MEDICINES CONTROL COUNCIL NOTIFICATION OF REGISTRATION OF MEDICINES BY THE REGISTRAR IN TERMS OF SECTION 17 OF THE MEDICINES AND RELATED SUBSTANCES ACT 101 OF 1965 Application Number Holder of registration of Certificate Proprietary Name Active Compound 01/2.6/9 SCHERING-PLOUGH (PTY) 31/10.2.2/0470 COMPUPHARM (PTY) 36/1.2/0046 HEXAL PHARMA (SA) (PTY) 36/1.2/0047 HEXAL PHARMA (SA) (PTY) 36/7.5/0213 HEXAL PHARMA (SA) (PTY) 36/7.5/0214 HEXAL PHARMA (SA) (PTY) 36/7.5/0215 HEXAL PHARMA (SA) (PTY) BANAMINE VENTA FLUVOHEXAL 50 FLUVOHEXAL 100 LIPIDEX 10 LIPIDEX 20 HEXAL-SIMVASTATIN 10 EACH 1,0 ml SOLUTION FLUNIXIN MEGLUMINE FLUNIXIN 50,0 EACH 1,0 ml AMPOULE SALBUTAMOL SULPHATE SALBUTAMOL 0,5 FLUVOXAMINE MALEATE 50,0 FLUVOXAMINE MALEATE 100,0 SIMVASTATIN 10,0 SIMVASTATIN 20,0 SIMVASTATIN 10,0 12.23 Notification of Registration 29 July 2005v2.doc - Feb 2006 Page 1 of 10
36/7.5/0216 HEXAL PHARMA (SA) (PTY) HEXAL-SIMVASTATIN 20 SIMVASTATIN 20,0 36/7.5/0280 COMPUPHARM (PTY) VALPHARMA BEZAFIBRATE SR BEZAFIBRATE 400,0 36/21.8.2/0454 PHARMAPLAN (PTY) CYPRENE-35 ED EACH PACK 21 HORMONAL CONTAINING: CYPROTERONE ACETATE 2,0 ETHINYLESTRADIOL 0,035 7 PLACEBO 36/7.1/0480 ALLIANCE PHARMA (PTY) 36/7.1/0481 ALLIANCE PHARMA (PTY) 36/20.2.3/0494 INNOVATA CC 36/20.2.3/0496 INNOVATA CC 36/20.2.3/0497 INNOVATA CC 36/22.1/0508 ADCOCK INGRAM CRITICAL CARE (PTY) 37/15.1/0082 ADCOCK INGRAM CPL ALLIANCE AMLODIPINE 5 CPL ALLIANCE AMLODIPINE 10 KOXIRIP MONTONEX 150 MONTONEX 300 CERNEVIT TOBRABACT AMLODIPINE BESYLATE AMLODIPINE 5,0 AMLODIPINE BESYLATE AMLODIPINE 10,0 RIFAMPICIN 120,0 ISONIAZID 60,0 PYRAZINAMIDE 300,0 ETHAMBUTOL 200,0 RIFAMPICIN 150,0 ISONIAZID 100,0 RIFAMPICIN 300,0 ISONIAZID 150,0 EACH VIAL RETINOL PALMITATE 3 500 iu CHOLECALCIFEROL 220 iu DL-ALPHA-TOCOPHEROL 10,20 ASCORBIC ACID 125,0 COCARBOXYLASE TETRAHYDRATE 5,80 RIBOFLAVIN SODIUM PHOSPHATE 5,67 PYRIDOXINE HYDROCHLORIDE 5,50 CYANOCOBALAMIN 0,006 FOLIC ACID 0,414 DEXPANTHENOL 16,150 D-BIOTIN 0,069 NICOTINAMIDE 46,00 EACH 1,0 ml SOLUTION TOBRAMYCIN 3,0 12.23 Notification of Registration 29 July 2005v2.doc - Feb 2006 Page 2 of 10
37/2.8/0097 37/1.2/0101 HEXAL PHARMA (SA) (PTY) 37/1.2/0102 HEXAL PHARMA (SA) (PTY) 37/2.6.5/0142 JANSSEN PHARMACEUTICA (PTY) 37/2.6.5/0143 JANSSEN PHARMACEUTICA (PTY) 37/2.6.5/0144 JANSSEN PHARMACEUTICA (PTY) 37/21.5.1/0146 CIPLA MEDPRO (PTY) 37/21.5.1/0147 CIPLA MEDPRO (PTY) -CO-CODAMOL PARACETAMOL 500,0 CODEINE PHOSPHATE 8,0 FLUVOXAMINE-HEXAL 50 FLUVOXAMINE MALEATE 50,0 FLUVOXAMINE-HEXAL 100 RISPERDAL CONSTA 25 RISPERDAL CONSTA 37,5 RISPERDAL CONSTA 50 CIPLA-FLUTICASONE 50 DP-CAPS CIPLA-FLUTICASONE 100 DP-CAPS FLUVOXAMINE MALEATE 100,0 EACH VIAL RISPERIDONE 25,0 EACH VIAL RISPERIDONE 37,5 EACH VIAL RISPERIDONE 50,0 FLUTICASONE PROPIONATE 50,0 ug FLUTICASONE PROPIONATE 100,0 ug 37/21.5.1/0148 CIPLA MEDPRO (PTY) 37/3.1/0234 ADCOCK INGRAM 37/3.1/0235 ADCOCK INGRAM CIPLA-FLUTICASONE 250 DP-CAPS ADCO-MELOXICAM 7,5 ADCO-MELOXICAM 15 FLUTICASONE PROPIONATE 250,0 ug MELOXICAM 7,5 MELOXICAM 15,0 37/3.1/0255 UNICHEM SA (PTY) M-CAM 7,5 MELOXICAM 7,5 37/3.1/0267 ZYDUS HEALTHCARE SA (PTY) 37/3.1/0268 ZYDUS HEALTHCARE SA (PTY) ZYDUS-MELOXICAM 7,5 ZYDUS-MELOXICAM 15 MELOXICAM 7,5 MELOXICAM 15,0 37/3.1/0269 UNICHEM SA (PTY) M-CAM 15 MELOXICAM 15,0 37/21.8.2/0297 NOVO NORDISK (PTY) NOVOFEM EACH WHITE TABLET ESTRADIOL HEMIHYDRATE ESTRADIOL 1,0 NORETHISTERONE ACETATE 1,0 EACH RED TABLET ESTRADIOL HEMIHYDRATE ESTRADIOL 1,0 12.23 Notification of Registration 29 July 2005v2.doc - Feb 2006 Page 3 of 10
37/7.5/0335 PHARMACARE ASPEN SIMVASTATIN 10 SIMVASTATIN 10,0 37/7.5/0336 PHARMACARE ASPEN SIMVASTATIN 20 37/7.5/0337 PHARMACARE ASPEN SIMVASTATIN 40 SIMVASTATIN 20,0 SIMVASTATIN 40,0 37/26/0466 PHARMACHEMIE (PTY) 37/26/0487 KEY ONCOLOGICS (PTY) 37/26/0488 KEY ONCOLOGICS (PTY) 37/21.5.1/0529 ALTANA MADAUS (PTY) 37/21.5.1/0530 ALTANA MADAUS (PTY) 37/21.5.1/0531 ALTANA MADAUS (PTY) EMTHEXATE 2,5 LARACIT 100 LARACIT 500 ALVESCO 40 ALVESCO 80 ALVESCO 160 METHOTREXATE DISODIUM METHOTEXATE 2,5 EACH VIAL CYTARABINE 100,0 EACH VIAL CYTARABINE 500,0 EACH 1,0 ml SOLUTION CICLESONIDE 1,0 EACH 1,0 ml SOLUTION CICLESONIDE 2,0 EACH 1,0 ml SOLUTION CICLESONIDE 4,0 37/2.9/0596 UNICHEM SA (PTY) DOMADOL TRAMADOL HYDROCHLORIDE 50,0 37/1.2/0612 UNICHEM SA (PTY) TRIZAC 20 FLUOXETINE HYDROCHLORIDE FLUOXETINE 20,0 38/1.2/0034 RANBAXY (SA) (PTY) RAN- 10 10,0 38/1.2/0035 RANBAXY (SA) (PTY) SERAN 40 40,0 38/1.2/0036 RANBAXY (SA) (PTY) RAN- 40 40,0 12.23 Notification of Registration 29 July 2005v2.doc - Feb 2006 Page 4 of 10
38/1.2/0037 RANBAXY (SA) (PTY) SERAN 20 20,0 38/1.2/0038 RANBAXY (SA) (PTY) SERAN 10 10,0 38/1.2/0039 RANBAXY (SA) (PTY) RAN- 20 20,0 38/11.4.3/0060 ALTANA MADAUS (PTY) 38/11.4.3/0061 ALTANA MADAUS (PTY) ALTANA- PANTOPRAZOLE 40 ALTANA- PANTOPRAZOLE 20 PANTOPRAZOLE SODIUM SESQUIHYDRATE PANTOPRAZOLE 40,0 PANTOPRAZOLE SODIUM SESQUIHYDRATE PANTOPRAZOLE 20,0 38/5.7.1/0083 PHARMACARE AP LORATADINE SYRUP EACH 5,0 ml SYRUP LORATADINE 5,0 38/5.2/0105 HEXAL PHARMA (SA) (PTY) 38/5.2/0106 HEXAL PHARMA (SA) (PTY) 38/20.1.1/0127 CIPLA MEDPRO (PTY) 38/20.1.1/0133 CIPLA MEDPRO (PTY) 38/21.2/0206 38/21.2/0207 38/3.1/0242 CAMOX (PTY) BISOPROLOL HEXAL 5 BISOPROLOL HEXAL 10 CEFASYN-500 CEFASYN-250 -GLICLAZIDE 40 -GLICLAZIDE 80 APEX-MELOXICAM 7,5 BISOPROLOL FUMARATE 5,0 BISOPROLOL FUMARATE 10,0 CEFUROXIME AXETIL CEFUROXIME 500,0 CEFUROXIME AXETIL CEFUROXIME 250,0 GLICLAZIDE 40,0 GLICLAZIDE 80,0 MELOXICAM 7,5 12.23 Notification of Registration 29 July 2005v2.doc - Feb 2006 Page 5 of 10
38/3.1/0243 CAMOX (PTY) 38/2.9/0274 ADCOCK INGRAM APEX-MELOXICAM 15 MELOXICAM 15 TRAESIC FLASHTABS TRAMADOL HYDROCHLORIDE 50,0 A38/3.1/0383 PHARMACARE ASPEN DICLOFENAC DICLOFENAC 46,5 A38/26/0387 CIPLA MEDPRO (PTY) KEMOSID 100 EACH 5,0 ml SOLUTION ETOPOSIDE 100,0 A38/34/0440 WYETH SOUTH AFRICA (PTY) RAPAMUNE 2 SIROLIMUS 2,0 A38/7.1.3/0470 RANBAXY (SA) (PTY) RAMPREN 10 RAMIPRIL 10,0 A38/7.1.3/0471 RANBAXY (SA) (PTY) RAN-RAMIPRIL 10 CAPSULES RAMIPRIL 10,0 A38/7.5/0477 A38/7.5/0478 A38/7.5/0479 A38/1.2/0487 CIPLA MEDPRO (PTY) -SIMVASTATIN 10 -SIMVASTATIN 20 -SIMVASTATIN 40 CIPLA- 40 SIMVASTATIN 10,0 SIMVASTATIN 20,0 SIMVASTATIN 40,0 40,0 A38/1.2/0490 CIPLA MEDPRO (PTY) DEPRAMIL 40 40,0 A38/3.1/0495 (PTY) MELOXICAM 7,5 MELOXICAM 7,5 A38/3.1/0496 (PTY) MELOXICAM 15 MELOXICAM 15,0 A38/3.1/0497 (PTY) FLEXOCAM 7,5 MELOXICAM 7,5 A38/3.1/0498 (PTY) FLEXOCAM 15 MELOXICAM 15,0 12.23 Notification of Registration 29 July 2005v2.doc - Feb 2006 Page 6 of 10
A38/2.8/0527 PHARMACARE MYBULEN CAPSULES IBUPROFEN 200,0 PARACETAMOL 250,0 CODEINE PHOSPHATE 10,0 A38/1.2/0547 A38/1.2/0548 XIXIA (PTY) XIXIA (PTY) MERCK- 10 MERCK- 20 10,0 20,0 A38/1.2/0549 XIXIA (PTY) MERCK- 40 40,0 A38/7.1.3/0600 ADCOCK INGRAM RILACE 1,25 CAPSULES RAMIPRIL 1,25 A38/7.1.3/0601 ADCOCK INGRAM RILACE 2,5 CAPSULES RAMIPRIL 2,5 A38/7.1.3/0602 ADCOCK INGRAM RILACE 5 CAPSULES RAMIPRIL 5,0 A38/7.1.3/0603 ADCOCK INGRAM RILACE 10 CAPSULES RAMIPRIL 10,0 A38/21.8.2/0615 SERONO SOUTH AFRICA (PTY) CRINONE 8% EACH 1,125 g GEL PROGESTERONE 90,0 A38/5.7.1/0621 A38/20.1.1/0630 A38/20.1.1/0631 A38/20.1.1/0676 BE-TABS (PTY) XIXIA (PTY) XIXIA (PTY) BE-TABS (PTY) LORFAST XIXIA- CLARITHROMYCIN 250 XIXIA- CLARITHROMYCIN 500 BETAROXIME 250 LORATADINE 10,0 CLARITHROMYCIN 250,0 CLARITHROMYCIN 500,0 EACH VIAL CEFUROXIME SODIUM CEFUROXIME 250,0 A38/20.1.1/0677 BE-TABS (PTY) BETAROXIME 750 EACH VIAL CEFUROXIME SODIUM CEFUROXIME 750,0 A38/34/0685 AFRICA (PTY) CERTICAN 0,5 EVEROLIMUS 0,5 12.23 Notification of Registration 29 July 2005v2.doc - Feb 2006 Page 7 of 10
A38/34/0686 AFRICA (PTY) CERTICAN 0,25 EVEROLIMUS 0,25 A38/34/0687 AFRICA (PTY) CERTICAN 0,75 EVEROLIMUS 0,75 A38/34/0688 AFRICA (PTY) CERTICAN 1,0 EVEROLIMUS 1,0 A38/34/0689 AFRICA (PTY) CERTICAN 0,1 DISPERSIBLE TABLET EVEROLIMUS 0,1 A38/34/0690 AFRICA (PTY) CERTICAN 0,25 DISPERSIBLE TABLET EVEROLIMUS 0,25 A38/20.1.1/0694 HEXAL PHARMA (SA) (PTY) CEFU-HEXAL 250 CEFUROXIME AXETIL CEFUROXIME 250,0 A38/20.1.1/0695 HEXAL PHARMA (SA) (PTY) CEFU-HEXAL 500 CEFUROXIME AXETIL CEFUROXIME 500,0 A39/7.1.3/0047 RAN-QUINAPRIL 5 QUINAPRIL 5,0 A39/7.1.3/0048 RAN-QUINAPRIL 10 QUINAPRIL 10,0 A39/7.1.3/0049 RAN-QUINAPRIL 20 QUINAPRIL 20,0 A39/7.1.3/0050 RAN-QUINAPRIL 40 QUINAPRIL 40,0 A39/7.1.3/0051 QUINPREN 5 QUINAPRIL 5,0 A39/7.1.3/0052 QUINPREN 10 QUINAPRIL 10,0 A39/7.1.3/0053 QUINPREN 20 QUINAPRIL 20,0 12.23 Notification of Registration 29 July 2005v2.doc - Feb 2006 Page 8 of 10
A39/7.1.3/0054 QUINPREN 40 QUINAPRIL 40,0 A39/20.1.1/0055 SAFELINE (PTY) CEFTRIAXONE-SAFELINE 1 G EACH VIAL CEFTRIAXONE SODIUM CEFTRIAXONE 1,0 g A39/20.1.1/0056 SAFELINE (PTY) CEFTRIAXONE-SAFELINE 250 EACH VIAL CEFTRIAXONE SODIUM CEFTRIAXONE 250,0 A39/20.1.1/0057 SAFELINE (PTY) CEFTRIAXONE-SAFELINE 500 EACH VIAL CEFTRIAXONE SODIUM CEFTRIAXONE 500,0 A39/1.2/0078 GLAXOSMITHKLINE SOUTH AFRICA (PTY) PAXIL 20 PAROXETINE HYDROCHLORIDE PAROXETINE 20,0 A39/1.2/0238 GLAXOSMITHKLINE SOUTH AFRICA (PTY) PAXIL 30 PAROXETINE HYDROCHLORIDE PAROXETINE 30,0 A39/7.1.3/0239 A39/7.1.3/0240 A39/7.1.3/0241 A39/7.1.3/0242 A39/11.4.3/0322 BE-TABS PHAMACEUTICALS (PTY) -RAMIPRIL 1,25 -RAMIPRIL 2,5 -RAMIPRIL 5 -RAMIPRIL 10 RANIT 150 RAMIPRIL 1,25 RAMIPRIL 2,5 RAMIPRIL 5,0 RAMIPRIL 10,0 RANITIDINE HYDROCHLORIDE RANITIDINE 150,0 A39/11.4.3/0323 BE-TABS PHAMACEUTICALS (PTY) RANIT 300 RANITIDINE HYDROCHLORIDE RANITIDINE 300,0 A39/3.2/0396 CIPLA MEDPRO (PTY) OSTEOBON 70 ALENDRONATE SODIUM ALENDRONIC ACID 70,0 12.23 Notification of Registration 29 July 2005v2.doc - Feb 2006 Page 9 of 10
A39/20.2.8/0446 PHARMACARE ASPEN LAMZID AND EACH PACK NEVIRAPINE COMBIPACK EACH OVAL, WHITE TABLET LAMIVUDINE 150,0 ZIDOVUDINE 300, 0 EACH ROUND, WHITE TABLET NEVIRAPINE 200,0 REGISTRAR OF MEDICINES DR ZOKUFA 12.23 Notification of Registration 29 July 2005v2.doc - Feb 2006 Page 10 of 10