MEDICINES CONTROL COUNCIL - mccza.com

1 Administration Notification of registration of MEDICINES Notification of registration May 2010 Page 1 of 4 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) Application Number Holder of Certificate of registration Proprietary Name Active Compound 38 ADCOCK INGRAM LIMITED PARACETAMOL ADCO 1 000 Each sachet contains: PARACETAMOL 1 000,0 mg A38 SANOFI-AVENTIS SOUTH AFRICA (PTY) LTD EPILIM CHRONOSPHERE Each 100,0 g granules contain: SODIUM VALPROATE 22,0 g VALPROIC ACID 9,58 g A38 WINTHROP PHARMACEUTICALS (PTY) LTD VALPROWIN CHRONOSPHERE Each 100,0 g granules contain: SODIUM VALPROATE 22,0 g VALPROIC ACID 9,58 g A39 WINTHROP PHARMACEUTICALS (PTY) LTD EPILIZINE CR 300 BREAKABLE Each tablet contains: SODIUM VALPROATE 199,8 mg VALPROIC ACID 87,0 mg A39 WINTHROP PHARMACEUTICALS (PTY) LTD EPILIZINE CR 500 BREAKABLE Each tablet contains: SODIUM VALPROATE 333,0 mg VALPROIC ACID 145,0 mg A39 SANOFI-AVENTIS SOUTH AFRICA (PTY) LTD EPILIM CR 300 BREAKABLE Each tablet contains: SODIUM VALPROATE 199,8 mg VALPROIC ACID 87,0 mg A39 SANOFI-AVENTIS SOUTH AFRICA (PTY) LTD EPILIM CR 500 BREAKABLE Each tablet contains: SODIUM VALPROATE 333,0 mg VALPROIC ACID 145,0 mg A39 WINTHROP PHARMACEUTICALS (PTY) LTD VALPIREX CR 300 BREAKABLE Each tablet contains: SODIUM VALPROATE 199,8 mg VALPROIC ACID 87,0 mg A39 WINTHROP PHARMACEUTICALS (PTY) LTD VALPIREX CR 500 BREAKABLE Each tablet contains.

2 SODIUM VALPROATE 333,0 mg VALPROIC ACID 145,0 mg Administration Notification of registration of MEDICINES Notification of registration May 2010 Page 2 of 4 Application Number Holder of Certificate of registration Proprietary Name Active Compound A39 MERCK (PTY) LTD ILIADIN PRESERVATIVE-FREE 0,05 % METERED SPRAY Each 1,0 ml solution contains: OXYMETAZOLINE 0,5 mg A39 MERCK (PTY) LTD ILIADIN PRESERVATIVE-FREE 0,025 % METERED SPRAY Each 1,0 ml solution contains: OXYMETAZOLINE 0,25 mg A40 SPECPHARM (PTY) LTD MACOREL 30 SR Each tablet contains: NIFEDIPINE 30,0 mg A40 SPECPHARM (PTY) LTD MACOREL 60 SR Each tablet contains: NIFEDIPINE 60,0 mg A40 SPECPHARM (PTY) LTD SPEC NIFEDIPINE 30 SR Each tablet contains: NIFEDIPINE 30,0 mg A40 SPECPHARM (PTY) LTD SPEC NIFEDIPINE 60 SR Each tablet contains: NIFEDIPINE 60,0 mg 41 TRINITY PHARMA (PTY) LTD FAMYNOR Each tablet contains: NORGESTREL 0,5 mg ETHINYL ESTRADIOL 0,05 mg 41 ADCOCK INGRAM LIMITED STAID 20 mg Each capsule contains: STAVUDINE 20,0 mg 41 ADCOCK INGRAM LIMITED STAID 30 mg Each capsule contains: STAVUDINE 30,0 mg 41 ADCOCK INGRAM LIMITED STAID 40 mg Each capsule contains: STAVUDINE 40,0 mg 41 ADCOCK INGRAM LIMITED ADCO STAVUDINE 20 mg Each capsule contains: STAVUDINE 20,0 mg 41 ADCOCK INGRAM LIMITED ADCO STAVUDINE 30 mg Each capsule contains: STAVUDINE 30,0 mg 41 ADCOCK INGRAM LIMITED ADCO STAVUDINE 40 mg Each capsule contains: STAVUDINE 40,0 mg 41 SPECPHARM (PTY) LTD PEARINDA PLUS 2 Each tablet contains: PERINDOPRIL, TERT-BUTYLAMINE 2,0 mg INDAPAMIDE 0,625 mg 41 SPECPHARM (PTY) LTD PEARINDA PLUS 4 Each tablet contains.

3 PERINDOPRIL, TERT-BUTYLAMINE 4,0 mg INDAPAMIDE 1,25 mg 41 BE-TABS PHARMACEUTICALS (PTY) LTD PARAPYN Each tablet contains: PARACETAMOL 500,0 mg 41 AUROBINDO PHARMA (PTY) LTD ZYNOVIR CAPSULES 100 mg Each capsule contains: ZIDOVUDINE 100,0 mg 41 AUROBINDO PHARMA (PTY) LTD ZYNOVIR CAPSULES 250 mg Each capsule contains: ZIDOVUDINE 250,0 mg 41 SOLVAY PHARMA (PTY) LTD TRICOR 160 mg Each tablet contains: FENOFIBRATE 160,0 mg 41/26/0915 PHARMACORP cc GENEXOL 100 mg Each vial contains: PACLITAXEL 100,0 mg Administration Notification of registration of MEDICINES Notification of registration May 2010 Page 3 of 4 Application Number Holder of Certificate of registration Proprietary Name Active Compound 41 AUROBINDO PHARMA (PTY) LTD COLAZID Each tablet contains: LAMIVUDINE 150,0 mg ZIDOVUDINE 300,0 mg 41 AUROBINDO PHARMA (PTY) LTD BAVIR TABLETS 300 mg Each tablet contains: ABACAVIR SULPHATE equivalent to ABACAVIR 300,0 mg 41/26/0924 PHARMACORP cc GENEXOL 30 mg Each vial contains: PACLITAXEL 30,0 mg 42 AUROBINDO PHARMA (PTY) LTD BINDOPIN TABLETS 200 mg Each tablet contains: NEVIRAPINE 200,0 mg 42 AUROBINDO PHARMA (PTY) LTD ZENVIR TABLETS 600 mg Each tablet contains: EFAVIRENZ 600,0 mg 42 RANBAXY ( ) (PTY) LTD ZELIVIRE 500 Each tablet contains: VALACICLOVIR HYDROCHLORIDE equivalent to VALACICLOVIR 500,0 mg 42 RANBAXY ( ) (PTY) LTD RAN VALACICLOVIR 500 Each tablet contains: VALACICLOVIR HYDROCHLORIDE EQUIVALENT TO VALACICLOVIR 500,0 mg 42 CIPLA MEDPRO (PTY) LTD DONECEPT 5 Each tablet contains: DONEPEZIL HYDROCHLORIDE equivalent to DONEPEZIL 5,0 mg 42 CIPLA MEDPRO (PTY) LTD DONECEPT 10 Each tablet contains.

4 DONEPEZIL HYDROCHLORIDE equivalent to DONEPEZIL 10,0 mg 42/34/0699 BAROQUE PHARMACEUTICALS (PTY) LTD XIENCE V Each stent contains: EVEROLIMUS 100,0 g/cm2 42 PHARMA DYNAMICS (PTY) LTD ZYTOMIL 5 mg Each tablet contains: ESCITALOPRAM OXALATE equivalent to ESCITALOPRAM 5,0 mg 42 PHARMA DYNAMICS (PTY) LTD ZYTOMIL 10 mg Each tablet contains: ESCITALOPRAM OXALATE equivalent to ESCITALOPRAM 10,0 mg 42 PHARMA DYNAMICS (PTY) LTD ZYTOMIL 15 mg Each tablet contains: ESCITALOPRAM OXALATE equivalent to ESCITALOPRAM 15,0 mg 42 PHARMA DYNAMICS (PTY) LTD ZYTOMIL 20 mg Each tablet contains: ESCITALOPRAM OXALATE equivalent to ESCITALOPRAM 20,0 mg 42 AUROBINDO PHARMA (PTY) LTD BINDOLAM ORAL SOLUTION 10 mg/ml Each 1,0 ml solution contains: LAMIVUDINE 10,0 mg 43 AUROBINDO PHARMA (PTY) LTD AURO RIBAVIRIN TABLETS 200 mg Each tablet contains: RIBAVIRIN 200,0 mg Administration Notification of registration of MEDICINES Notification of registration May 2010 Page 4 of 4 Application Number Holder of Certificate of registration Proprietary Name Active Compound 43 AUROBINDO PHARMA (PTY) LTD DORIK TABLETS 200 mg Each tablet contains: RIBAVIRIN 200,0 mg 43 RANBAXY ( ) (PTY) LTD SONKE TENOFOVIR 300 Each tablet contains: TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 44 AUROBINDO PHARMA (PTY) LTD STABINEZ 600 mg TABLETS Each tablet contains: EFAVIRENZ 600,0 mg 44 AUROBINDO PHARMA (PTY) LTD APAFAR 600 mg TABLETS Each tablet contains: EFAVIRENZ 600,0 mg 44 AUROBINDO PHARMA (PTY) LTD ZEFIN 300 mg TABLETS Each tablet contains: TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 44 AUROBINDO PHARMA (PTY) LTD CYLOR 300 mg TABLETS Each tablet contains.

5 TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 44 AUROBINDO PHARMA (PTY) LTD VIRENO 300 mg TABLETS Each tablet contains: TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 44 AUROBINDO PHARMA (PTY) LTD DELADEX 200 mg CAPSULES Each capsule contains: DIDANOSINE 200,0 mg 44 AUROBINDO PHARMA (PTY) LTD DELADEX 250 mg CAPSULES Each capsule contains: DIDANOSINE 250,0 mg 44 AUROBINDO PHARMA (PTY) LTD DELADEX 400 mg CAPSULES Each capsule contains: DIDANOSINE 400,0 mg 44 AUROBINDO PHARMA (PTY) LTD SEGIREF 200 mg CAPSULES Each capsule contains: DIDANOSINE 200,0 mg 44 AUROBINDO PHARMA (PTY) LTD SEGIREF 250 mg CAPSULES Each capsule contains: DIDANOSINE 250,0 mg 44 AUROBINDO PHARMA (PTY) LTD SEGIREF 400 mg CAPSULES Each capsule contains: DIDANOSINE 400,0 mg 44 AUROBINDO PHARMA (PTY) LTD SONIREN 200 mg CAPSULES Each capsule contains: DIDANOSINE 200,0 mg 44 AUROBINDO PHARMA (PTY) LTD SONIREN 250 mg CAPSULES Each capsule contains: DIDANOSINE 250,0 mg 44 AUROBINDO PHARMA (PTY) LTD SONIREN 400 mg CAPSULES Each capsule contains: DIDANOSINE 400,0 mg REGISTRAR OF MEDICINES MS MANDISA HELA