MEDICINES CONTROL COUNCIL
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- Derrick Stafford
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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) 06/17.1.6/07 AFRIVET LOGISTICS 08/ /03 CIPLA MEDPRO (PTY) 09/ /19 CEVA ANIMAL HEALTH 10/5.3.2/11 ACCORD HEALTHCARE 10/5.3.2/12 ACCORD HEALTHCARE 10/5.3.2/13 ACCORD HEALTHCARE 10/5.3.2/14 ACCORD HEALTHCARE 37/21.5.1/0013 BIOTECH 37/21.5.1/0014 BIOTECH 37/21.5.1/0015 BIOTECH MARBOCYL 10 % PETCAM INJECTION 0,5 % CANIFLAM BREXACE 5 PETACE 20 BREXACE 20 PETACE 20 PULMAX 100 MDI PULMAX 200 MDI PULMAX 400 MDI MARBOFLOXACIN 100,0 mg MELOXICAM MELOXICAM 1,5 mg BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 20,0 mg BENAZEPRIL HYDROCHLORIDE 20,0 mg BENAZEPRIL HYDROCHLORIDE Each actuation contains: BUDESONIDE 100,0 µg Each actuation contains: BUDESONIDE 200,0 µg Each actuation contains: BUDESONIDE 400,0 µg 41/11.4.3/0449 BAYER RENNIE DUO Each 10,0 ml contains: CALCIUM CARBONATE 1 200,0 mg MAGNESIUM CARBONATE 140,0 mg SODIUM ALGINATE 300,0 mg 12.76_Notification_of Dec13_v1 April 2014 Page 1 of 10
2 41/5.7.1/0555 GULF DRUG COMPANY 41/20.1.1/586 AUROBINDO PHARMA 41/20.1.1/587 AUROBINDO PHARMA GULF CETIRIZINE 10 LIZORP 250 mg LIZORP 500 mg 42/3.2/0410 LITHA PHARMA ASTERIX ALENDRONATE 70 42/2.7/0543 CIPLA MEDPRO (PTY) PARAFIZZ 500 CETIRIZINE DIHYDROCHLORIDE CEPROZIL MONOHYDRATE equivalent to ANHYDROUS CEFPROZIL 250,0 mg CEPROZIL MONOHYDRATE equivalent to ANHYDROUS CEFPROZIL 500,0 mg ALENDRONATE SODIUM TRIHYDRATE equivalent to ALENDRONIC ACID 70,0 mg PARACETAMOL 500,0 mg 42/26/0742 PHARMAPLAN CANOTEC IRINOTECAN HYDROCHLORIDE TRIHYDRATE 20,0 mg 42/3.2/0767 PHARMA DYNAMICS 42/3.2/0768 PHARMA DYNAMICS 42/20.1.1/0998 PHARMA DYNAMICS 43/5.3/0099 PFIZER LABORATORIES 43/5.3/0100 PFIZER LABORATORIES 43/1.2/0339 LEBASI cc 43/1.2/0340 LEBASI cc 43/26/0467 SAFELINE DYNA RISEDRONATE 5 mg DYNA RISEDRONATE 35 mg LEVONIC IV 500 ARICEPT ODT 5 mg ARICEPT ODT 10 mg DYNA SERTRALINE 50 DYNA SERTRALINE 100 PLIXEL RISEDRONATE SODIUM HEMIPENTAHYDRATE equivalent to RISEDRONATE SODIUM RISEDRONATE SODIUM HEMIPENTAHYDRATE equivalent to RISEDRONATE SODIUM 3 Each 100,0 ml solution contains: LEVOFLOXACIN 500,0 mg HYDROCHLORIDE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE equivalent to SERTRALINE 50,0 mg SERTRALINE HYDROCHLORIDE equivalent to SERTRALINE 100,0 mg PACLITAXEL 30,0 mg 43/5.3/0668 PHARMAPLAN ARIMER 5 mg HYDROCHLORIDE 12.76_Notification_of Dec13_v1 April 2014 Page 2 of 10
3 43/5.3/0669 PHARMAPLAN ARIMER 10mg HYDROCHLORIDE 43/7.5/0837 PHARMACIA SOUTH AFRICA 43/7.5/0839 PHARMACIA SOUTH AFRICA ASPAVOR 80 ATORVASTATIN PHARMACIA 80 ATORVASTATIN CALCIUM TRIHYDRATE equivalent to ATORVASTATIN 80,0 mg ATORVASTATIN CALCIUM TRIHYDRATE equivalent to ATORVASTATIN 80,0 mg 43/7.1.3/0925 BIOGARAN SA FLAMIPAX 5/5 43/7.1.3/0926 BIOGARAN SA FLAMIPAX 5/10 43/7.1.3/0927 BIOGARAN SA FLAMIPAX 10/5 43/7.1.3/0928 BIOGARAN SA FLAMIPAX 10/10 43/7.1.3/0929 BIOGARAN SA REAPTAN 5/5 43/7.1.3/0930 BIOGARAN SA REAPTAN 5/10 43/7.1.3/0931 BIOGARAN SA REAPTAN 10/ _Notification_of Dec13_v1 April 2014 Page 3 of 10
4 43/7.1.3/0932 BIOGARAN SA REAPTAN 10/10 43/7.1.3/0933 SERVIER LABORATORIES SA (PTY) 43/7.1.3/0934 SERVIER LABORATORIES SA (PTY) 43/7.1.3/0935 SERVIER LABORATORIES SA (PTY) 43/7.1.3/0936 SERVIER LABORATORIES SA (PTY) 43/7.1.3/0937 EGIS SA 43/7.1.3/0938 EGIS SA 43/7.1.3/0939 EGIS SA 43/7.1.3/0940 EGIS SA COVERAM 5/5 COVERAM 5/10 COVERAM 10/5 COVERAM 10/10 MIXANVAL 5/5 MIXANVAL 5/10 MIXANVAL 10/5 MIXANVAL 10/ _Notification_of Dec13_v1 April 2014 Page 4 of 10
5 43/20.1/0954 ASTRAZENECA 43/20.1.1/1025 CK INGRAM 44/8.2/0041 SANOFI-AVENTIS SOUTH AFRICA 44/8.2/0042 WINTHROP 44/8.2/0043 SANOFI-AVENTIS SOUTH AFRICA 44/2.5/0065 CK INGRAM 44/2.5/0066 CK INGRAM 44/2.5/0067 CK INGRAM 44/2.5/0068 CK INGRAM 44/2.5/0069 CK INGRAM 44/2.5/0070 CK INGRAM 44/2.5/0120 CK INGRAM 44/2.5/0121 CK INGRAM 44/2.5/0122 CK INGRAM 44/2.5/0123 CK INGRAM 44/2.5/0124 CK INGRAM 44/2.5/0125 CK INGRAM 44/2.5/0126 CK INGRAM 44/2.5/0127 CK INGRAM CUBICIN CIPROFLOXACIN 2 mg/ml CLOPIDOGREL SANOFI-AVENTIS 300 mg CLOPIWIN 300 mg PLAVIX 300 mg PROPAN 300 CR PROPAN 500 CR VANAPRO 300 VANAPRO 500 SODIUM VALPROATE 300 CR SODIUM VALPROATE 500 CR KEPRACET 250 KEPRACET 500 KEPRACET 750 KEPRACET LEVETIRACETAM 250 LEVETIRACETAM 500 LEVETIRACETAM 750 LEVETIRACETAM DAPTOMYCIN 500,0 mg Each 1 ml solution contains: CIPROFLOXACIN 2,0 mg CLOPIDOGREL HYDROGEN SULPHATE equivalent to CLOPIDOGREL 300,0 mg CLOPIDOGREL HYDROGEN SULPHATE equivalent to CLOPIDOGREL 300,0 mg CLOPIDOGREL HYDROGEN SULPHATE equivalent to CLOPIDOGREL 300,0 mg 300,0 mg 500,0 mg 300,0 mg 500,0 mg 300,0 mg 500,0 mg LEVETIRACETAM 250,0 mg LEVETIRACETAM 500,0 mg LEVETIRACETAM 750,0 mg LEVETIRACETAM 1 000,0 mg LEVETIRACETAM 250,0 mg LEVETIRACETAM 500,0 mg LEVETIRACETAM 750,0 mg LEVETIRACETAM 1 000,0 mg 12.76_Notification_of Dec13_v1 April 2014 Page 5 of 10
6 44/11.4.3/0208 ASTRAZENECA 44/11.4.3/0209 ASTRAZENECA NEXIUM 2,5 mg SACHETS NEXIUM 5 mg SACHETS 44/3.2/0258 SANDOS SA SANDOZ IBANDRONATE 2 mg/2 ml 44/3.2/0259 SANDOS SA SANDOZ IBANDRONATE 6 mg/6 ml Each sachet contains: ESOMEPRAZOLE MAGNESIUM TRIHYDRATE equivalent to ESOMEPRAZOLE 2,5 mg Each sachet contains: ESOMEPRAZOLE MAGNESIUM TRIHYDRATE equivalent to ESOMEPRAZOLE Each ampoule contains: IBANDRONATE SODIUM MOHOHYDRATE equivalent to IBANDRONIC ACID 2,0 mg Each ampoule contains: IBANDRONATE SODIUM MOHOHYDRATE equivalent to IBANDRONIC ACID 6,0 mg 44/7.1.3/0265 RANBAXY (SA) CANDESARTAN RAN 8 CANDESARTAN CILEXETIL 8,0 mg 44/7.1.3/0266 RANBAXY (SA) CANDESARTAN RAN 16 CANDESARTAN CILEXETIL 16,0 mg 44/7.1.3/0267 RANBAXY (SA) CANDAGEN 8 CANDESARTAN CILEXETIL 8,0 mg 44/7.1.3/0268 RANBAXY (SA) CANDAGEN 16 CANDESARTAN CILEXETIL 16,0 mg 44/3.2/0319 SANDOZ SA BONATE 2 mg/2 ml Each ampoule contains: IBANDRONATE SODIUM MONOHYDRATE equivalent to IBANDRONIC ACID 2,0 mg 44/3.2/0320 SANDOZ SA BONATE 6 mg/6 ml Each ampoule contains: IBANDRONATE SODIUM MONOHYDRATE equivalent to IBANDRONIC ACID 6,0 mg 44/20.1.1/0421 TRINITY PHARMA (PTY) 44/20.1.1/0422 TRINITY PHARMA (PTY) 44/32.2/0631 ALKEM LABORATORIES LEVOFLOXACIN TRINITY 250 LEVOFLOXACIN TRINITY 500 MYCOKEM 500 LEVOFLOXACIN 250,0 mg LEVOFLOXACIN 500,0 mg MYCOPHENOLATE MOFETIL 500,0 mg 44/21.10/0763 FERRING BRAVELLE 75 I.U. UROFOLLITROPIN 75,0 I.U. 44/21.10/0764 FERRING BRAVELLE SOLVENT Each ampoule contains: SODIUM CHLORIDE (0,9 %) and 1,0 ml WATER FOR INJECTION 44/26/0886 PHARMAPLAN IMALEK 100 IMATINIB MESILATE equivalent to IMATINIB 100,0 mg 12.76_Notification_of Dec13_v1 April 2014 Page 6 of 10
7 44/26/0887 PHARMAPLAN IMALEK 400 IMATINIB MESILATE equivalent to IMATINIB 400,0 mg 44/1.2/0948 AUROBINDO PHARMA 44/1.2/0949 AUROBINDO PHARMA 44/1.2/0950 AUROBINDO PHARMA 44/1.2/0951 AUROBINDO PHARMA 44/1.2/0952 AUROBINDO PHARMA 44/1.2/0953 AUROBINDO PHARMA 44/1.2/0954 AUROBINDO PHARMA 44/1.2/0955 AUROBINDO PHARMA 44/1.2/0956 AUROBINDO PHARMA 44/11.4.3/0981 CK INGRAM 44/11.4.3/0982 CK INGRAM PRATALOPRAM 5 mg PRATALOPRAM 10 mg PRATALOPRAM 20 mg DOLIN 5 mg DOLIN 10 mg DOLIN 20 mg MARPREM 5 mg MARPREM 10 mg MARPREM 20 mg PANTOPRAZOLE IV PANTOPRAZOLE COVAN INJECTION ESCITALPRAM OXALATE 20,0 mg 20,0 mg 20,0 mg Each 15,0 ml solution contains: PANTOPRAZOLE SODIUM SESQUIHYDRATE equivalent to PANTOPRAZOLE 40,0 mg Each 15,0 ml solution contains: PANTOPRAZOLE SODIUM SESQUIHYDRATE equivalent to PANTOPRAZOLE 40,0 mg 44/21.12/1009 PHARMAPLAN ANABREZ 1 ANASTROZOLE 1,0 mg 45/15.1/0034 CK INGRAM FOXIN CIPROFLOXACIN HYDROCHLORIDE equivalent to CIPROFLOXACIN 3,0 mg 12.76_Notification_of Dec13_v1 April 2014 Page 7 of 10
8 45/26/0038 ELI LILLY (SA) LILLY PEMETREXED 100 mg 45/26/0039 ELI LILLY (SA) LILLY PEMETREXED 500 mg PEMETREXED 100,0 mg PEMETREXED 500,0 mg 45/20.1.1/0100 RANBAXY (SA) TARBACT 200 TEICOPLANIN 200,0 mg 45/20.1.1/0101 RANBAXY (SA) TARBACT 400 TEICOPLANIN 400,0 mg 45/20.1.1/0102 RANBAXY (SA) TARBACT SOLVENT Each ampoule contains: WATER FOR INJECTION 3,0 ml 45/26/0184 CIPLA MEDPRO (PTY) 45/26/0185 CIPLA MEDPRO (PTY) 45/32.2/0219 ALKEM LABORATORIES 45/32.2/0220 ALKEM LABORATORIES 45/32.2/0221 ALKEM LABORATORIES 45/8.3/0335 EQUITY BLEOCIP CIPLA BLEOMYCIN MYCOPHENOLATE ALKEM 250 mg MYCOPHENOLATE ALKEM 500 mg MYCOKEM 250 EQUIFER BLEOMYCIN SULPHATE equivalent to BLEOMYCIN 15 units BLEOMYCIN SULPHATE equivalent to BLEOMYCIN 15 units Each capsule contains: MYCOPHENOLATE MOFETIL 250,0 mg Each capsule contains: MYCOPHENOLATE MOFETIL 500,0 mg Each capsule contains: MYCOPHENOLATE MOFETIL 250,0 mg IRON (III)-HYDROXIDE SUCROSE COMPLEX equivalent to IRON 20,0 mg 45/21/12/0425 RANBAXY (SA) EXERAN EXEMESTANE 2 45/21.12/0487 ARROW PHARMA SOUTH AFRICA 45/2.7/0531 FRESENIUS KABI SOUTH AFRICA 45/20.1.1/0554 LITHA PHARMA (PTY) 45/20.1.1/0555 LITHA PHARMA (PTY) 45/20.1.1/0556 LITHA PHARMA (PTY) 45/20.2.8/0588 AUROBINDO PHARMA 45/20.2.8/0589 AUROBINDO PHARMA ANASTROZOLE WATSON PARACETAMOL FRESENIUS 10 mg/ml (50 ml) TEICOPLANIN LITHA 200 TEICOPLANIN LITHA 400 SOLVENT FOR TEICOPLANIN LITHA VALZOST 500 mg VALZOST 1 g ANASTROZOLE 1,0 mg PARACETAMOL TEICOPLANIN 200,0 mg TEICOPLANIN 400,0 mg Each ampoule contains: WATER FOR INJECTION 3,0 ml VALACICLOVIR HCl equivalent to VALACICLOVIR 500,0 mg VALACICLOVIR HCl equivalent to VALACICLOVIR 1,0 g 12.76_Notification_of Dec13_v1 April 2014 Page 8 of 10
9 45/2.5/0711 BIOTECH 45/2.5/0712 BIOTECH 45/2.5/0713 BIOTECH 45/5.3/0939 ZYDUS HEALTHCARE SA 45/5.3/0940 ZYDUS HEALTHCARE SA 45/5.3/0941 ZYDUS HEALTHCARE SA 45/5.3/0942 ZYDUS HEALTHCARE SA 45/2.7/1188 FRESENIUS KABI SOUTH AFRICA LEVETIRACETAM 250 BIOTECH LEVETIRACETAM 750 BIOTECH LEVETIRACETAM BIOTECH ALZIDO 5 mg ALZIDO 10 mg ZYDUS 5 mg ZYDUS 10 mg PARACETAMOL FRESENIUS 10 mg/ml (100 ml) LEVETIRACETAM 250,0 mg LEVETIRACETAM 750,0 mg LEVETIRACETAM 1 000,0 mg HYDROCHLORIDE HYDROCHLORIDE HYDROCHLORIDE HYDROCHLORIDE PARACETAMOL 46/8.2/0111 BAYER XARELTO 15 RIVAROXABAN 1 46/20.1.8/0793 PHARMACARE EDURANT RILPIVIRINE HYDROCHLORIDE equivalent to RILPIVIRINA 2 46/8.3/0849 ACTOR PHARMA (PTY) 47/20.2.8/0327 CK INGRAM RAUTEVENE RIZENE Each ampoule contains: IRON (III)-HYDROCHLORIDE SUCROSE COMPLEX equivalent to IRON 100,0 mg EFAVIRENZ 600,0 mg EMTRICITABINE 200,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 47/20.2.8/0740 SPECPHARM TENEMCOM EMTRICITABINE 200,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg A40/34/0520 A40/34/0523 A40/34/0565 JOHNSON & JOHNSON JOHNSON & JOHNSON JOHNSON & JOHNSON NICORETTE FRESHMINT 2 mg NICORETTE FRESHMINT 4 mg NICORETTE ICE MINT 2 mg Each piece of gum contains: NICORETTE RESINATE 20 % equivalent to NICOTINE 2,0 mg Each piece of gum contains: NICOTINE RESIN equivalent to NICOTINE 4,0 mg Each piece of gum contains: NICOTINE RESIN equivalent to NICOTINE 2,0 mg 12.76_Notification_of Dec13_v1 April 2014 Page 9 of 10
10 A40/34/0566 JOHNSON & JOHNSON NICORETTE ICE MINT 4 mg Each piece of gum contains: NICOTINE RESIN equivalent to NICOTINE 4,0 mg MS M HELA REGISTRAR OF MEDICINES 12.76_Notification_of Dec13_v1 April 2014 Page 10 of 10
MEDICINES CONTROL COUNCIL
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AVAILABLE DOSSIERS. Product name Pharmaceutical form Strength Reference Therapeutic class
DOSSIER LIST AVAILABLE DOSSIERS Product name Pharmaceutical form Strength Reference Therapeutic class ALIMENTARY TRACT & METABOLISM Esomeprazole sodium Omeprazole sodium injection / 40 mg Nexium / AstraZeneca
Product Name Strength Dosage Form Therapeutic Area Dossier Status. Aceclofenac 100mg Film coated Tablets Analgesia-inflammation Approved
Product Name Strength Dosage Form Therapeutic Area Dossier Status Aceclofenac 100mg Film coated Tablets Analgesia-inflammation Approved Alendronate Sodium 10/70mg Tablets Osteoporosis Approved Anastrozole
Table 1 Details of products supplied and the correlation coefficient of each of these products against its reference.
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While there is around a 3% increase shown in costs for Category M lines, I think this is due to the inclusion of more lines in Category M.
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