MEDICINES CONTROL COUNCIL NOTIFICATION OF REGISTRATION OF MEDICINES BY THE REGISTRAR IN TERMS OF SECTION 17 OF THE MEDICINES AND RELATED SUBSTANCES CONTROL ACT 101 OF 1965 Application Number Holder of registration of Certificate Proprietary Name Active Compound 36/20.1.2/0211 ADCOCK INGRAM 36/11.2/0327 ADCOCK INGRAM 35/15.4/0281 ADCOCK INGRAM ADCO-AMOCLAV BD SCOPEX SYRUP RESCULA AMOXYCILLIN 875,0 CLAVULANIC ACID 125,0 EACH 5,0 ML SYRUP HYOSCINE BUTYLBROMIDE 5,0 EACH 1,0 ML DROPS UNOPROSTONE ISOPROPYLATE 1,5 36/5.7.1/0368 ADCOCK INGRAM ADCO-CETIRIZINE 10 CETIRIZINE DIHYDROCHLORIDE 10,0 12.13 Notification of Registration May04 v1.doc Jul2004 Page 1 of 5
36/5.7.1/0368 ADCOCK INGRAM ADCO-CETIRIZINE 10 CETIRIZINE DIHYDROCHLORIDE 10,0 36/3.1/0402 AUSTELL LABORATORIES (PTY) 36/3.1/0403 AUSTELL LABORATORIES (PTY) 36/20.2.3/0018 AVENTIS PHARMA (PTY) AUSTELL-IBUPROFEN TABLETS 200 AUSTELL-IBUPROFEN TABLETS 400 RIFATER JUNIOR DISPERSIBLE TABLETS IBUPROFEN 200,0 IBUPROFEN 400,0 RIFAMPICIN 60,0 mg ISONIAZID PYRAZINAMIDE 30,0 mg 150,0 mg 36/30.1/0128 AVENTIS PHARMA (PTY) 36/34/0100 B BRAUN MEDICAL (PTY) 34/24/0371 DANENE PHARMACEUTICALS 36/20.1.2/0366 GLAXOSMITHKLINE SOUTH AFRICA (PTY) DIFTAVAX SOL-CART B EUROMED LACTATED RINGER S SOLUTION AUGMENTIN SR EACH DOSE PURIFIED DIPHTERIA TOXOID PURIFIED TETANUS TOXOID EACH CATRIDGE SODIUM BICARBONATE 650,0 G EACH 100,0 ml SOLUTION SODIUM CHLORIDE 600,0 mg SODIUM LACTATE ANHYDROUS 310,0 mg POTASSIUM ACETATE 30,2 mg CALCIUM CHLORIDE DIHYDRATE 20,0 mg EACH 5,0 ML SUSPENSION AMOXYCILLIN 200,0 CLAVULANIC ACID 28,5 12.13 Notification of Registration May04 v1.doc Jul2004 Page 2 of 5
36/2.5/0407 GLAXOSMITHKLINE SOUTH AFRICA (PTY) 36/1.2/0318 H.LUNDBECK 36/1.2/0319 H.LUNDBECK 36/1.2/0320 H.LUNDBECK 36/1.2/0321 H.LUNDBECK 37/1.2/0322 JANSSENPHARMACEUTI CA 37/1.2/0323 JANSSENPHARMACEUTI CA LAMICTIN P2 CIPRALEX 5 CIPRALEX 10 CIPRALEX 15 CIPRALEX 20 CONCERTA 18 CONCERTA 36 LAMOTRIGINE 2,0 ESCITALOPRAM 5,0 ESCITALOPRAM 10,0 ESCITALOPRAM 15,0 ESCITALOPRAM 20,0 HYCHLORIDE 18,0 HYCHLORIDE 36,0 37/1.2/0324 JANSSENPHARMACEUTI CA CONCERTA 54 HYCHLORIDE 54,0 37/20.1.1/0424 MSD INVANZ EACH VIAL ERTAPENEM SODIUM ERTAPENEM 1,0 G 37/21.8.1/0493 NOVARTIS ESTRADOT 25 OESTRADIOL HEMIHYDRATE EQUIVALENT OESTRADIOL 0,39 UG 36/3.2/0473 NOVARTIS OSTEO-CAL 200 IU EACH METERED DOSE SALMON CALCITONIN 200,0 iu 35/11/0186 NOVARTIS XAVENA TEGARSEROD 6,0 37/20.2.2/0369 PHARMACARE ASPEN FLUCONAZOLE 50 EACH CAPSULE FLUCONAZOLE 50,0 37/20.2.2/0370 PHARMACARE ASPEN FLUCONAZOLE 100,0 EACH CAPSULE FLUCONAZOLE 100,0 37/20.2.2/0371 PHARMACARE ASPEN EACH CAPSULE 12.13 Notification of Registration May04 v1.doc Jul2004 Page 3 of 5
FLUCONAZOLE 150,0 FLUCONAZOLE 150,0 37/20.2.2/0372 PHARMACARE ASPEN EACH CAPSULE FLUCONAZOLE 200,0 FLUCONAZOLE 200,0 36/7.5/0370 RANBAXY (SA) SIMVOR 10 TABLETS SIMVASTATIN 10,0 mg 36/7.5/0371 RANBAXY (SA) SIMVOR 20 TABLETS SIMVASTATIN 20,0 mg 36/7.5/0372 RANBAXY (SA) SIMVOR 40 TABLETS SIMVASTATIN 40,0 mg 36/7.5/0373 RANBAXY (SA) SIMVOTIN 10 TABLETS SIMVASTATIN 10,0 mg 36/7.5/0374 RANBAXY (SA) SIMVOTIN 20 TABLETS SIMVASTATIN 20,0 mg 36/7.5/0375 RANBAXY (SA) SIMVOTIN 40 TABLETS SIMVASTATIN 40,0 mg 35/2.6.5/0087 ROLAB (PTY) ENDEPEX EACH CAPSULE SULPIRIDE 50,0 36/20.1.2/0180 SANDOZ (PTY) SANDOZ CO- AMOXYCLAV 1000 AMOXYCILLIN 875,0 CLAVULANIC ACID 125,0 37/21.8.2/0451 SCHERING ANGELIQ OESTRADIOL HEMIHYDRATE OESTRADIOL 1,0 DROSPIRENONE 2,0 35/28/0360 SCHERING RESOVIST 0,9 ML EACH 1,0 ml SOLUTION FERUCARBOTRAN 540,0 35/28/0361 SCHERING RESOVIST 1,4 ML EACH 1,0 ml SOLUTION FERUCARBOTRAN 540,0 35/28/0362 SCHERING RESOVIST 1,6 ML EACH 1,0 ml SOLUTION FERUCARBOTRAN 540,0 36/5.7.1/0425 UCB (S.A) XYZAL LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 37/21.8/0397 WYETH SOUTH AFRICA TOTELLE TRIMEGESTONE 0,125 17B-OESTRADIOL TO 17B-OESTRADIOL 1,0 12.13 Notification of Registration May04 v1.doc Jul2004 Page 4 of 5
37/21.8/0398 WYETH SOUTH AFRICA TOTELLE CYCLE LD TRIMEGESTONE 0,250 17B-OESTRADIOL TO 17B-OESTRADIOL 1,0 EACH PINK TABLET 17B-OESTRADIOL TO 17B-OESTRADIOL 1,0 REGISTRAR OF MEDICINES MS M.P. MATSOSO 12.13 Notification of Registration May04 v1.doc Jul2004 Page 5 of 5