MEDICINES CONTROL COUNCIL

Transcription

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) 41/20.1.1/0039 SCP MYLAN CEFAZOLIN 1 g CEFAZOLIN SODIUM CEFAZOLIN 1,0 g 41/7.1.3/0504 PHARMACARE LIMITED VERSYLON 2 mg PERINDOPRIL TERT- BUTYLAMINE 2,0 mg 41/7.1.3/0505 PHARMACARE LIMITED VERSYLON 4 mg PERINDOPRIL TERT- BUTYLAMINE 4,0 mg 41/7.1.3/0506 PHARMACARE LIMITED VERSYLON 8 mg PERINDOPRIL TERT- BUTYLAMINE 8,0 mg 41/21.2/0658 ACCORD HEALTHCARE 41/11.4.3/0663 ACCORD HEALTHCARE 41/25/0756 B BRAUN MEDICAL (PTY) ACCORD GLIMEPIRIDE 4 ACCORD OMEPRAZOLE 40 mg INJECTION NUTRIFLEX LIPID PLUS GLIMEPIRIDE 4,0 mg OMEPRAZOLE 40,0 mg L-isoleucine 2,26 g L-leucine 3,01 g L-methionine 1,88 g L-lysine 2,18 g L-phenylalanine 3,37 g L-threonine 1,74 g L-tryptophan 0,54 g L-valine 2,50 g L-arginine 2,59 g L-histidine 1,20 g L-alanine 4,66 g Glycine 1,58 g L-proline 3,26 g Notification of Feb11v1.doc Apr 2011 Page 1 of 8

2 41/25/0757 B BRAUN MEDICAL (PTY) 41/25/0758 B BRAUN MEDICAL (PTY) NUTRIFLEX LIPID PERI NUTRIFLEX LIPID PLUS WITHOUT ELECTROLYTES L-serine 2,88 g Sodium chloride 0,402 g Calcium chloride 0,47 g Magnesium acetate 0,686 g Potassium acetate 2,747 g Sodium dihydrogen phosphate 1,872 g Glucose 1 Aspartic acid 1,44 g Glutamic acid 3,37 g Sodium hydroxide 0,781 g Sodium acetate 0,222 g Zinc acetate 5,264 g Soya oil L-isoleucine 1,87 g L-leucine 2,50 g L-methionine 1,57 g L-lysine 1,81 g L-phenylalanine 2,81 g L-threonine 1,46 g L-tryptophan 0,46 g L-valine 2,08 g L-arginine 2,16 g L-histidine 1,00 g L-alanine 3,88 g Glycine 1,32 g L-proline 2,72 g L-serine 2,40 g Sodium chloride 0,865 g Calcium chloride 0,353 g Magnesium acetate 0,515 g Potassium acetate 2,354 g Sodium dihydrogen phosphate 0,936 g Glucose 64,0 g Aspartic acid 1,20 g Glutamic acid 2,80 g Sodium hydroxide 0,64 g Sodium acetate 0,435 g Zinc acetate 5,30 g Soya oil L-isoleucine 2,26 g L-leucine 3,01 g L-methionine 1,88 g L-lysine 2,18 g L-phenylalanine 3,37 g L-threonine 1,74 g L-tryptophan 0,54 g Notification of Feb11v1.doc Apr 2011 Page 2 of 8

3 41/25/0759 B BRAUN MEDICAL (PTY) 42/7.1.3/0325 ACCORD HEALTHCARE 42/7.1.3/0326 ACCORD HEALTHCARE NUTRIFLEX LIPID SPECIAL LOSAAR PLUS 50/12,5 LOSAAR PLUS 100/25 L-valine 2,50 g L-arginine 2,59 g L-histidine 1,20 g L-alanine 4,66 g Glycine 1,58 g L-proline 3,26 g L-serine 2,88 g Glucose 1 Aspartic acid 1,44 g Glutamic acid 3,37 g Soya oil L-isoleucine 3,28 g L-leucine 4,38 g L-methionine 2,74 g L-lysine 3,18 g L-phenylalanine 4,92 g L-threonine 2,54 g L-tryptophan 0,80 g L-valine 3,60 g L-arginine 3,78 g L-histidine 1,75 g L-alanine 6,79 g Glycine 2,31 g L-proline 4,76 g L-serine 4,20 g Sodium chloride 0,378 g Calcium chloride 0,623 g Magnesium acetate 0,91 g Potassium acetate 3,689 g Sodium dihydrogen phosphate 2,496 g Glucose 144,0 g Aspartic acid 2,10 g Glutamic acid 4,91 g Sodium hydroxide 1,171 g Sodium acetate 0,25 g Zinc acetate 7,02 g Soya oil 12,5 mg Notification of Feb11v1.doc Apr 2011 Page 3 of 8

4 42/5.7.1/0339 SANOFI-AVENTIS 43/20.2.8/0581 ARROW PHARMA 44/20.2.8/0106 ADCOCK INGRAM LIMITED 44/20.2.8/0107 ADCOCK INGRAM LIMITED A40/3/0326 A40/3/0327 ECO ECO 41/26/0162 CIPLA LIFE SCIENCES 41/26/0163 CIPLA LIFE SCIENCES 41/1.2/0297 BOUWER BARTLETT 41/26/0423 CIPLA MEDPRO (PTY) 41/26/0424 CIPLA MEDPRO (PTY) 41/26/0425 CIPLA MEDPRO (PTY) 41/25/0760 B BRAUN MEDICAL (PTY) TELFAST SUSPENSION ARROW EFAVIRENZ ADCO LAMIVUDINE AND ZIDOVUDINE 150/300 ZILAM TABLETS MICROVISC MICROVISC PLUS CIPLA DOCETAXEL 20 CIPLA DOCETAXEL 80 GLENMARK CITALOPRAM 20 mg CIPLA PACLITAXEL 30 mg/5 ml CIPLA PACLITAXEL 100 mg/16,7 ml CIPLA PACLITAXEL 300 mg/50 ml NUTRIFLEX LIPID SPEICAL WITHOUT ELECTROLYTES Each 5,0 ml suspension FEXOFENADINE HYDROCHLORIDE 30,0 mg EFAVIRENZ 600,0 mg LAMIVUDINE 1 ZIDOVUDINE 300,0 mg LAMIVUDINE 1 ZIDOVUDINE 300,0 mg Each 1,0 ml solution SODIUM HYALURONATE 10,0 mg Each 1,0 ml solution SODIUM HYALURONATE 14,0 mg DOCETAXEL 20,0 mg DOCETAXEL 80,0 mg CITALOPRAM HYDROBROMIDE CITALOPRAM 20,0 mg Each 5,0 ml vial PACLITAXEL 30,0 mg Each 20,0 ml vial PACLITAXEL Each 50,0 ml vial PACLITAXEL 300,0 mg L-isoleucine 3,28 g L-leucine 4,38 g L-methionine 2,74 g L-lysine 3,18 g L-phenylalanine 4,92 g L-threonine 2,54 g L-tryptophan 0,80 g L-valine 3,60 g L-arginine 3,78 g L-histidine 1,75 g L-alanine 6,79 g Glycine 2,31 g L-proline 4,76 g L-serine 4,20 g Glucose 144,0 g Aspartic acid 2,10 g Glutamic acid 4,91 g Notification of Feb11v1.doc Apr 2011 Page 4 of 8

5 41/3.1/0762 PFIZER LABORATORIES 41/3.1/0763 PFIZER LABORATORIES 41/11.5/0764 ARROW PHARMA 41/7.1/0782 MERCK GENERICS RSA 41/7.1/0783 MERCK GENERICS RSA ENBREL 25 mg PS ENBREL 50 mg PS ANLAC SYRUP MERCK AMLODIPINE 5 MERCK AMLODIPINE 10 41/5.2/0990 PHARMACARE LIMITED ASPEN GALANTAMINE 12 mg 41/5.2/0991 PHARMACARE LIMITED ASPEN GALANTAMINE 8 mg Soya oil Each pre-filled syringe ETANERCEPT Each pre-filled syringe ETANERCEPT Each 5,0 ml syrup LACTULOSE 5,0 mg AMLODIPINE BESYLATE AMLODIPINE 5,0 mg AMLODIPINE BESYLATE AMLODIPINE 10,0 mg GALANTAMINE 12,0 mg GALANTAMINE 8,0 mg 41/7.1.3/1000 SPECPHARM NETRASOL CO 50 12,5 mg 41/7.1.3/1001 SPECPHARM NETRASOL CO /5.3/1015 SANDOZ S.A. GALANTIC 4 GALANTAMINE HYDROBROMIDE GALANTAMINE 4,0 mg 41/5.3/1016 SANDOZ S.A. GALANTIC 8 GALANTAMINE HYDROBROMIDE GALANTAMINE 8,0 mg 41/5.3/1017 SANDOZ S.A. GALANTIC 12 GALANTAMINE HYDROBROMIDE GALANTAMINE 12,0 mg 41/7.1.3/1031 RANBAXY (S.A.) (PTY) RAN LOSARTAN PLUS 12,5mg Notification of Feb11v1.doc Apr 2011 Page 5 of 8

6 41/7.1.3/1034 RANBAXY (S.A.) (PTY) 41/7.1.3/1035 RANBAXY (S.A.) (PTY) 41/7.1.3/1036 RANBAXY (S.A.) (PTY) RAN LOSARTAN FORTE PLUS LOHYPE PLUS 50/12,5 LOHYPE FORTE PLUS 100/25 42/26/0020 PHARMACARE LIMITED ASPEN VINORELBIN 10 mg/1 ml 42/26/0021 PHARMACARE LIMITED ASPEN VINORELBIN 50 mg/5 ml 42/20.1.1/0079 XIXIA 42/20.1.1/0080 XIXIA 42/20.1.1/0081 XIXIA 42/5.7.1/0344 WINTHROP 42/3.2/0452 SANOFI AVENTIS SA MYLAN CEFTAZIDIME 500 mg MYLAN CEFTAZIDIME 1 g MYLAN CEFTAZIDIME 2 g FEXOFENADINE- WINTHROP SUSPENSION 6 mg/ml ACTONEL 75 mg 12,5 mg Each 1,0 ml vial VINORELBINE TARTRATE VINORELBINE 10,0 mg Each 5,0 ml vial VINORELBINE TARTRATE VINORELBINE CEFTAZIDIME PENTAHYDRATE CEFTAZIDIME 500,0 mg CEFTAZIDIME PENTAHYDRATE CEFTAZIDIME 1,0 g CEFTAZIDIME PENTAHYDRATE CEFTAZIDIME 2,0 g Each 5,0 ml suspension FEXOFENADINE HYDROCHLORIDE 30,0 mg RISEDRONATE SODIUM 75,0 mg 42/34/0664 PHARMAPLAN ZOBONE ZOLEDRONIC ACID 4,0 mg 42/20.2.8/0687 MSD ISENTRESS RALTEGRAVIR POTASSIUM RALTEGRAVIR 400,0 mg Notification of Feb11v1.doc Apr 2011 Page 6 of 8

7 42/20.2.8/0838 PHARMACARE LIMITED ASPEN ATAZANAVIR 150 mg 42/20.2.8/0839 PHARMACARE LIMITED ASPEN ATAZANAVIR 200 mg Each capsule ATAZANAVIR 1 Each capsule ATAZANAVIR 200,0 mg 42/1.2/1001 PHARMAPLAN NEXITO 10 ESCITALOPRAM OXALATE ESCITALOPRAM 10,0 mg 42/11.4.3/1003 ASTRAZENECA 43/20.2.8/0230 BLISS cc 43/20.2.8/0234 DEZZO TRADING 392 t/a INDO PHARMA 43/20.2.8/0235 DEZZO TRADING 392 t/a INDO PHARMA 43/20.2.8/0236 DEZZO TRADING 392 t/a INDO PHARMA 43/2.2/0247 AUROBINDO PHARMA 43/2.2/0257 AUROBINDO PHARMA 43/7.1.3/0493 AUROBINDO PHARMA 43/7.1.3/0494 AUROBINDO PHARMA 43/7.1.3/0495 AUROBINDO PHARMA 43/7.1.3/0496 AUROBINDO PHARMA 43/7.1.3/0497 AUROBINDO PHARMA 43/7.1.3/0498 AUROBINDO PHARMA NEXIAM 10 mg SACHETS NEVIVIR ATAZOR 100 ATAZOR 150 ATAZOR 200 MEDPLOZ 5 mg MEDPLOZ 10 mg AURO LOSARTAN TABLETS 25 mg AURO LOSARTAN TABLETS 50 mg AURO LOSARTAN TABLETS 100 mg RASOL 25 RASOL 50 RASOL 100 Each sachet ESOMEPRAZOLE 10,0 mg NEVIRAPINE 200,0 mg Each capsule ATAZANAVIR Each capsule ATAZANAVIR 1 Each capsule ATAZANAVIR 200,0 mg ZOLPIDEM TARTRATE 5,0 mg ZOLPIDEM TARTRATE 10,0 mg Notification of Feb11v1.doc Apr 2011 Page 7 of 8

8 43/20.2.8/0580 ARROW PHARMA 43/20.1.1/0647 JANSSEN PHARMACEUTICA (PTY) 43/18.8/0648 PHARMA DYNAMICS 43/20.1.6/0680 GLENMARK 43/30.1/0944 ROCHE PRODUCTS 43/30.1/0945 ROCHE PRODUCTS 43/30.1/0946 ROCHE PRODUCTS 44/20.2.8/0108 ADCOCK INGRAM LIMITED VIREF DORIBAX 500 mg RUBY SUPIROBAN ACTEMRA 80 ACTEMRA 200 ACTEMRA 400 PROPAN LAMIVUDINE AND ZIDOVUDINE 150/300 EFAVIRENZ 600,0 mg DORIPENEM MONOHYDRATE DORIPENEM 500,0 mg DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,03 mg Each 1,0 g ointment MUPIROCIN 2,0 mg Each 4,0 ml solution TOCILIZUMAB 80,0 mg Each 4,0 ml solution TOCILIZUMAB 200,0 mg Each 4,0 ml solution TOCILIZUMAB 400,0 mg LAMIVUDINE 1 ZIDOVUDINE 300,0 mg REGISTRAR OF MEDICINES MS MANDISA HELA Notification of Feb11v1.doc Apr 2011 Page 8 of 8