MEDICINES CONTROL COUNCIL

Transcription

1 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) A04/2.1/9 SCHERING-PLOUGH RAPINOVET INJECTION EACH 1,0 ml EMULSION PROPOFOL 10,0 mg 34/7.1.3/0137 MERCK CONCOR 5 PLUS EACH TABLET BISOPROLOL FUMARATE 5,0 mg 12,5 mg 34/7.1.3/0138 MERCK CONCOR 10 PLUS EACH TABLET BISOPROLOL FUMARATE 10,0 mg 25,0 mg 36/7.1.3/0383 NOVARTIS SOUTH AFRICA 37/7.1.3/0327 BIOTECH LABORATORIES 37/7.1.3/0328 BIOTECH LABORATORIES 37/7.1.3/0329 BIOTECH LABORATORIES TAREG 40 BIO-ENALAPRIL MALEATE 5 mg BIO-ENALAPRIL MALEATE 10 mg BIO-ENALAPRIL MALEATE 20 mg EACH TABLET VALSARTAN 40,0 mg EACH TABLET 5,0 mg EACH TABLET 10,0 mg EACH TABLET 20,0 mg 37/7.1.4/0339 COMPUPHARM IMOTRATE 60 mg SR EACH TABLET ISOSORBIDE-5- MONONITRATE 60,0 mg Notification of Oct06v1.doc Nov 2006 Page 1 of 6

2 Notification of of Medicines 37/7.1.4/0340 COMPUPHARM VALPHARMA ISOSORBIDE-5- MONONITRATE 60 mg SR EACH TABLET ISOSORBIDE-5- MONONITRATE 60,0 mg 37/7.1/0378 SANDOZ OROVASC 5 EACH TABLET AMLODIPINE MALEATE AMLODIPINE 5,0 mg 37/7.1/0379 SANDOZ OROVASC 10 EACH TABLET AMLODIPINE MALEATE AMLODIPINE 10,0 mg 38/7.5/0225 PHARMACARE LIMITED BEZACHOLE EACH TABLET BEZAFIBRATE 200,0 mg A38/7.1.3/0392 A38/7.1.3/0393 QUINAZIDE 10/12,5 QUINAZIDE 20/12,5 A38/1.2/0482 PHARMACARE LIMITED ASPEN SERTRALINE 50 mg A38/1.2/0483 PHARMACARE LIMITED ASPEN SERTRALINE 100 mg A38/21.2/0560 GULF DRUG COMPANY ALEMBIC GLICLAZIDE 80 EACH TABLET QUINAPRIL QUINAPRIL 10,0 mg 12,5 mg EACH TABLET QUINAPRIL QUINAPRIL 20,0 mg 12,5 mg EACH TABLET SERTRALINE SERTRALINE 50,0 mg EACH TABLET SERTRALINE SERTRALINE 100,0 mg EACH TABLET GLICLAZIDE 80,0 mg A38/7.1.3/0639 PHARMACARE LIMITED PHARMAPRESS 2,5 mg EACH TABLET 2,5 mg A38/7.1.3/0640 PHARMACARE LIMITED PHARMAPRESS 5 mg EACH TABLET 5,0 mg A38/30.1/0717 AVENTIS PHARMA (PTY) IMOVAX POLIO EACH 0,5 ml DOSE POLIO VIRUS TYPE1 (MAHONEY) 40,0 ANTIGEN D UNITS POLIO VIRUS TYPE 2 (MEF- 1) 8,0 ANTIGEN D UNITS Notification of Oct06v1.doc Nov 2006 Page 2 of 6

3 Notification of of Medicines A39/21.12/0258 A39/21.12/0259 A39/24/0312 A39/34/0313 A39/20.1.1/0334 A39/20.1.1/0335 A39/20.1.1/0336 SAFELINE PHARMACEUTICALS SAFELINE PHARMACEUTICALS SAFELINE PHARMACEUTICALS FINAHEXAL 5 FINASTERIDE HEXAL 5 0,9 % w/v SODIUM CHLORIDE INJECTION B BRAUN WATER FOR INJECTIONS B BRAUN CIPROFLOXACIN- SAFELINE 100 CIPROFLOXACIN- SAFELINE 200 CIPROFLOXACIN- SAFELINE 400 A39/21.10/0357 FERRING MENOPUR POWDER FOR SOLUTION FOR INJECTION A39/8.2/0375 A39/8.2/0376 A39/8.2/0377 A39/8.2/0378 ENOXAPARIN-HEXAL 40 PRE-FILLED SYRINGE ENOXAPARIN-HEXAL 60 PRE-FILLED SYRINGE ENOXAPARIN-HEXAL 80 PRE-FILLED SYRINGE ENOXAPARIN-HEXAL 100 PRE-FILLED SYRINGE POLIO VIRUS TYPE 3 (SAUKETT) 32,0 ANTIGEN D UNITS EACH TABLET FINASTERIDE 5,0 mg EACH TABLET FINASTERIDE 5,0 mg EACH 100,0 ml SOLUTION SODIUM CHLORIDE 0,9 g WATER FOR INJECTIONS 1,0 ml CIPROFLOXACIN LACTATE CIPROFLOXACIN 2,0 mg CIPROFLOXACIN LACTATE CIPROFLOXACIN 2,0 mg CIPROFLOXACIN LACTATE CIPROFLOXACIN 2,0 mg EACH VIAL MENOTROPHIN FOLLICLE STIMULATING HORMONE 75,0 I.U. LUTEINISING HORMONE 75,0 I.U. EACH 0,4 ml SOLUTION 40,0 mg EACH 0,6 ml SOLUTION 60,0 mg EACH 0,8 ml SOLUTION 80,0 mg 100,0 mg Notification of Oct06v1.doc Nov 2006 Page 3 of 6

4 Notification of of Medicines A39/8.2/0379 A39/8.2/0380 ENOXAPARIN-HEXAL 40 AMPOULES ENOXAPARIN-HEXAL 300 MULTI-DOSE VIAL A39/5.7.1/0395 PHARMACARE LIMITED ALLERCHLOR 2 mg/5 ml LIQUID A39/34/0412 FERRING MENOPUR SOLVENT FOR SOLUTION FOR INJECTION A39/4/0436 A39/4/0437 A39/2.7/0440 A39/7.1.3/0531 A39/20.2.2/0617 ZYDUS HEALTHCARE S.A. ABBOTT LABORATORIES S.A. JANSSEN PHARMACEUTICA (PTY) B BRAUN 1 % 5 ml B BRAUN 2 % 5 ml ZYDUS-PARACETAMOL 500 mg TABLETS MAVIK 4 mg TRISPORAL EACH 0,4 ml SOLUTION 40,0 mg EACH 3,0 ml SOLUTION 300,0 mg EACH 5,0 ml LIQUID CHLORPHENAMINE MALEATE 2,0 mg EACH AMPOULE WATER FOR INJECTIONS 1,0 ml 10,0 mg 20,0 mg EACH TABLET PARACETAMOL 500,0 mg EACH CAPSULE TRANDOLAPRIL 4,0 mg EACH CAPSULE ITRACONAZOLE 100,0 mg A40/28/0001 SCHERING PRIMOVIST 5 ml GADOXETIC ACID 181,43 mg A40/28/0002 SCHERING PRIMOVIST 7,5 ml GADOXETIC ACID 181,43 mg A40/28/0003 SCHERING PRIMOVIST 10 ml GADOXETIC ACID 181,43 mg A40/2.5/0158 PHARMAPLAN EPLEPTIN 100 mg EACH CAPSULE GABAPENTIN 100,0 mg A40/2.5/0159 PHARMAPLAN EPLEPTIN 300 mg EACH CAPSULE GABAPENTIN 300,0 mg A40/2.5/0160 PHARMAPLAN EPLEPTIN 400 mg EACH CAPSULE GABAPENTIN 400,0 mg A40/20.1.1/0212 SANDOZ SANDOZ CEFUROXIME 125 mg/5 ml EACH 5,0 ml SUSPENSION CEFUROXIME AXETIL CEFUROXIME 125,0 mg Notification of Oct06v1.doc Nov 2006 Page 4 of 6

5 Notification of of Medicines A40/7.1/0283 A40/21.12/0304 A40/21.12/0305 A40/20.1.2/0331 A40/20.1.2/0332 A40/7.5/0397 A40/7.5/0398 t/a INDO PHARMA CIPLA-MEDPRO (PTY) CIPLA LIFE SCIENCES t/a INDO PHARMA t/a INDO PHARMA CIPLA LIFE SCIENCES CIPLA LIFE SCIENCES KLODIP-5 BICADEX CIPLA-BICALUTAMIDE AMYN 250 AMYN 500 CIPLA-SIMVASTATIN 10 CIPLA-SIMVASTATIN 20 EACH TABLET AMLODIPINE BESYLATE AMLODIPINE 5,0 mg EACH TABLET BICALUTAMIDE 50,0 mg EACH TABLET BICALUTAMIDE 50,0 mg EACH CAPSULE AMOXYCILLIN TRIHYDRATE AMOXYCILLIN 250,0 mg EACH CAPSULE AMOXYCILLIN TRIHYDRATE AMOXYCILLIN 500,0 mg EACH TABLET SIMVASTATIN 10,0 mg EACH TABLET SIMVASTATIN 20,0 mg A40/26/0416 SCHERING MABCAMPATH 30 mg/ml ALEMTUZUMAB 30,0 mg A40/20.1.1/0525 SANDOZ SANDOZ LEVOFLOXACIN 250 A40/20.1.1/0526 SANDOZ SANDOZ LEVOFLOXACIN 500 A40/20.2.8/0531 A40/20.2.8/0532 A40/20.1.2/0563 AUROBINDO PHARMA AUROBINDO PHARMA t/a INDO PHARMA 41/4/ /4/0064 AURO-STAVUDINE CAPSULES 30 mg AURO-STAVUDINE CAPSULES 40 mg AMYN S 250 B BRAUN 1 % 10 ml B BRAUN 1 % 20 ml EACH TABLET LEVOFLOXACIN HEMIHYDRATE LEVOFLOXACIN 250,0 mg EACH TABLET LEVOFLOXACIN HEMIHYDRATE LEVOFLOXACIN 500,0 mg EACH CAPSULE STAVUDINE 30,0 mg EACH CAPSULE STAVUDINE 40,0 mg EACH 5,0 ml SUSPENSION AMOXYCILLIN TRIHYDRATE AMOXYCILLIN 250,0 mg 10,0 mg 10,0 mg Notification of Oct06v1.doc Nov 2006 Page 5 of 6

6 Notification of of Medicines 41/4/ /4/0066 B BRAUN 2 % 10 ml B BRAUN 2 % 20 ml 20,0 mg 20,0 mg REGISTRAR OF MEDICINES MS MANDISA HELA Notification of Oct06v1.doc Nov 2006 Page 6 of 6