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) 06/1.3/04 MC PHARMA (PTY) THIANIL/TREXONIL COMBIPACK Each pack contains: THIANIL VIAL containing: THIAFENTANIL OXALATE 10,0 mg/1,0 ml TREXONIL VIAL containing: NALTREXONE HYDROCHLORIDE /1,0 ml 06/1.3/05 MC PHARMA (PTY) TREXONIL Each vial contains: NALTREXONE HYDROCHLORIDE /1,0 ml 06/1.3/06 MC PHARMA (PTY) THIANIL Each vial contains: THIAFENTANIL OXALATE 10,0 mg/1,0 ml 34/21.5.1/0343 SCHERING-PLOUGH (PTY) 34/21.5.1/0344 SCHERING-PLOUGH (PTY) 37/5.8/0139 JOHNSON & JOHNSON (PTY) ASMANEX TWISTHALER 200 µg ASMANEX TWISTHALER 400 µg SINUTAB SINUS PAIN EXTRA STRENGTH Each inhalation delivers: MOMETASONE FUROATE 200,0 µg Each inhalation delivers: MOMETASONE FUROATE 400,0 µg PARACETAMOL 500,0 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30,0 mg CHLORPHENIRAMINE MALEATE 2,0 mg CODEINE PHOSPHATE 10,0 mg 38/11.5/0166 PHARMACARE AGAROL LACTULOSE Each 5,0 ml syrup contains: LACTULOSE 3,3 mg 38/2.7/0261 WYETH S.A. (PTY) ADVIL LIQUI-GEL 400 IBUPROFEN 400,0 mg 12.48 Notification of Aug09v1.doc September 2009 Page 1 of 5

Notification of of Medicines A39/3.2/0352 A39/30.3/0591 A39/30.3/0592 A39/30.3/0593 A39/34/0647 A40/5.10/0323 A40/5.10/0324 A40/5.10/0325 A40/2.6.5/0527 A40/2.6.5/0528 A40/2.6.5/0529 A40/26/0609 A40/26/0610 A40/26/0611 PHARMACO DISTRIBUTION (PTY) ASTELLAS PHARMA (PTY) SUPLASYN 250 I.U. 500 I.U. 1 000 I.U. PROGRAF 0,5 mg SABAX COVAN PROPAN RESKIT 0,5 RESKIT 1 RESKIT 2 PCH-PACLITAXEL 30 PCH-PACLITAXEL 100 PCH-PACLITAXEL 300 A40/2.6.5/0674 SANDOZ SA (PTY) SANDOZ RISPERIDONE 1 A40/2.6.5/0675 SANDOZ SA (PTY) SANDOZ RISPERIDONE 2 A40/2.6.5/0676 SANDOZ SA (PTY) SANDOZ RISPERIDONE 3 A40/2.6.5/0677 SANDOZ SA (PTY) SANDOZ RISPERIDONE 4 A40/2.5/0768 A40/2.5/0769 A40/2.5/0770 S.A. (PTY) S.A. (PTY) S.A. (PTY) 50 mg TABLETS 100 mg TABLETS 200 mg TABLETS Each pre-filled syringe contains: SODIUM HYALURONATE 20,0 mg 250,0 I.U. 500,0 I.U. 1 000,0 I.U. TACROLIMUS 0,5 mg 4,0 mg 4,0 mg 4,0 mg RISPERIDONE 0,5 mg RISPERIDONE 1,0 mg RISPERIDONE 2,0 mg RISPERIDONE 1,0 mg RISPERIDONE 2,0 mg RISPERIDONE 3,0 mg RISPERIDONE 4,0 mg LAMOTRIGINE LAMOTRIGINE LAMOTRIGINE 200,0 mg 12.48 Notification of Aug09v1.doc September 2009 Page 2 of 5

Notification of of Medicines 41/7.1.3/0041 S.A. (PTY) 41/5.7.1/0119 GULF DRUG COMPANY (PTY) 41/26/0160 CIPLA LIFE SCIENCES (PTY) 41/26/0161 CIPLA LIFE SCIENCES (PTY) ZYDUS LISINOPRIL/HYDRO- CHLOROTHIAZIDE 20/12,5 mg LORMEG 10 CIPLA-CISPLATIN 10 CIPLA-CISPLATIN 50 LISINOPRIL DIHYDRATE LISINOPRIL 20,0 mg HYDROCHLOROTHIAZIDE 12,5 mg LORATADINE 10,0 mg Each 20,0 ml vial contains: CISPLATIN 10,0 mg Each 50,0 ml vial contains: CISPLATIN 41/21.5.1/0243 PHARMACARE REDIPRED Each 5,0 ml liquid contains: PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE 15,0 mg 41/7.1.3/0499 AUSTELL 41/7.1.3/0500 AUSTELL 41/7.1.3/0501 AUSTELL 41/7.1.3/0502 AUSTELL 41/7.1.3/0503 AUSTELL 41/7.1.3/0517 AUSTELL 41/7.1.5/0644 ELI LILLY (S.A.) (PTY) 41/7.1.5/0645 ELI LILLY (S.A.) (PTY) 41/7.1/0659 ACCORD HEALTHCARE (PTY) 41/7.1/0660 ACCORD HEALTHCARE (PTY) 41/20.2.8/0808 AUROBINDO PHARMA (PTY) 41/20.2.8/0809 AUROBINDO PHARMA (PTY) AUSTOZAAR 25 AUSTOZAAR 50 AUSTOZAAR 100 LORTELL-25 LORTELL-50 LORTELL-100 CIALIS 5 CIALIS 2,5 AMTAS 5 AMTAS 10 AURO-STAVUDINE 15 mg AURO-STAVUDINE 20 mg TADALAFIL 5,0 mg TADALAFIL 2,5 mg AMLODIPINE BESYLATE AMLODIPINE 5,0 mg AMLODIPINE BESYLATE AMLODIPINE 10,0 mg STAVUDINE 15,0 mg STAVUDINE 20,0 mg 41/30.2/0883 MERCK (PTY) ERBITUX 5 mg/ml CETUXIMAB 5,0 mg 12.48 Notification of Aug09v1.doc September 2009 Page 3 of 5

Notification of of Medicines 41/26/1002 ACCORD HEALTHCARE (PTY) 41/20.1.1/1018 AUSTELL 41/20.1.1/1019 AUSTELL ACCORD VINCRISTINE 1 mg/ml INJECTION AUSTELL 250 mg AUSTELL 500 mg VINCRISTINE SULPHATE 1,0 mg HEMIHYDRATE 2 HEMIHYDRATE 500,0 mg 41/7.1.3/1074 SPECPHARM (PTY) SPEC LOSARTAN 25 : 41/7.1.3/1075 SPECPHARM (PTY) SPEC LOSARTAN 100 41/7.1.3/1076 SPECPHARM (PTY) SPEC LOSARTAN 50 41/7.1.3/1077 SPECPHARM (PTY) SPEC LOSARTAN 12,5 12,5 mg 41/26/1095 SANDOZ SA (PTY) LOXAT 30 Each vial contains: PACLITAXEL 30,0 mg 41/26/1096 SANDOZ SA (PTY) LOXAT 100 Each vial contains: PACLITAXEL 41/26/1097 SANDOZ SA (PTY) LOXAT 300 Each vial contains:: PACLITAXEL 300,0 mg 41/2.9/1103 MEDWICH PHARMA (PTY) 41/2.9/1104 MEDWICH PHARMA (PTY) 41/2.9/1105 MEDWICH PHARMA (PTY) 42/30.1/0118 SANOFI-AVENTIS SOUTH AFRICA (PTY) OXYNORM 5 mg OXYNORM 10 mg OXYNORM 20 mg ADACEL QUADRA HYDROCHLORIDE 5,0 mg HYDROCHLORIDE 10,0 mg HYDROCHLORIDE 20,0 mg Each 0,5 dose contains: DIPHTHERIA TOXOID 2,0 Lf PERTUSSIS TOXOID 2,5 µg FILAMENTOUS HAEMAGGLUTININ 5,0 µg FIMBRIAE TYPE 2+3 5,0 µg PERTACTIN 3,0 µg TETANUS TOXOID 5,0 Lf TYPE 1 40 D-antigen units TYPE 2 8 D-antigen units TYPE 3 32 D-antigen units 12.48 Notification of Aug09v1.doc September 2009 Page 4 of 5

Notification of of Medicines 42/26/0132 SANDOZ SA (PTY) SANDOZ VINORELBINE 10 mg/1 ml 42/26/0133 SANDOZ SA (PTY) SANDOZ VINORELBINE 50 mg/5 ml Each vial contains: VINORELBINE 10,0 mg Each vial contains: VINORELBINE 42/26/0134 SANDOZ SA (PTY) NEUVEL 10 mg/1 ml Each vial contains: VINORELBINE 10,0 mg 42/26/0135 SANDOZ SA (PTY) NEUVEL 50 mg/5 ml Each vial contains: VINORELBINE 42/5.7.1/0143 PHARMACARE ASPEN CETIRIZINE 1 mg/ml 42/20.2.2/0446 GLENMARK PHARMACEUTICALS SOUTH AFRICA (PTY) GLENMARK TERBINAFINE 250 CETIRIZINE DIHYDROCHLORIDE 1,0 mg TERBINAFINE to TERBINAFINE 2 42/20.1.1/0592 BAYER (PTY) MOXIBAY IV Each 250,0 ml solution contains: to 400,0 mg 42/20.1.1/0593 BAYER (PTY) MOXIBAY TABLETS to 400,0 mg 42/20.1.1/0594 BAYER (PTY) BAYQUIN TABLETS to 400,0 mg 42/20.1.1/0595 BAYER (PTY) BAYQUIN IV Each 250,0 ml solution contains: to 400,0 mg MS MANDISA HELA REGISTRAR OF MEDICINES 12.48 Notification of Aug09v1.doc September 2009 Page 5 of 5