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) A04/2.1/11 MERIAL SOUTH AFRICA 32/7.1/0429 33/2.7/0202 PHARMADYNE HEALTHCARE BOMATHAL HEXAL DILTIAZEM HCl 90 PHARMADYNE PARACETAMOL TABLETS EACH 250,0 ml VIAL THIOPENTONE SODIUM THIOPENTONE 5,0 g DILTIAZEM 90,0 mg PARACETAMOL 500,0 mg 35/30.2/0013 MC PHARMA GAMMATET HUMAN IMMUNOGLOBULIN 100,0-170,0 mg 35/30.2/0014 MC PHARMA MATERGAM CONTAIN: HUMAN IMMUNOGLOBULIN 100,0-170,0 mg 37/30.1/0096 AVENTIS PHARMA (PTY) 37/15.4/0691 ALLERGAN STAMARIL MULTIDOSE RELESTAT EACH 0,5 ml DOSE YELLOW FEVER VIRUS STRAIN 17D/AB237 1 000 LD50 EPINASTINE 0,50 mg 12.29 Notification of Aug06v1.doc Sep 2006 Page 1 of 8

Notification of of Medicines 37/26/0692 PHARMACHEMIE (PTY) 38/13.8/0079 GENOP HEALTHCARE 38/1.2/0208 ELI LILLY (S.A.) (PTY) AZATHIOPRINE 50 PCH TRANS-VER-SAL YENTREVE 40 38/24/0212 RESMED HEALTHCARE RESMED ORAL REHYDRATION SALTS B.P. 38/1.2/0228 ELI LILLY (S.A.) (PTY) YENTREVE 20 38/2.7/0296 MDI cc M&P PARACETAMOL TABLETS AZATHIOPRINE 50,0 mg EACH 1,0 g SALICYLIC ACID 150,0 mg EACH CAPSULE DULOXETINE DULOXETINE 40,0 mg EACH SACHET SODIUM CHLORIDE 3,5 g POTASSIUM CHLORIDE 1,5 g SODIUM CITRATE 2,9 g GLUCOSE ANHYDROUS 20,0 g EACH CAPSULE DULOXETINE DULOXETINE 20,0 mg PARACETAMOL 500,0 mg 38/3.2/0310 MDI cc NOVAGESIC PARACETAMOL 320,0 mg CODEINE PHOSPHATE 8,0 mg CAFFEINE 32,0 mg MEPROBAMATE 150,0 mg A38/21.5.1/0341 A38/21.5.1/0342 A38/20.2.8/0378 CIPLA LIFE SCIENCES CIPLA-MEDPRO (PTY) GLAXOSMITHKLINE SOUTH AFRICA (PTY) CIPLA-MOMETASONE NEXONASE TELZIR TABLETS EACH METERED SPRAY DELIVERS: MOMETASONE FUROATE 50,0 µg EACH METERED SPRAY DELIVERS: MOMETASONE FUROATE 50,0 µg FOSAMPRENAVIR CALCIUM FOSAMPRENAVIR 700,0 mg A38/20.2.8/0379 GLAXOSMITHKLINE SOUTH AFRICA (PTY) TELZIR ORAL SUSPENSION EACH 1,0 ml SUSPENSION CONTAIN: FOSAMPRENAVIR CALCIUM FOSAMPRENAVIR 50,0 mg A38/4/0430 3M S.A. UBISTESIN ARTICAINE 40,0 mg ADRENALINE ADRENALINE 0,005 mg 12.29 Notification of Aug06v1.doc Sep 2006 Page 2 of 8

Notification of of Medicines A38/4/0431 3M S.A. UBISTESIN FORTE ARTICAINE 40,0 mg ADRENALINE ADRENALINE 0,01 mg A38/20.1.1/0475 APEX- CLARITHROMYCIN 250 mg TABLETS CLARITHROMYCIN 250,0 mg A38/20.1.1/0476 APEX- CLARITHROMYCIN 500 mg TABLETS CLARITHROMYCIN 500,0 mg A38/4/0546 ABBOTT LABORATORIES S.A. CHIROCANE BAG 1,25 mg/ml EACH 1,0ml SOLUTION LEVOBUPIVACAINE LEVOBUPIVACAINE 1,25 mg A38/21.5.1/0629 INGELHEIM INFLAMMIDE 400 NOVOLIZER EACH METERED DOSE BUDESONIDE 400,0 µg A38/21.2/0648 -METFORMIN 500 mg METFORMIN 500,0 mg A38/21.2/0649 -METFORMIN FORTE 850 mg METFORMIN 850,0 mg A38/7.5/0678 -SIMVASTATIN 10 mg SIMVASTATIN 10,0 mg A38/7.5/0679 -SIMVASTATIN 20 mg SIMVASTATIN 20,0 mg A38/7.5/0680 -SIMVASTATIN 40 mg SIMVASTATIN 40,0 mg A38/20.1.1/0720 CLARITHROMYCIN 250 CLARITHROMYCIN 250,0 mg A38/20.1.1/0721 CLARITHROMYCIN 500 CLARITHROMYCIN 500,0 mg A38/20.1.1/0724 KLARIZON 250 CLARITHROMYCIN 250,0 mg A38/20.1.1/0725 KLARIZON 500 CLARITHROMYCIN 500,0 mg A38/7.1/0728 SOLVAY PHARMA (PTY) TEVETEN PLUS EPROSARTAN MESYLATE EPROSARTAN 600,0 mg HYDROCHLOROTHIAZIDE 12,5 mg 12.29 Notification of Aug06v1.doc Sep 2006 Page 3 of 8

Notification of of Medicines A39/7.5/0031 MSD INEGY 10/10 SIMVASTATIN 10,0 mg EZETIMIBE 10,0 mg A39/7.5/0032 MSD INEGY 10/20 SIMVASTATIN 20,0 mg EZETIMIBE 10,0 mg A39/7.5/0033 MSD INEGY 10/40 SIMVASTATIN 40,0 mg EZETIMIBE 10,0 mg A39/7.5/0034 MSD INEGY 10/80 SIMVASTATIN 80,0 mg EZETIMIBE 10,0 mg A39/20.1.1/0085 A39/20.1.1/0086 A39/20.1.1/0087 A39/7.1.3/0136 A39/7.1.3/0137 BETRIAXON-250 BETRIAXON-500 BETRIAXON-1 000 QUINAHEXAL 5 QUINAHEXAL 10 EACH VIAL CEFTRIAXONE SODIUM CEFTRIAXONE 250,0 mg EACH VIAL CEFTRIAXONE SODIUM CEFTRIAXONE 500,0 mg EACH VIAL CEFTRIAXONE SODIUM CEFTRIAXONE 1 000,0 mg QUINAPRIL QUINAPRIL 5,0 mg QUINAPRIL QUINAPRIL 10,0 mg A39/21.8.2/0161 SANDOZ CLARO 35 CYPROTERONE ACETATE 2,0 mg ETHINYLESTRADIOL 0,035 mg A39/5.8/0196 A39/5.8/0197 A39/1.2/0337 A39/1.2/0338 ADCOCK INGRAM LIMITED ADCOCK INGRAM LIMITED PANADO MEDSIP FOR CHILDREN L.C.C. HOT MEDICATION FOR CHILDREN - CITALOPRAM 10 mg - CITALOPRAM 20 mg EACH SACHET PARACETAMOL 250,0 mg ASCORBIC ACID 20,0 mg EACH SACHET PARACETAMOL 250,0 mg ASCORBIC ACID 20,0 mg CITALOPRAM HYDROBROMIDE CITALOPRAM 10,0 mg CITALOPRAM HYDROBROMIDE CITALOPRAM 20,0 mg 12.29 Notification of Aug06v1.doc Sep 2006 Page 4 of 8

Notification of of Medicines A39/1.2/0339 - CITALOPRAM 40 mg CITALOPRAM HYDROBROMIDE CITALOPRAM 40,0 mg A39/11.2/0353 PHARMACARE LIMITED HYOSPASMOL SYRUP EACH 5,0 ml LIQUID HYOSCINE-N-BUTYL BROMIDE 5,0 mg A39/7.1/0370 A39/7.1/0371 AMLOPRESS 5 mg AMLOPRESS 10 mg AMLODIPINE BESYLATE AMLODIPINE 5,0 mg AMLODIPINE BESYLATE AMLODIPINE 10,0 mg A39/11.5/0385 NORGINE PEGICOL EACH SACHET MACROGOL 3 350 6,563 g SODIUM CHLORIDE 175,4 mg SODIUM BICARBONATE 89,3 mg POTASSIUM CHLORIDE 23,3 mg A39/2.5/0429 A39/2.5/0430 A39/2.5/0431 A39/2.5/0432 A39/2.5/0433 A39/2.5/0434 A39/20.1.2/0488 A39/20.1.2/0489 NEUREXAL 100 mg NEUREXAL 300 mg NEUREXAL 400 mg GABAPENTIN HEXAL 100 GABAPENTIN HEXAL 300 GABAPENTIN HEXAL 400 -CO- AMOXICLAV 375 mg -CO- AMOXICLAV 625 mg EACH CAPSULE GABAPENTIN 100,0 mg EACH CAPSULE GABAPENTIN 300,0 mg EACH CAPSULE GABAPENTIN 400,0 mg EACH CAPSULE GABAPENTIN 100,0 mg EACH CAPSULE GABAPENTIN 300,0 mg EACH CAPSULE GABAPENTIN 400,0 mg AMOXYCILLIN TRIHYDRATE AMOXYCILLIN 250,0 mg POTASSIUM CLAVULANATE CLAVULANIC ACID 125,0 mg AMOXYCILLIN TRIHYDRATE AMOXYCILLIN 500,0 mg POTASSIUM CLAVULANATE CLAVULANIC ACID 125,0 mg 12.29 Notification of Aug06v1.doc Sep 2006 Page 5 of 8

Notification of of Medicines A39/26/0496 A39/26/0497 A39/26/0498 A39/26/0499 A39/1.2/0548 A39/5.10/0581 A39/5.10/0582 A39/1.2/0635 A39/1.2/0636 A39/21.2/0638 A39/21.2/0639 SANOFI-SYNTHELABO SANOFI-SYNTHELABO SANOFI-SYNTHELABO SANOFI-SYNTHELABO ZYDUS HEALTHCARE S.A. ZYDUS HEALTHCARE S.A. MERCK GENERICS RSA MERCK GENERICS RSA ZYDUS HEALTHCARE S.A. ZYDUS HEALTHCARE S.A. ELOXATIN 50 mg/10 ml ELOXATIN 100 mg/20 ml ELOXATIN 50 mg/10 ml RTU ELOXATIN 100 mg/20 ml RTU CILATE VOMIZ 4 mg INJECTION VOMIZ 8 mg INJECTION DANTRIX 50 DANTRIX 100 BIGSENS 500 BIGSENS 850 OXALIPLATIN 5,0 mg OXALIPLATIN 5,0 mg OXALIPLATIN 5,0 mg OXALIPLATIN 5,0 mg CITALOPRAM HYDROBROMIDE CITALOPRAM 20,0 mg EACH AMPOULE ONDANSETRON ONDANSETRON 4,0 mg EACH AMPOULE ONDANSETRON ONDANSETRON 8,0 mg SERTRALINE SERTRALINE 50,0 mg SERTRALINE SERTRALINE 100,0 mg METFORMIN 500,0 mg METFORMIN 850,0 mg A40/7.1/0057 UNICHEM S.A. CORVADIL 5 AMLODIPINE BESYLATE AMLODIPINE 5,0 mg A40/7.1/0058 UNICHEM S.A. CORVADIL 10 AMLODIPINE BESYLATE AMLODIPINE 10,0 mg 12.29 Notification of Aug06v1.doc Sep 2006 Page 6 of 8

Notification of of Medicines A40/21.2/0149 A40/21.2/0150 A40/2.6.5/0204 A40/2.6.5/0205 A40/20.2.8/0244 A40/2.5/0273 A40/2.5/0274 A40/2.5/0275 A40/2.5/0276 A40/7.1/0312 A40/7.1/0313 CIPLA LIFE SCIENCES CIPLA LIFE SCIENCES JANSSEN PHARMACEUTICA (PTY) JANSSEN PHARMACEUTICA (PTY) CIPLA LIFE SCIENCES CIPLA-PIOGLITAZONE 15 CIPLA-PIOGLITAZONE 30 RISPERDAL QUICKLET 3 mg RISPERDAL QUICKLET 4 mg CIPLA DUOVIR - LAMOTRIGINE 25 mg - LAMOTRIGINE 50 mg - LAMOTRIGINE 100 mg - LAMOTRIGINE 200 mg AMLATE 5 AMLATE 10 PIOGLITAZONE PIOGLITAZONE 15,0 mg PIOGLITAZONE PIOGLITAZONE 30,0 mg RISPERIDONE 3,0 mg RISPERIDONE 4,0 mg LAMIVUDINE 150,0 mg ZIDOVUDINE 300,0 mg LAMOTRIGINE 25,0 mg LAMOTRIGINE 50,0 mg LAMOTRIGINE 100,0 mg LAMOTRIGINE 200,0 mg AMLODIPINE MALEATE AMLODIPINE 5,0 mg AMLODIPINE MALEATE AMLODIPINE 10,0 mg A40/20.1.1/0333 SANDOZ BINOZYT 500 AZITHROMYCIN MONOHYDRATE EQUIVALENT TO AZITHROMYCIN 500,0 mg A40/20.1.1/0334 SANDOZ SANDOZ AZITHROMYCIN 500 A40/20.2.2/0343 DERMAX 125 AZITHROMYCIN MONOHYDRATE EQUIVALENT TO AZITHROMYCIN 500,0 mg TERBINAFINE TERBINAFINE 125,0 mg 12.29 Notification of Aug06v1.doc Sep 2006 Page 7 of 8

Notification of of Medicines A40/20.2.2/0344 DERMAX 250 TERBINAFINE TERBINAFINE 250,0 mg A40/1.2/0366 BERON 15 MIRTAZAPINE 15,0 mg A40/1.2/0367 BERON 30 MIRTAZAPINE 30,0 mg A40/20.2.8/0376 AUROBINDO PHARMA AURO-LAMIVUDINE TABLETS 150 mg LAMIVUDINE 150,0 mg A40/20.2.8/0381 AUROBINDO PHARMA AURO-LAMIZIDO LAMIVUDINE 150,0 mg ZIDOVUDINE 300,0 mg A40/20.2.8/0382 AUROBINDO PHARMA AURO-NEVIRAPINE TABLETS 200 mg NEVIRAPINE 200,0 mg A40/20.2.8/0383 AUROBINDO PHARMA AURO-ZIDOVUDINE TABLETS 300 mg ZIDOVUDINE 300,0 mg A40/20.2.2/0401 FINDERM 125 TERBINAFINE TERBINAFINE 125,0 mg A40/20.2.2/0402 FINDERM 250 TERBINAFINE TERBINAFINE 250,0 mg REGISTRAR OF MEDICINES MS MANDISA HELA 12.29 Notification of Aug06v1.doc Sep 2006 Page 8 of 8