 43/7.1.3/1045 AUROBINDO PHARMA 43/7.1.3/1046 AUROBINDO PHARMA 43/7.1.3/1047 AUROBINDO PHARMA 44/20.1.1/0316 BIOTECH LABORATORIES (PTY) 44/34/0391 CIPLA MEDPRO (PTY) 44/34/0392 CIPLA MEDPRO (PTY) 44/8.1/0550 NOVO NORDISK (PTY) 44/8.1/0551 NOVO NORDISK (PTY) 44/8.1/0552 NOVO NORDISK (PTY) 44/13.9.1/0632 ADCOCK INGRAM LIMITED BIQURETIC 10/ BIQURETIC 20/ AURO QUINAPRIL CO 10/ AURO QUINAPRIL CO 20/ KANAMYCIN 1 g BIOTECH SOLVENT FOR DOCELEX 20 SOLVENT FOR DOCELEX 80 NOVOSEVEN 1 mg NOVOSEVEN 2 mg NOVOSEVEN 5 mg XAMIOL GEL QUINAPRIL 10,0 mg QUINAPRIL 20,0 mg QUINAPRIL 10,0 mg QUINAPRIL 20,0 mg Each ampoule contains: KANAMYCIN SULPHATE KANAMYCIN 1 000,0 mg ETHANOL 13,0 % m/v ETHANOL 13,0 % m/v (rfviia) 1,0 mg (rfviia) 2,0 mg (rfviia) 5,0 mg Each gram contains: CALCIPOTRIOL HYDRATE CALCIPOTRIOL 50,0 µg BETAMETHASONE DIPROPIONATE BETAMETHASONE 0,5 mg 45/20.2.8/0111 MYLAN RILOVIA 200/50 LOPINAVIR 200,0 mg RITONAVIR 50,0 mg 12.64_Notification_of Apr12_v1.docx June 2012 Page 4 of 5
45/20.2.8/0112 MYLAN TENEMINE TENOFOVIR DISOPROXIL FUMARATE 300,0 mg EMTRICITABINE 200,0 mg 45/20.2.8/0169 MYLAN EFRIN EFAVIRENZ 600,0 mg 45/20.2.8/0336 MYLAN RILOVIA 100/25 LOPINAVIR 100,0 mg RITONAVIR 25,0 mg 45/20.2.8/0538 MACLEODS SA MACLEODS LAMIVUDINE 150 MS MANDISA HELA REGISTRAR OF MEDICINES 12.64_Notification_of Apr12_v1.docx June 2012 Page 5 of 5