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) 36/7.5/0281 PHARMACARE LIMITED BEZACHOLE SR BEZAFIBRATE 400,0 mg 37/26/0483 KEY ONCOLOGICS (PTY) 38/7.1.3/0032 AUSTELL 38/7.1.3/0033 AUSTELL 38/26/0057 KEY ONCOLOGICS (PTY) 38/20.1.1/0204 SAFELINE PHARMACEUTICALS 38/20.1.1/0205 SAFELINE PHARMACEUTICALS A04/3.1.5/08 CEVA ANCHORPHARM ANIMAL HEALTH S.A. NEOTALEM AUSTELL-LISINOPRIL 10 mg AUSTELL-LISINOPRIL 5 mg LITAK 10 CEFUROXIME- SAFELINE 1,5 g CEFUROXIME- SAFELINE 750 mg TILDREN EACH 10,0 ml VIAL MITOXANTRONE HYDROCHLORIDE MITOXANTRONE 20,0 mg LISINOPRIL 10,0 mg LISINOPRIL 5,0 mg EACH 5,0 ml VIAL CLADRIBINE 10,0 mg EACH VIAL CEFUROXIME SODIUM CEFUROXIME 1,5 g EACH VIAL CEFUROXIME SODIUM CEFUROXIME 750,0 mg EACH VIAL TILUDRONIC ACID 50,0 mg Notification of Apr08 v1.doc June 2008 Page 1 of 9
2 A05/22.6.2/10 VIRBAC RSA ALIZINE AGLEPRISTONE 30,0 mg A38/3.2/0381 A38/2.6.5/0622 A38/2.6.5/0623 A38/2.6.5/0624 ROCHE PRODUCTS HEXAL PHARMA (S.A.) HEXAL PHARMA (S.A.) HEXAL PHARMA (S.A.) BONDRONAT 6 mg/6 ml MOXOTENS 0,2 mg MOXOTENS 0,3 mg MOXOTENS 0,4 mg EACH VIAL IBANDRONIC ACID 6,0 mg MOXONIDINE 0,2 mg MOXONIDINE 0,3 mg MOXONIDINE 0,4 mg A39/21.12/0064 MERCK CETROTIDE 0,25 EACH VIAL CETRORELIX ACETATE CETRORELIX 0,25 mg A39/21.12/0065 MERCK CETROTIDE 3 mg EACH VIAL CETRORELIX ACETATE CETRORELIX 3,0 mg A39/2.1/0077 A39/30.4/0417 A39/30.4/0418 B BRAUN MEDICAL (PTY) ADCOCK INGRAM CRITICAL CARE (PTY) ADCOCK INGRAM CRITICAL CARE (PTY) B.BRAUN PROPOFOL 1 % (10 mg/ml) CEPROTIN 500 I.U. CEPROTIN I.U. EACH 1,0 ml EMULSION PROPOFOL 10,0 mg EACH VIAL PROTEIN C 500,0 I.U. EACH VIAL PROTEIN C 1 000,0 I.U. A39/1.2/0500 PHARMAPLAN TAZERON 15 mg MIRTAZAPINE 15,0 mg A39/1.2/0501 PHARMAPLAN TAZERON 30 mg MIRTAZAPINE 30,0 mg A39/21.5.1/0584 SANDOZ S.A. SANDOZ BECLOMETHASONE DIPROPIONATE AQ 100 A40/13.4.1/0035 A40/34/0045 A40/34/0046 A40/20.1.1/0102 GALDERMA LABORATORIES S.A. CIPLA LIFE SCIENCES CIPLA MEDPRO (PTY) PFIZER LABORATORIES CLOBEX SHAMPOO CIPLA-TAMSULOSIN HYDROCHLORIDE UROMAX ZITHROMAX ONE EACH METERED NASAL SPRAY DOSE DELIVERS: BECLOMETHASONE DIPROPIONATE 100,0 μg EACH 1,0 g SHAMPOO CLOBETASOL PROPIONATE 0,5 mg EACH CAPSULE TAMSULOSIN HYDROCHLORIDE 400,0 μg EACH CAPSULE TAMSULOSIN HYDROCHLORIDE 400,0 μg EACH BOTTLE AZITHROMYCIN DIHYDRATE AZITHROMYCIN 2,0 g Notification of Apr08 v1.doc June 2008 Page 2 of 9
3 A40/21.2/0132 A40/21.2/0133 A40/21.2/0134 A40/2.5/0166 A40/2.5/0167 A40/2.5/0169 A40/2.5/0173 A40/3.1/0240 A40/7.1.3/0287 A40/7.1.3/0290 RANBAXY (SA) (PTY) RANBAXY (SA) (PTY) RANBAXY (SA) (PTY) PHARMA DYNAMICS PHARMA DYNAMICS PHARMA DYNAMICS PHARMA DYNAMICS NOVARTIS SOUTH AFRICA SANOFI-SYNTHELABO SANOFI-SYNTHELABO GLIMPID 1 GLIMPID 2 GLIMPID 4 DYNA-LAMOTRIGINE 100 mg DYNA LAMOTRIGINE 200 mg DYNA-LAMOTRIGINE 50 mg DYNA-LAMOTRIGINE 25 mg CATAFAST-D TABLETS COIRBESARTAN WINTHROP 300/12,5 COIRBESARTAN WINTHROP 150/12,5 GLIMEPIRIDE 1,0 mg GLIMEPIRIDE 2,0 mg GLIMEPIRIDE 4,0 mg LAMOTRIGINE 100,0 mg LAMOTRIGINE 200,0 mg LAMOTRIGINE 50,0 mg LAMOTRIGINE 25,0 mg DICLOFENAC SODIUM 50,0 mg IRBESARTAN 300,0 mg IRBESARTAN 150,0 mg A40/34/0299 REVISION S.A. CYCLEAN POLYHEXANIDE 0,1 μg A40/20.1.1/0309 A40/20.1.1/0310 A40/34/0314 A40/34/0315 A40/20.1.1/0522 AVENTIS PHARMA (PTY) AVENTIS PHARMA (PTY) HEXAL PHARMA (SA) HEXAL PHARMA (SA) NOVARTIS SOUTH AFRICA LEVOFLOXACIN- WINTHROP 250 LEVOFLOXACIN- WINTHROP 500 OCTREOTIDE HEXAL 0,05 mg OCTREOTIDE HEXAL 0,1 mg TOBI 300 mg/5 ml LEVOFLOXACIN HEMIHYDRATE LEVOFLOXACIN 250,0 mg LEVOFLOXACIN HEMIHYDRATE LEVOFLOXACIN 500,0 mg OCTREOTIDE 0,05 mg OCTREOTIDE 0,1 mg EACH 5,0 ml SOLUTION TOBRAMYCIN 300,0 mg Notification of Apr08 v1.doc June 2008 Page 3 of 9
4 A40/21.5.1/0524 PHARMACARE LIMITED AP METHYLPRED EACH 8,0 ml SOLUTION METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE 500,0 mg A40/20.2.8/0619 A40/20.2.8/0620 A40/3.1/0664 A40/3.1/0665 RANBAXY (S.A.) (PTY) RANBAXY (S.A.) (PTY) ARROW PHARMA ARROW PHARMA SONKE-LASTAD 30 SONKE-LASTAD 40 ARROW MELOXICAM 7,5 ARROW MELOXICAM 15 41/7.1.3/0001 PHARMACARE LIMITED ASPEN CARVEDILOL 25 mg 41/7.1.3/0002 PHARMACARE LIMITED ASPEN CARVEDILOL 6,25 mg 41/7.1.3/0003 PHARMACARE LIMITED ASPEN CARVEDILOL 41/30.1/0025 AVENTIS PHARMA (PTY) 41/20.2.3/0079 DEZZO TRADING (392) t/a INDO PHARMA 41/5.7.1/0085 PHARMA DYNAMICS 41/7.5/0093 DR REDDY S 41/7.5/0094 DR REDDY S 41/7.5/0095 DR REDDY S 41/7.5/0096 DR REDDY S VIVAXIM RIFIZID 150/75 DYNA-CETIRIZINE SYRUP SIMZOR 10 mg SIMZOR 20 mg SIMZOR 40 mg SIMZOR 80 mg LAMIVUDINE 150,0 mg STAVUDINE 30,0 mg LAMIVUDINE 150,0 mg STAVUDINE 40,0 mg MELOXICAM 7,5 mg MELOXICAM 15 mg CARVEDILOL 25,0 mg CARVEDILOL 6,25 mg CARVEDILOL EACH 1,0 ml DOSE SALMONELLA TYPHI VI POLYSACCHARIDE (TY2 STRAIN) 25,0 μg HEPATITIS A VIRUS 160,0 antigen units RIFAMPICIN 150,0 mg ISONIAZID 75,0 mg EACH 1,0 ml SYRUP CETIRIZINE DIHYDROCHLORIDE 1,0 mg SIMVASTATIN 10,0 mg SIMVASTATIN 20,0 mg SIMVASTATIN 40,0 mg SIMVASTATIN 80,0 mg Notification of Apr08 v1.doc June 2008 Page 4 of 9
5 41/7.1.3/0110 AUROBINDO PHARMA 41/7.1.3/0111 AUROBINDO PHARMA 41/7.1.3/0125 ARROW PHARMA 41/7.1.3/0126 ARROW PHARMA 41/7.1.3/0127 ARROW PHARMA 41/7.1.3/0128 ARROW PHARMA AURO-LISINOPRIL CO 10 mg AURO-LISINOPRIL CO 20 mg VEDIBLOK 3,125 mg VEDIBLOK 6,25 mg VEDIBLOK VEDIBLOK 25 mg LISINOPRIL 10,0 mg LISINOPRIL 20,0 mg CARVEDILOL 3,125 mg CARVEDILOL 6,25 mg CARVEDILOL CARVEDILOL 25,0 mg 41/16/0190 PHARMACARE LIMITED ANDOSEPT-CO EACH 15,0 ml SOLUTION BENZYDAMINE HYDROCHLORIDE 22,5 mg CHLORHEXIDINE GLUCONATE 18,0 mg 41/7.3/0245 PHARMACARE LIMITED TRIPTAM 100 mg SUMATRIPTAM 100,0 mg 41/26/0246 ACCORD HEALTHCARE 41/20.2.8/0254 NOVARTIS SOUTH AFRICA 41/21.12/0268 DR REDDY S 41/26/0304 ACCORD HEALTHCARE 41/26/0305 ACCORD HEALTHCARE 41/26/0306 ACCORD HEALTHCARE 41/20.2.8/0330 ADCOCK INGRAM LIMITED FLORACOR 50 mg/ml INJECTION SEBIVO FINIDE METHACOR 5 mg/ml METHACOR 25 mg/ml METHACOR 100 mg/ml RETLAM SOLUTION FLUOROURACIL 50,0 mg TELBIVUDINE 600,0 mg FINASTERIDE 1,0 mg METHOTREXATE 5,0 mg METHOTREXATE 25,0 mg METHOTREXATE 100,0 mg LAMIVUDINE 10,0 mg Notification of Apr08 v1.doc June 2008 Page 5 of 9
6 41/1.2/0394 CIPLA MEDPRO (PTY) 41/1.2/0395 CIPLA MEDPRO (PTY) 41/1.2/0396 CIPLA MEDPRO (PTY) 41/3.2/0432 RANBAXY (SA) (PTY) 41/3.2/0433 RANBAXY (SA) (PTY) 41/3.2/0434 RANBAXY (SA) (PTY) 41/26/0435 ACCORD HEALTHCARE 41/7.5/0549 DR REDDY S 41/7.5/0550 DR REDDY S 41/7.5/0551 DR REDDY S 41/7.5/0552 DR REDDY S 41/1.2/0584 AUROBINDO PHARMA 41/1.2/0585 AUROBINDO PHARMA 41/7.1.3/0673 CIPLA LIFE SCIENCES LEXAMIL 5 LEXAMIL 10 LEXAMIL 20 BONIRAN 70 mg RAN-ALENDRONATE 10 RAN-ALENDRONATE 70 ACCORD- CARBOPLATIN 10 mg/ml INJECTION REDICOR 10 mg REDICOR 20 mg REDICOR 40 mg REDICOR 80 mg ZOLID 50 mg ZOLID 100mg CIPLA-PERINDOPRIL 2 mg ESCITALOPRAM OXALATE ESCITALOPRAM 5,0 mg ESCITALOPRAM OXALATE ESCITALOPRAM 10,0 mg ESCITALOPRAM OXALATE ESCITALOPRAM 20,0 mg SODIUM ALENDRONATE ALENDRONIC ACID 70,0 mg SODIUM ALENDRONATE ALENDRONIC ACID 10,0 mg SODIUM ALENDRONATE ALENDRONIC ACID 70,0 mg CARBOPLATIN 10.0 mg SIMVASTATIN 10,0 mg SIMVASTATIN 20,0 mg SIMVASTATIN 40,0 mg SIMVASTATIN 80,0 mg SERTRALINE HYDROCHLORIDE SERTRALINE 50,0 mg SERTRALINE HYDROCHLORIDE SERTRALINE 100,0 mg PERINDOPRIL ERBUMINE 2,0 mg Notification of Apr08 v1.doc June 2008 Page 6 of 9
7 41/7.1.3/0674 CIPLA LIFE SCIENCES 41/7.1.3/0675 CIPLA LIFE SCIENCES 41/20.1.2/0687 AUROBINDO PHARMA 41/20.1.2/0688 AUROBINDO PHARMA 41/2.5/0711 ZYDUS HEALTHCARE S.A. 41/2.5/0712 ZYDUS HEALTHCARE S.A. 41/2.5/0713 ZYDUS HEALTHCARE S.A. CIPLA-PERINDOPRIL 4 mg CIPLA-PERINDOPRIL 8 mg YOMAX 250 mg YOMAX 500 mg EPITOZ 25 EPITOZ 50 EPITOZ 100 PERINDOPRIL ERBUMINE 4,0 mg PERINDOPRIL ERBUMINE 8,0 mg EACH CAPSULE AMOXYCILLIN TRIHYDRATE AMOXYCILLIN 250,0 mg EACH CAPSULE AMOXYCILLIN TRIHYDRATE AMOXYCILLIN 500,0 mg TOPIRAMATE 25,0 mg TOPIRAMATE 50,0 mg TOPIRAMATE 100,0 mg 41/20.2.3/0723 SVIZERA SA RITIB RIFAMPICIN 150,0 mg ISONIAZID 75,0 mg ETHAMBUTOL HYDROCHLORIDE 275,0 mg PYRAZINAMIDE 400,0 mg 41/2.5/0724 RANBAXY (S.A.) (PTY) 41/2.5/0725 RANBAXY (S.A.) (PTY) 41/2.5/0726 RANBAXY (S.A.) (PTY) 41/20.1.1/0751 AUROBINDO PHARMA 41/20.1.1/0752 AUROBINDO PHARMA 41/20.1.1/0753 AUROBINDO PHARMA 41/7.1/0754 AUROBINDO PHARMA NEUSEIZE 100 mg NEUSEIZE 300 mg NEUSEIZE 400 mg ZINOXIME 125 mg ZINOXIME 250 mg ZINOXIME 500 mg AURO-AMLODIPINE TABLETS 5 mg EACH CAPSULE GABAPENTIN 100,0 mg EACH CAPSULE GABAPENTIN 300,0 mg EACH CAPSULE GABAPENTIN 400,0 mg CEFUROXIME AXETIL CEFUROXIME 125,0 mg CEFUROXIME AXETIL CEFUROXIME 250,0 mg CEFUROXIME AXETIL CEFUROXIME 500,0 mg AMLODIPINE BESILATE AMLODIPINE 5,0 mg Notification of Apr08 v1.doc June 2008 Page 7 of 9
8 41/7.1/0755 AUROBINDO PHARMA 41/7.3/0788 ARROW PHARMA 41/20.2.8/0806 AUROBINDO PHARMA 41/10.2.1/0849 INGELHEIM PHARMACEUTICALS 41/7.3/0861 ARROW PHARMA AURO-AMLODIPINE TABLETS 10 mg MIGRESS 50 LAZAVIR TABLETS SPIRIVA RESPIMAT MIGRESS /20.1.1/0866 SANDOZ S.A. SANDOZ CEFTRIAXONE 0,5 g 41/20.1.1/0867 SANDOZ S.A. SANDOZ CEFTRIAXONE 1,0 g 41/20.1.1/0868 SANDOZ S.A. SANDOZ CEFTRIAXONE 2,0 g AMLODIPINE BESILATE AMLODIPINE 10,0 mg SUMATRIPTAN SUCCINATE SUMATRIPTAN 50,0 mg LAMIVUDINE 150,0 mg ZIDOVUDINE 300,0 mg EACH DOSE TIOTROPIUM 5,0 μg SUMATRIPTAN SUCCINATE SUMATRIPTAN 100,0 mg EACH VIAL CEFTRIAXONE 0,5 g EACH VIAL CEFTRIAXONE 1,0 g EACH VIAL CEFTRIAXONE 2,0 g 41/20.1.1/0869 SANDOZ S.A. ROKEF 0,5 g EACH VIAL CEFTRIAXONE 0,5 g 41/20.1.1/0870 SANDOZ S.A. ROKEF 1,0 g EACH VIAL CEFTRIAXONE 1,0 g 41/20.1.1/0871 SANDOZ S.A. ROKEF 2,0 g EACH VIAL CEFTRIAXONE 2,0 g 41/20.1.1/0872 ORCHID PHARMACEUTICALS SA 41/20.1.1/0873 ORCHID PHARMACEUTICALS SA ORZID 1 g ORZID 2 g EACH VIAL CEFTAZIDIME PENTAHYDRATE CEFTAZIDIME 1,0 g EACH VIAL CEFTAZIDIME PENTAHYDRATE CEFTAZIDIME 2,0 g Notification of Apr08 v1.doc June 2008 Page 8 of 9
9 41/7.1.3/1050 AUROBINDO PHARMA 41/7.1.3/1051 AUROBINDO PHARMA 41/21.12/1054 AUROBINDO PHARMA 41/21.12/1055 AUROBINDO PHARMA LISINOZIDE 10 mg LISINOZIDE 20 mg AURO-FINASTERIDE TABLETS 5 mg PROFINA 5 mg 41/20.1.1/1063 SANDOZ S.A. SANDOZ CEFOTAXIME 0,5 g 41/20.1.1/1064 SANDOZ S.A. SANDOZ CEFOTAXIME 1,0 g LISINOPRIL 10,0 mg LISINOPRIL 20,0 mg FINASTERIDE 5,0 mg FINASTERIDE 5,0 mg EACH VIAL CEFOTAXIME SODIUM CEFOTAXIME 0,5 g EACH VIAL CEFOTAXIME SODIUM CEFOTAXIME 1,0 g 41/20.1.1/1065 SANDOZ S.A. CLATAX 0,5 g EACH VIAL CEFOTAXIME SODIUM CEFOTAXIME 0,5 g 41/20.1.1/1066 SANDOZ S.A. CLATAX 1,0 g EACH VIAL CEFOTAXIME SODIUM CEFOTAXIME 1,0 g 42/7.1.3/0106 RANBAXY (SA) (PTY) 42/7.1.3/0107 RANBAXY (SA) (PTY) PERIVAS 4 RAN-PERINDOPRIL 4 PERINDOPRIL TERT- BUTYLAMINE 4,0 mg PERINDOPRIL TERT- BUTYLAMINE 4,0 mg REGISTRAR OF MEDICINES MS MANDISA HELA Notification of Apr08 v1.doc June 2008 Page 9 of 9
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