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) 36/20.1.2/0204 BIOTECH 36/20.1.2/0205 BIOTECH ADIPEN 375 (TABLETS) ADIPEN 625 (TABLETS) AMOXICILLIN TRIHYDRATE AMOXICILLIN 250,0 mg POTASSIUM CLAVULANATE CLAVULANIC ACID 125,0 mg AMOXICILLIN TRIHYDRATE AMOXICILLIN 500,0 mg POTASSIUM CLAVULANATE CLAVULANIC ACID 125,0 mg A40/5.4/0439 PHARMAFRICA DETRUNORM XL PROPIVERINE HYDROCHLORIDE 30,0 mg 42/20.2.2/0085 PHARMAPLAN ALMATIL 125 mg (tablets) 42/20.2.2/0086 PHARMAPLAN ALMATIL 250 mg (tablets) to 125,0 mg to 250,0 mg 42/5.3/0293 NOVARTIS SA EXELON PATCH 5 Each 5,0 cm 2 patch contains: RIVASTIGMINE 9,0 mg 42/5.3/0294 NOVARTIS SA EXELON PATCH 10 Each 10,0 cm 2 patch contains: RIVASTIGMINE 18,0 mg 42/20.2.2/0382 PHARMAPLAN ALMATIL 1 % CREAM Each 1,0 g cream contains: to 10,0 mg 12.75_Notification_of Oct13_v1 November 2013 Page 1 of 5
2 42/7.1.3/0392 TRINITY PHARMA (PTY) NEBICARD-5 42/20.2.2/0685 SPECPHARM SPEC FLUCONAZOLE /20.1.1/0012 ORCHID SA 43/1.2/0097 XIXIA 43/1.2/0098 XIXIA 43/5.4.1/0119 PHARMA SOUTH AFRICA 43/5.4.1/0120 PHARMA SOUTH AFRICA 43/5.4.1/0121 PHARMA SOUTH AFRICA 43/5.4.1/0122 PHARMA SOUTH AFRICA 43/5.4.1/0123 PHARMA SOUTH AFRICA 43/5.4.1/0124 PHARMA SOUTH AFRICA 43/5.4.1/0125 PHARMA SOUTH AFRICA 43/5.4.1/0126 PHARMA SOUTH AFRICA 43/15.4/0136 GULF DRUG COMPANY ORCHID CEFPODOXIME 100 mg MYLAN VENLAFAZINE 75 MYLAN VENLAFAZINE 150 0,5 0,25 1 1,5 AROXOLE 0,5 AROXOLE 0,25 AROXOLE 1 AROXOLE 1,5 OCCUMOL 0,5 % (eye drop) NEBIVOLOL to NEBIVOLOL 5,0 mg CEFPODOXIME PROXETIL CEFPODOXIME 100,0 mg VENLAFAXINE to VENLAFAXINE 75,0 mg VENLAFAXINE to VENLAFAXINE 150,0 mg MONOHYDRATE 0,5 mg MONOHYDRATE 0,25 mg MONOHYDRATE 1,0 mg MONOHYDRATE 1,5 mg MONOHYDRATE 0,5 mg MONOHYDRATE 0,25 mg MONOHYDRATE 1,0 mg MONOHYDRATE 1,5 mg TIMOLOL MALEATE equivalent to TIMOLOL 5,0 mg 12.75_Notification_of Oct13_v1 November 2013 Page 2 of 5
3 43/15.4/0137 GULF DRUG COMPANY 43/20.1.1/0391 ADCOCK INGRAM CRITICAL CARE (PTY) 43/20.2.2/0560 AUROBINDO PHARMA 43/20.2.2/0561 AUROBINDO PHARMA 43/20.2.2/0562 AUROBINDO PHARMA 43/20.2.2/0563 AUROBINDO PHARMA 43/20.2.2/0566 AUROBINDO PHARMA 43/20.2.2/0567 AUROBINDO PHARMA 43/20.2.2/0568 AUROBINDO PHARMA 43/20.2.2/0569 AUROBINDO PHARMA 43/20.1.1/0573 PHARMA DYNAMICS 43/34/0574 PHARMA DYNAMICS 43/20.1.1/0575 PHARMA DYNAMICS OCCUMOL 0,25 % (eye drop) PIPERACILLIN AND TAZOBACTAM 4 g/0,5 g PROPAN 50 mg 100 mg 150 mg 200 mg INSEP 50 INSEP 100 INSEP 150 INSEP mg IV SOLVENT 400 mg IV 43/3.2/0636 PHARMAPLAN OSTEONEL ONCE A WEEK TIMOLOL MALEATE equivalent to TIMOLOL 2,5 mg PIPERACILLIN MONOHYDRATE PIPERACILLIN 4,0 g TAZOBACTAM 0,5 g FLUCONAZOLE 50,0 mg FLUCONAZOLE 100,0 mg FLUCONAZOLE 200,0 mg FLUCONAZOLE 50,0 mg FLUCONAZOLE 100,0 mg FLUCONAZOLE 200,0 mg TEICOPLANIN 200,0 mg Each ampoule contains: WATER FOR INJECTION 3,2 ml TEICOPLANIN 400,0 mg RISEDRONATE SODIUM HEMIPENTAHYDRATE : RISEDRONATE SODIUM 35,0 mg 43/8.2/0753 MC PHARMA CPD SOLUTION Each 1 000,0 ml contains: MONOBASIC SODIUM PHOSPHATE 1,93 g CITRIC ACID 2,99 g DEXTROSE 23,3 g SODIUM CITRATE 23,06 g 43/20.1.1/0947 SANOFI-AVENTIS SOUTH AFRICA 43/20.1.1/1058 WINTHROP TAVANIC 750 LEVOFLOXACIN WINTHROP 750 LEVOFLOXACIN 750,0 mg LEVOFLOXACIN 750,0 mg 44/30.2/0097 NOVARTIS SA ILARIS 150 mg/ml CANAKINUMAB 150,0 mg 44/21.12/0154 AKACIA HEALTHCARE ROZARA LETROZOLE 2,5 mg 12.75_Notification_of Oct13_v1 November 2013 Page 3 of 5
4 44/2.5/0402 LASARA TRADERS (PTY) 44/2.5/0403 LASARA TRADERS (PTY) 44/2.5/0404 LASARA TRADERS (PTY) 44/5.4.1/0456 SOLVAY PHARMA (PTY) NUREP 100 NUREP 300 NUREP 400 DUODOPA 44/7.1.3/0554 SANDOZ SA SANDOZ CANDESARTAN PLUS 44/7.1.3/0555 SANDOZ SA CANDEPRES PLUS GABAPENTIN 100,0 mg GABAPENTIN 300,0 mg GABAPENTIN 400,0 mg LEVODOPA 20,0 mg CARBIDOPA MONOHYDRATE 5,0 mg 44/8.2/0782 MC PHARMA SAG-M SOLUTION Each 1 000,0 ml contains: ADENINE 169,0 mg MANNITOL 5,25 g SODIUM CHLORIDE 8,77 g DEXTROSE MONOHYDRATE 9,0 g WATER FOR INJECTION 985,0 g 44/10.2.2/0826 PHARMA DYNAMICS 44/10.2.2/0827 PHARMA DYNAMICS 44/10.2.2/0828 PHARMA DYNAMICS MONTEIL 4 mg MONTEIL 5 mg MONTEIL 10 mg MONTELUKAST 4,0 mg MONTELUKAST 5,0 mg MONTELUKAST 10,0 mg 44/21.8.2/0957 BAYER ELOINE Each pack of tablets contain: 24 tablets each containing: DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,02 mg plus 4 PLACEBO tablets 45/32.2/0118 PHARMAPLAN SILODYX 4 SILODOSIN 4,0 mg 45/32.2/0119 PHARMAPLAN SILODYX 8 SILODOSIN 8,0 mg 45/20.2.8/0388 MYLAN MIVIRDO LAMIVUDINE 150,0 mg NEVIRAPINE 200,0 mg ZIDOVUDINE 300,0 mg 12.75_Notification_of Oct13_v1 November 2013 Page 4 of 5
5 45/7.1.3/0394 MYLAN MYLACAND PLUS 45/34/0513 DR REDDY S BLAZTERE 5 mg/100 ml Each 5,0 ml vial contains: ZOLEDRONIC ACID MONOHYDRATE ZOLEDRONIC ACID 4,0 mg 45/18.8/0535 BAYER YASMIN PLUS Each every-day pack contains: 21 orange tablets containing: DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,03 mg LEVOMEFOLATE CALCIUM 0,451 mg 7 light orange tablets containing: LEVOMEFOLATE CALCIUM 0,451 mg 45/21.12/0544 EQUITY 45/7.1.3/0610 RANBAXY (S.A.) (PTY) 45/7.1.3/0611 RANBAXY (S.A.) (PTY) 45/1.2/0881 MACLEODS SA 45/1.2/0882 MACLEODS SA 45/21.12/0908 EQUITY 45/26/1127 ASTELLAS PHARMA 45/26/1128 ASTELLAS PHARMA 46/26/0870 ROCHE PRODUCTS (PTY) 46/26/0871 ROCHE PRODUCTS (PTY) MS M HELA REGISTRAR OF MEDICINES LETRAZ TELGEN 40 TELGEN 80 MACLEODS ESCITALOPRAM 10 mg MACLEODS ESCITALOPRAM 20 mg EQUISIN RIBOMUSTIN 25 mg RIBOMUSTIN 100 mg XUBIX 150 XUBIX 500 LETROZOLE 2,5 mg TELMISARTAN 40,0 mg TELMISARTAN 80,0 mg ESCITALOPRAM OXALATE ESCITALOPRAM 10,0 mg ESCITALOPRAM OXALATE ESCITALOPRAM 20,0 mg EXEMESTANE 25,0 mg BENDAMUSTINE HYDROCHLORIDE 25,0 mg BENDAMUSTINE HYDROCHLORIDE 100,0 mg CAPECITABINE 150,0 mg CAPECITABINE 500,0 mg 12.75_Notification_of Oct13_v1 November 2013 Page 5 of 5
MEDICINES CONTROL COUNCIL
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) 47/26/0920 SANOFI-AVENTIS
MEDICINES CONTROL COUNCIL
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) 42/2.5/0453 ZYDUS HEALTHCARE
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MEDICINES CONTROL COUNCIL
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) 41/20.1.1/0039 SCP MYLAN
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MEDICINES CONTROL COUNCIL
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