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) 07/ /23 NOVARTIS SA ONSIOR INJECTION Each 1,0 ml solution contains: ROBENACOXIB 20,0 mg 37/15.4/0224 SOFLENS LIPOSIC EYE GEL Each 1,0 g gel contains: CARBOMER 2,0 mg 37/15.2/0588 SOFLENS LOTEMAX OPHTHALMIC SUSPENSION A39/7.1/0419 A39/7.1/0420 A39/7.1/0421 A39/7.1/0422 A39/7.1/0423 APEX 1 mg APEX 2 mg APEX 5 mg APEX 10 mg APEX BPH STARTER PACK Each 1,0 mg suspension contains: LOTEPREDNOL ETABONATE 5,0 mg to 1,0 mg to 2,0 mg to 5,0 mg to 10,0 mg Each pack contains: 3 x APEX 1 mg TABLETS containing to 1,0 mg 11 x APEX 2 mg TABLETS containing to 2,0 mg 12.67_Notification_of Jul12_v1 Aug 2012 Page 1 of 11
2 A39/7.1/0424 A39/7.1/0425 A39/7.1/0426 A39/7.1/0427 A39/7.1/0428 A40/4/0214 ADCOCK INGRAM CRITICAL CARE (PTY) 41/26/0034 CIPLA MEDPRO (PTY) 41/26/0035 CIPLA MEDPRO (PTY) 41/5.10/0241 SAFELINE 41/5.10/0242 SAFELINE 41/20.1.1/0947 WINTHROP 41/20.1.1/0948 WINTHROP TERAPRESS BPH STARTER PACK TERAPRESS 1 mg TERAPRESS 2 mg TERAPRESS 5 mg TERAPRESS 10 mg SABAX BUPIVACAINE 0,1 % VIAFLEX CIPLA DOXORUBICIN 10 CIPLA DOXORUBICIN 50 SAFELINE 4 mg INJECTION SAFELINE 8 mg INJECTION WINTHROP 200 WINTHROP 400 Each pack contains: 3 x TERAPRESS 1 mg TABLETS containing to 1,0 mg 11 x TERAPRESS 2 mg TABLETS containing to 2,0 mg to 1,0 mg to 2,0 mg to 5,0 mg to 10,0 mg Each 1 000,0 ml solution contains: BUPIVACAINE HYDROCHLORIDE 1,0 g DOXORUBICIN HYDROCHLORIDE 10,0 mg DOXORUBICIN HYDROCHLORIDE 50,0 mg HYDROCHLORIDE DIHYDRATE 4,0 mg HYDROCHLORIDE DIHYDRATE 8,0 mg 200,0 mg 400,0 mg 12.67_Notification_of Jul12_v1 Aug 2012 Page 2 of 11
3 41/20.1.1/0949 SANOFI-AVENTIS 41/20.1.1/0950 SANOFI-AVENTIS 41/34/1134 WINTHROP 41/34/1135 SANOFI-AVENTIS SANOFI-AVENTIS 200 SANOFI-AVENTIS 400 WINTHROP SOLVENT SANOFI-AVENTIS SOLVENT 200,0 mg 400,0 mg WATER FOR INJECTION 3,0 ml WATER FOR INJECTION 3,0 ml 42/28/0102 COVIDIEN OPTIMARK 10 Each 10,0 ml contains: GADOVERSETAMIDE 3 309,0 mg 42/28/0103 COVIDIEN OPTIMARK 15 Each 15,0 ml contains: GADOVERSETAMIDE 4 963,5 mg 42/28/0104 COVIDIEN OPTIMARK 20 Each 20,0 ml contains: GADOVERSETAMIDE 6 618,0 mg 42/28/0105 COVIDIEN OPTIMARK 30 Each 30,0 ml contains: GADOVERSETAMIDE 9 927,0 mg 42/7.1.3/0262 PHARMACARE TRANDOPRESS 2 mg Each capsule contains: TRANDOLAPRIL 2,0 mg 42/20.1.1/0427 SPECPHARM LEVOFLOXACIN SPECPHARM 250 IV 42/20.1.1/0428 SPECPHARM SPEC LEVOFLOXACIN 500 IV 42/20.1.1/0439 SPECPHARM LEVOFLOXACIN SPECPHARM 500 IV 42/20.1.1/0440 SPECPHARM SPEC LEVOFLOXACIN 250 IV 42/20.1.1/0505 CIPLA MEDPRO (PTY) 42/20.1.2/0771 ADCOCK INGRAM 42/34/0786 ASTELLAS PHARMA 42/34/0787 ASTELLAS PHARMA 42/34/0788 ASTELLAS PHARMA 42/2.5/0810 ADCOCK INGRAM ZITRO 500 TABLETS ADCO AMOXYCLAV BD ADVAGRAF 0,5 mg ADVAGRAF 1 mg ADVAGRAF 5 mg RESTAN TOPIRAMATE 25 mg AZITHROMYCIN DIHYDRATE AZITHROMYCIN 500,0 mg AMOXYCILLIN TRIHYDRATE AMOXYCILLIN 875,0 mg POTASSIUM CLAVULANATE CLAVULANIC ACID 125,0 mg Each capsule contains: TACROLIMUS 0,5 mg Each capsule contains: TACROLIMUS 1,0 mg Each capsule contains: TACROLIMUS 5,0 mg TOPIRAMATE 25,0 mg 12.67_Notification_of Jul12_v1 Aug 2012 Page 3 of 11
4 42/2.5/0811 ADCOCK INGRAM 42/2.5/0812 ADCOCK INGRAM 42/2.5/0813 ADCOCK INGRAM 42/21.12/0995 ZYDUS HEALTHCARE SA RESTAN TOPIRAMATE 50 mg RESTAN TOPIRAMATE 100 mg RESTAN TOPIRAMATE 200 mg CASTRA 1 42/21.12/1037 PHARMACARE ASPEN ANASTROZOLE 43/21.2/0002 WINTHROP 43/21.2/0003 WINTHROP 43/21.2/0004 SANOFI-AVENTIS 43/21.2/0005 SANOFI AVENTIS GLAMARYL COMBI 1/250 GLAMARYL COMBI 2/500 AMARYL COMBI 1/250 AMARYL COMBI 2/500 TOPIRAMATE 50,0 mg TOPIRAMATE 100,0 mg TOPIRAMATE 200,0 mg Each tablet contain: ANASTROZOLE 1,0 mg ANASTROZOLE 1,0 mg GLIMEPIRIDE 1,0 mg HYDROCHLORIDE 250,0 mg GLIMEPIRIDE 2,0 mg HYDROCHLORIDE 500,0 mg GLIMEPIRIDE 1,0 mg HYDROCHLORIDE 250,0 mg GLIMEPIRIDE 2,0 mg HYDROCHLORIDE 500,0 mg 43/21.12/0074 SANDOZ SA ANAMAST 1 mg ANASTROZOLE 1,0 mg 43/5.7.1/0079 ADCOCK INGRAM 43/26/0102 PHARMACHEMIE (PTY) 43/26/0103 PHARMACHEMIE (PTY) 43/30.1/0127 GLAXOSMITHKLINE SA 43/21.2/0140 ACCORD HEALTHCARE ADCO DESLORATADINE SYRUP OXALIPLATIN PCH 50 OXALIPLATIN PCH 100 PRIORIX TETRA ACCORD PIOGLITAZONE 15 mg Each 5,0 ml syrup contains: DESLORATADINE 2,5 mg Each 10 ml vial contains: OXALIPLATIN 50 mg Each 20 ml vial contains: OXALIPLATIN 100 mg Each 0,5 ml contains: LIVE ATTENTUATED MEASLES VIRUS (SCHWARZ STRAIN) CCID 50 LIVE ATTENUATED MUMPS VIRUS (RIT4385 STRAIN) CCID 50 LIVE ATTENUATED RUBELLA VIRUS (WISTAR RA 27/3 STRAIN) CCID 50 LIVE ATTENUATED VARICELLA VIRUS (OKA STRAIN) PFU PIOGLITAZONE to PIOGLITAZONE 15,0 mg 12.67_Notification_of Jul12_v1 Aug 2012 Page 4 of 11
5 43/21.2/0141 ACCORD HEALTHCARE 43/21.2/0142 ACCORD HEALTHCARE ACCORD PIOGLITAZONE 30 mg ACCORD PIOGLITAZONE 45 mg PIOGLITAZONE to PIOGLITAZONE 30,0 mg PIOGLITAZONE to PIOGLITAZONE 45,0 mg 43/20.1.1/0310 PHARMACARE BACTRICEF 1 g CEFEPIME HYDROCHLORIDE CEFEPIME 1 000,0 mg 43/20.2.8/0433 ROCHE PRODUCTS 43/5.10/0542 FRESENIUS KABI SOUTH AFRICA 43/5.10/0543 FRESENIUS KABI SOUTH AFRICA 43/5.4.1/0622 AKACIA HEALTHCARE 43/5.4.1/0623 AKACIA HEALTHCARE 43/5.4.1/0624 AKACIA HEALTHCARE 43/5.4.1/0625 AKACIA HEALTHCARE 43/5.4.1/0626 AKACIA HEALTHCARE 43/7.1.3/0652 ARROW PHARMA 43/7.1.3/0653 ARROW PHARMA 43/7.1.3/0654 ARROW PHARMA VALCYTE 50 mg/ml FRESENIUS 2 mg/ml (4 mg/2 ml) FRESENIUS 2 mg/ml (8 mg/4 ml) PRAMEX 0,5 PRAMEX 0,25 PRAMEX 0,125 PRAMEX 1,0 PRAMEX 1,5 PERIPREX 2/0,625 PERIPREX 4/1,25 ARIPREL PLUS 2/0,625 Each 1,0 ml solution contains: VALGANCICLOVIR to VALGANCICLOVIR 50,0 mg HYDROCHLORIDE DIHYDRATE 4,0 mg HYDROCHLORIDE DIHYDRATE 8,0 mg PRAMIPEXOLE DIHYDROCHLORIDE 0,5 mg PRAMIPEXOLE DIHYDROCHLORIDE 0,25 mg PRAMIPEXOLE DIHYDROCHLORIDE 0,125 mg PRAMIPEXOLE DIHYDROCHLORIDE 1,0 mg PRAMIPEXOLE DIHYDROCHLORIDE 1,5 mg PERINDOPRIL TERT- BUTYLAMINE 2,0 mg INDAPAMIDE 0,625 mg PERINDOPRIL TERT- BUTYLAMINE 4,0 mg INDAPAMIDE 1,25 mg PERINDOPRIL TERT- BUTYLAMINE 2,0 mg INDAPAMIDE 0,625 mg 12.67_Notification_of Jul12_v1 Aug 2012 Page 5 of 11
6 43/7.1.3/0655 ARROW PHARMA 43/32.16/0681 B BRAUN MEDICAL (PTY) 43/30.1/0727 JANSSEN PHARMACEUTICA (PTY) 43/30.1/0728 JANSSEN PHARMACEUTICA (PTY) 43/20.1.1/0783 ADCOCK INGRAM 43/20.1.1/0784 ADCOCK INGRAM 43/5.7.1/0814 DR REDDY S LABORATORIES (PTY) 43/5.7.1/0815 DR REDDY S LABORATORIES (PTY) 43/2.5/0840 GULF DRUG COMPANY ARIPREL PLUS 4/1,25 SEQUENT PLEASE STELARA 45 mg STELARA 90 mg LEVOTAV IV 250 LEVOTAV IV 500 CETLEV 5 DRL LEVOCETIRIZINE 5 GULF CARBAMAZEPINE 200 PERINDOPRIL TERT- BUTYLAMINE 4,0 mg INDAPAMIDE 1,25 mg Each mm 2 surface contains: PACLITAXEL 3,0 µg USTEKINUMAB 45,0 mg USTEKINUMAB 90,0 mg LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg CARBAMAZEPINE 200,0 mg 43/20.1.1/0859 SANDOZ SA CLARIHEXAL 500 XL CLARITHROMYCIN 500,0 mg 43/20.1.1/0860 SANDOZ SA SANDOZ CLARITHROMYCIN 500 XL 43/20.1.1/0955 SCP 43/20.1.1/0956 SCP MYLAN CIPROFLOXACIN 200 mg/100 ml MYLAN CIPROFLOXACIN 400 mg/200 ml 43/21.2/1055 NOVARTIS SA GALVUS MET 50 mg/850 mg 43/21.2/1056 NOVARTIS SA GALVUS MET 50 mg/1 000 mg 43/7.1/1127 SANOFI-AVENTIS 43/7.1/1128 SANOFI-AVENTIS TRITACE PLUS 2,5/12,5 mg TRITACE PLUS 5/12,5 mg CLARITHROMYCIN 500,0 mg CIPROFLOXACIN 200,0 mg Each 200,0 ml solution contains: CIPROFLOXACIN 400,0 mg VILDAGLIPTIN 50,0 mg HYDROCHLORIDE 850,0 mg VILDAGLIPTIN 50,0 mg HYDROCHLORIDE 1 000,0 mg RAMIPRIL 2,5 mg 12,5 mg RAMIPRIL 5,0 mg 12,5 mg 12.67_Notification_of Jul12_v1 Aug 2012 Page 6 of 11
7 43/7.1/1129 SANOFI-AVENTIS 43/7.1/1130 SANOFI-AVENTIS 43/7.1/1131 SANOFI-AVENTIS TRITACE PLUS 10/12,5 mg TRITACE PLUS 5/25 mg TRITACE PLUS 10/25 mg 44/7.1.3/0075 NOVARTIS SA CO EXFORGE 5 mg/160 mg/12,5 mg 44/7.1.3/0076 NOVARTIS SA CO EXFORGE 5 mg/160 mg/25 mg 44/7.1.3/0077 NOVARTIS SA CO EXFORGE 10 mg/160 mg/12,5 mg 44/7.1.3/0078 NOVARTIS SA CO EXFORGE 10 mg/160 mg/25 mg 44/7.1.3/0079 NOVARTIS SA CO EXFORGE 10 mg/320 mg/25 mg 44/10.2.2/0200 WINTHROP 44/10.2.2/0201 WINTHROP MONTEWIN 5 mg MONTEWIN 10 mg RAMIPRIL 10,0 mg 12,5 mg RAMIPRIL 5,0 mg 25,0 mg RAMIPRIL 10,0 mg 25,0 mg AMLODIPINE BESYLATE AMLODIPINE 5,0 mg VALSARTAN 160,0 mg 12,5 mg AMLODIPINE BESYLATE AMLODIPINE 5,0 mg VALSARTAN 160,0 mg 25,0 mg AMLODIPINE BESYLATE AMLODIPINE 10,0 mg VALSARTAN 160,0 mg 12,5 mg AMLODIPINE BESYLATE AMLODIPINE 10,0 mg VALSARTAN 160,0 mg 25,0 mg AMLODIPINE BESYLATE AMLODIPINE 10,0 mg VALSARTAN 320,0 mg 25,0 mg 12.67_Notification_of Jul12_v1 Aug 2012 Page 7 of 11
8 44/20.1.1/0220 ADCOCK INGRAM 44/20.1.1/0221 ADCOCK INGRAM 44/20.1.1/0222 ADCOCK INGRAM 44/20.1.1/0223 ADCOCK INGRAM 44/20.1.1/0224 ADCOCK INGRAM 44/20.1.1/0225 ADCOCK INGRAM 44/10.2.2/0257 TRINITY PHARMA SA 44/10.2.2/0262 TRINITY PHARMA SA 44/10.2.2/0286 TRINITY PHARMA SA PROPAN 250 mg PROPAN 500 mg RESTAN 250 mg RESTAN 500 mg COVAN 250 mg COVAN 500 mg MONTEFLO 4 MONTEFLO 5 MONTEFLO 10 44/1.3.2/0339 PHARMAPLAN ALTREX NALTREXONE HYDROCHLORIDE 50,0 mg 44/10.2.2/0384 WINTHROP (PTY)D MONTEWIN 4 mg 44/10.2.2/0431 PHARMACARE LEUKOBLOC 10 mg 44/10.2.2/0493 AKACIA HEALTHCARE 44/10.2.2/0494 AKACIA HEALTHCARE 44/10.2.2/0495 AKACIA HEALTHCARE MINAIR 4 MINAIR 5 MINAIR _Notification_of Jul12_v1 Aug 2012 Page 8 of 11
9 44/20.1.1/0582 ALKEM LABORATORIES 44/20.1.1/0583 ALKEM LABORATORIES ZOCEF 250 mg ZOCEF 500 mg 44/10.2.2/0666 MSD MSD MONTELUKAST 4 mg 44/10.2.2/0667 MSD MSD MONTELUKAST 5 mg 44/10.2.2/0668 MSD MSD MONTELUKAST 10 mg 44/10.2.2/0669 MSD MSD MONTELUKAST SPRINKLES 44/10.2.2/0844 BRIMPHARM SA (PTY) 44/10.2.2/0845 BRIMPHARM SA (PTY) 44/10.2.2/0846 BRIMPHARM SA (PTY) MONTELUKAST BRIMPHARM 4 MONTELUKAST BRIMPHARM 5 MONTELUKAST BRIMPHARM 10 44/10.2.2/0889 SPECPHARM MONTELUKAST SPECPHARM 4 44/10.2.2/0890 SPECPHARM MONTELUKAST SPECPHARM 5 44/10.2.2/0891 SPECPHARM MONTELUKAST SPECPHARM 10 44/2.5/0924 GULF DRUG COMPANY 45/10.2.2/0058 RANBAXY (S.A.) (PTY) GDC CARBAMAZEPINE 200 DILAIR 4 CEFUROXIME AXETIL CEFUROXIME 250,0 mg CEFUROXIME AXETIL CEFUROXIME 500,0 mg Each packet contains: MONTELUKAST 4,0 mg CARBAMAZEPINE 200,0 mg 12.67_Notification_of Jul12_v1 Aug 2012 Page 9 of 11
10 45/10.2.2/0059 RANBAXY (S.A.) (PTY) 45/10.2.2/0060 RANBAXY (S.A.) (PTY) 45/20.2.8/0082 AUROBINDO PHARMA 45/20.2.8/0083 AUROBINDO PHARMA 45/20.1.1/0216 ALKEM LABORATORIES 45/20.1.1/0217 ALKEM LABORATORIES 45/30.2/0431 GLAXOSMITHKLINE 45/20.2.8/0537 MACLEODS SA 45/20.2.8/0766 CIPLA MEDPRO (PTY) 45/20.2.8/0767 MEDPRO PHARMACEUTICA (PTY) 45/20.2.8/0815 CIPLA MEDPRO (PTY) DILAIR 5 DILAIR 10 COTIRAL 100/25 mg TABLETS COTIRAL 200/50 mg TABLETS CEFUROXIME ALKEM 250 mg CEFUROXIME ALKEM 500 mg GSK PNEUMOCOCCAL VACCINE MACLEODS EFAVIRENZ 600 mg CIPLA LAMIVUDINE 30 mg MEDPRO LAMIVUDINE 30 mg NEVIRAPINE MEDPRO 50 mg TABLETS FOR ORAL SUSPENSION LOPINAVIR 100,0 mg RITONAVIR 25,0 mg LOPINAVIR 200,0 mg RITONAVIR 50,0 mg CEFUROXIME AXETIL CEFUROXIME 250,0 mg CEFUROXIME AXETIL CEFUROXIME 500,0 mg Each 0,5 ml dose contains: SEROTYPE 1 1,0 µg SEROTYPE 5 1,0 µg SEROTYPE 6B 1,0 µg SEROTYPE 7F 1,0 µg SEROTYPE 9V 1,0 µg SEROTYPE 14 1,0 µg SEROTYPE 23F 1,0 µg SEROTYPE 4 3,0 µg SEROTYPE 18C 3,0 µg SEROTYPE 19F 3,0 µg EFAVIRENZ 600,0 mg LAMIVUDINE 30 mg LAMIVUDINE 30 mg NEVIRAPINE 50,0 mg 12.67_Notification_of Jul12_v1 Aug 2012 Page 10 of 11
11 45/20.2.8/0816 CIPLA MEDPRO (PTY) 45/20.2.8/0817 CIPLA MEDPRO (PTY) 45/20.2.8/0818 CIPLA MEDPRO (PTY) 46/20.2.8/0039 WINTHROP 46/20.2.8/0040 WINTHROP NEVIRAPINE MEDPRO 100 mg TABLETS FOR ORAL SUSPENSION NEVIMUNE 50 mg TABLETS FOR ORAL SUSPENSION NEVIMUNE 100 mg TABLETS FOR ORAL SUSPENSION EFAVIRENZ WINTHROP TENOFOVIR WINTHROP NEVIRAPINE 100,0 mg NEVIRAPINE 50,0 mg NEVIRAPINE 100,0 mg EFAVIRENZ 600,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg MS MANDISA HELA REGISTRAR OF MEDICINES 12.67_Notification_of Jul12_v1 Aug 2012 Page 11 of 11
MEDICINES CONTROL COUNCIL
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