MEDICINES CONTROL COUNCIL

Notification of of Medicines 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) 06/21.9/15 VIRBAC RSA RILEXINE ORAL PASTE 31/7.5/0516 TEVA TEVA-GEMFIBROZIL 600 mg EACH 1,0 g PASTE CEPHALEXIN MONOHYDRATE CEPHALEXIN 200,0 mg GEMFIBROZIL 600,0 mg 36/30.3/0344 JE ECKARD OCTANATE 250 EACH VIAL FACTOR VIII 250,0 I.U. 36/30.3/0345 JE ECKARD OCTANATE 500 EACH VIAL FACTOR VIII 500,0 I.U. 36/30.3/0346 JE ECKARD OCTANATE 1 000 EACH VIAL FACTOR VIII 1 000,0 I.U. 37/30.3/0645 JE ECKARD OCTANINE F 250 EACH VIAL FACTOR IX 250,0 I.U. 37/30.3/0646 JE ECKARD OCTANINE F 500 EACH VIAL FACTOR IX 500,0 I.U. 37/30.3/0647 JE ECKARD OCTANINE F 1 000 EACH VIAL FACTOR IX 1 000,0 I.U. 38/7.1.3/0117 EGIS SOUTH AFRICA COVERON 8 mg BUTYLAMINE 8,0 mg 12.39 Notification of Feb08v2.doc Apr 2008 Page 1 of 6

Notification of of Medicines 38/7.1.3/0118 EGIS SOUTH AFRICA CIRCATOR 8 mg 38/20.1.1/0235 SANDOZ SA SANDOZ ROXITHROMYCIN 150 38/20.1.1/0236 SANDOZ SA SANDOZ ROXITHROMYCIN 300 A38/15.1/0647 CARE LIMITED CHLORAMPHENICOL EYE DROPS BP 0,5 % w/v A39/7.1.3/0244 A39/8.5/0374 ASTRAZENECA KEY ONCOLOGICS (PTY) LTD ATACAND 32 mg THROMBOREDUCTIN 0,5 mg A39/20.1.1/0397 SANDOZ SA SANDOZ CEFPODOXIME 40 mg/5 ml A39/20.1.1/0398 SANDOZ SA SANDOZ CEFPODOXIME 100 A39/20.2.8/0445 STRIDES S.A. DAS-NEVIRAPINE 200 mg BUTYLAMINE 8,0 mg ROXITHROMYCIN 150,0 mg ROXITHROMYCIN 300,0 mg CHLORAMPHENICOL 5,0 mg CANDESARTAN CILEXETIL 32,0 mg EACH CAPSULE ANAGRELIDE HYDROCHLORIDE ANAGRELIDE 0,5 mg CEFPODOXIME PROXETIL CEFPODOXIME 40,0 mg CEFPODOXIME PROXETIL CEFPODOXIME 100,0 mg NEVIRAPINE 200,0 mg A39/2.1/0447 PLAN PROVIVE 1 % EACH 1,0 ml EMULSION PROPOFOL 10,0 mg A39/2.6.5/0478 SANDOZ RISPERIDONE HEXAL 1 mg A39/2.6.5/0479 SANDOZ RISPERIDONE HEXAL 2 mg A39/2.6.5/0480 SANDOZ RISPERIDONE HEXAL 3 mg A39/2.6.5/0481 SANDOZ RISPERIDONE HEXAL 4 mg A39/21.5.1/0506 A39/21.5.1/0507 ASTRAZENECA ASTRAZENECA SYMBICORD RAPIHALER 80:4,5 SYMBICORD RAPIHALER 160:4,5 RISPERIDONE 1,0 mg RISPERIDONE 2,0 mg RISPERIDONE 3,0 mg RISPERIDONE 4,0 mg EACH ACTUATION DELIVERS: BUDESONIDE 80,0 μg FORMOTEROL FUMARATE 4,5 μg EACH ACTUATION DELIVERS: BUDESONIDE 160,0 μg FORMOTEROL FUMARATE 4,5 μg 12.39 Notification of Feb08v2.doc Apr 2008 Page 2 of 6

Notification of of Medicines A40/11.10/0049 RECKITT BENCKISER GAVISCON ADVANCE PEPPERMINT SODIUM ALGINATE 500,0 mg A40/30.2/0061 MERCK ERBITUX 2 mg/ml CETUXIMAB 2,0 mg A40/2.7/0092 RECKITT BENCKISER NUROFEN FOR CHILDREN STRAWBERRY IBUPROFEN 100,0 mg A40/20.2.2/0115 PLAN EXOMAX EACH 100,0 ml SOLUTION FLUCONAZOLE 200,0 mg A40/20.2.8/0148 STRIDES SA STRIDES-LAMIVUDINE 150 mg AND ZIDOVUDINE 300 mg LAMIVUDINE 150,0 mg ZIDOVUDINE 300,0 mg A40/20.2/0157 PLAN METRIS METRONIDAZOLE 5,0 mg A40/2.9/0190 UNICHEM S.A. DOMADOL 50 mg TRAMADOL HYDROCHLORIDE 50,0 mg A40/2.9/0191 UNICHEM S.A. DOMADOL 100 mg TRAMADOL HYDROCHLORIDE 100,0 mg A40/34/0239 A40/20.2.8/0277 A40/20.2.8/0278 A40/20.2.8/0279 TRINITY (PTY) LTD BRISTOL-MYERS SQUIBB BRISTOL-MYERS SQUIBB BRISTOL-MYERS SQUIBB A40/201.2/0286 DEZZO TRADING (392) t/a INDO A40/21.2/0464 DEZZO TRADING (392) t/a INDO A40/21.2/0465 DEZZO TRADING (392) t/a INDO TAXUS LIBERTE MONORAIL PACLITAXEL-ELUTING CORONARY STENT SYSTEM BARACLUDE 0,5 mg TABLET BARACLUDE 1,0 mg TABLET BARACLUDE ORAL SOLUTION 0,05 mg/ml INDO FLUCLOXACILLIN-250 DIAMIN-500 DIAMIN-850 EACH mm 2 PACLITAXEL 0,001 mg ENTECAVIR 0,5 mg ENTECAVIR 1,0 mg ENTECAVIR 0,05 mg EACH CAPSULE FLUCLOXACILLIN SODIUM FLUCLOXACILLIN 250,0 mg METFORMIN HYDROCHLORIDE 500,0 mg METFORMIN HYDROCHLORIDE 850,0 mg 12.39 Notification of Feb08v2.doc Apr 2008 Page 3 of 6

Notification of of Medicines A40/20.2.8/0490 AUROBINDO A40/20.2.3/0543 DEZZO TRADING (392) t/a INDO A40/20.2.8/0561 A40/5.10/0572 A40/5.10/0573 AUROBINDO ADCOCK INGRAM CRITICAL CARE ADCOCK INGRAM CRITICAL CARE AURO-NEVIRAPINE ORAL SUSPENSION 50 mg/5 ml RIFIZID 300/150 AURO-LAMIVUDINE ORAL SOLUTION 10 mg/ml SABAX ONDANSETRON INJECTION 4 mg/2 ml SABAX ONDANSETRON INJECTION 8 mg/4 ml A40/5.7.1/0590 SANDOZ SA SANDOZ FEXOFENADINE 120 A40/5.7.1/0591 SANDOZ SA SANDOZ FEXOFENADINE 180 A40/28/0679 ALCON LABORATORIES (SA) FLUORESCITE 10 % NEVIRAPINE HEMIHYDRATE NEVIRAPINE 50,0 mg RIFAMPICIN 300,0 mg ISONIAZID 150,0 mg LAMIVUDINE 10,0 mg EACH 2,0 ml SOLUTION ONDANSETRON 4,0 mg EACH 4,0 ml SOLUTION ONDANSETRON 8,0 mg FEXOFENADINE HYDROCHLORIDE 120,0 mg FEXOFENADINE HYDROCHLORIDE 180,0 mg EACH 5,0 ml SOLUTION FLUORESCEIN 500,0 mg 41/21.8.2/0021 PLAN ESCAPELLE LEVONORGESTREL 1,5 mg 41/5.7.1/0086 DYNAMICS TEXA SYRUP EACH 1,0 ml SYRUP CETIRIZINE DIHYDROCHLORIDE 1,0 mg 41/30.1/0145 MSD GARDASIL EACH 0,5 ml DOSE HUMAN PAPILLOMA VIRUS: TYPE 6 L 1 PROTEIN 20,0 μg TYPE 11 L 1 PROTEIN 40,0 μg TYPE 16 L 1 PROTEIN 40,0 μg TYPE 18 L 1 PROTEIN 20,0 μg 41/26/0195 PFIZER LABORATORIES 41/26/0196 PFIZER LABORATORIES SUTENT 25 mg CAPSULE SUTENT 50mg CAPSULE EACH CAPSULE SUNITINIB MALEATE SUNITINIB 25,0 mg EACH CAPSULE SUNITINIB MALEATE SUNITINIB 50,0 mg 12.39 Notification of Feb08v2.doc Apr 2008 Page 4 of 6

Notification of of Medicines 41/26/0197 PFIZER LABORATORIES SUTENT 12,5 mg CAPSULE 41/21.12/0200 SANDOZ SA SANDOZ BICALUTAMIDE 50 EACH CAPSULE SUNITINIB MALEATE SUNITINIB 12,5 mg BICALUTAMIDE 50,0 mg 41/21.12/0201 SANDOZ SA BICADEX 50 BICALUTAMIDE 50,0 mg 41/20.2.8/0217 ABBOTT LABORATORIES S.A. 41/21.12/0222 CIPLA LIFE SCIENCES 41/30.1/0366 GLAXOSMITHKLINE SOUTH AFRICA 41/1.2/0401 CIPLA LIFE SCIENCES 41/1.2/0402 CIPLA LIFE SCIENCES 41/1.2/0403 CIPLA LIFE SCIENCES 41/3/0404 ALCON LABORATORIES (SA) 41/20.2.8/0541 AUROBINDO 41/20.2.8/0542 AUROBINDO 41/20.2.8/0543 AUROBINDO 41/7.5/0666 ZYDUS HEALTHCARE SA 41/7.5/0667 ZYDUS HEALTHCARE SA 41/7.5/0668 ZYDUS HEALTHCARE SA 41/7.5/0669 ZYDUS HEALTHCARE SA ALUVIA CIPLA-FINASTERIDE 1 mg CERVARIX CIPLA- ESCITALOPRAM 5 CIPLA- ESCITALOPRAM 10 CIPLA- ESCITALOPRAM 20 DISCOVISC AURO-EFAVIRENZ CAPSULES 50 mg AURO-EFAVIRENZ CAPSULES 100 mg AURO-EFAVIRENZ CAPSULES 200 mg ZYSIM 10 mg TABLETS ZYSIM 20 mg TABLETS ZYSIM 40 mg TABLETS ZYSIM 80 mg TABLETS LOPINAVIR 200,0 mg RITONAVIR 50,0 mg FINASTERIDE 1,0 mg EACH 0,5 ml DOSE HUMAN PAPILLOMA VIRUS: TYPE 16 L 1 PROTEIN 20,0 μg TYPE 18 L 1 PROTEIN 20,0 μg ESCITALOPRAM 5,0 mg ESCITALOPRAM 10,0 mg ESCITALOPRAM 20,0 mg SODIUM HYALURONATE 16,5 mg SODIUM CHONDROITIN SULPHATE 40,0 mg EACH CAPSULE EFAVIRENZ 50,0 mg EACH CAPSULE EFAVIRENZ 100,0 mg EACH CAPSULE EFAVIRENZ 200,0 mg SIMVASTATIN 10,0 mg SIMVASTATIN 20,0 mg SIMVASTATIN 40,0 mg SIMVASTATIN 80,0 mg 41/7.1.3/0694 PLAN PERISTAR 2 BUTYLAMINE 2,0 mg 12.39 Notification of Feb08v2.doc Apr 2008 Page 5 of 6

Notification of of Medicines 41/7.1.3/0695 PLAN PERISTAR 4 BUTYLAMINE 4,0 mg 41/7.1.3/0696 PLAN PERISTAR 8 BUTYLAMINE 8,0 mg 41/5.2/0740 SANOFI-SYNTHELABO ALFUZOSIN- WINTHROP 10 mg ALFUZOSIN HYDROCHLORIDE 10,0 mg 41/20.1.1/0918 SANDOZ S.A. KEFTAZ 0,5 g EACH VIAL 0,5 g 41/20.1.1/0919 SANDOZ S.A. KEFTAZ 1,0 g EACH VIAL 1,0 g 41/20.1.1/0920 SANDOZ S.A. KEFTAZ 2,0 g EACH VIAL 2,0 g 41/20.1.1/0921 SANDOZ S.A. SANDOZ 0,5 g 41/20.1.1/0922 SANDOZ S.A. SANDOZ 1,0 g 41/20.1.1/0923 SANDOZ S.A. SANDOZ 2,0 g 42/20.2.8/0014 RANBAXY (S.A.) SONKE-DIDANOSINE 25 42/20.2.8/0015 RANBAXY (S.A.) SONKE-DIDANOSINE 50 42/20.2.8/0016 RANBAXY (S.A.) SONKE-DIDANOSINE 100 42/20.2.8/0026 CARE LIMITED ASPEN EFAVIRENZ 600 mg REGISTRAR OF MEDICINES MS MANDISA HELA EACH VIAL 0,5 g EACH VIAL 1,0 g EACH VIAL 2,0 g DIDANOSINE 25,0 mg DIDANOSINE 50,0 mg DIDANOSINE 100,0 mg EFAVIRENZ 600,0 mg 12.39 Notification of Feb08v2.doc Apr 2008 Page 6 of 6