MEDICINES CONTROL COUNCIL

Transcription

1 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) 30/2.10/0392 TEVA TEVA BACLOFEN 10 38/10.1/0002 ADOCK INGRAM STEARNS COUGH SYRUP - PINE TAR AND HONEY FLAVOUR A38/8/0375 A38/1.2/0394 A38/1.2/0398 A38/2.5/0458 A38/2.5/0459 A38/2.5/0460 A38/2.5/0461 PHARMACHEMIE (PTY) PCH ACETYLSALICYLIC ACID CARDIO 80 HEXALOFT 50 HEXAL BACLOFEN 10,0 mg EACH 5,0 ml SYRUP GUAIPHENESIN 100,0 mg ACETYLSALICYLIC ACID 80,0 mg 50,0 mg 50,0 mg LAMOTRIGINE 25,0 mg LAMOTRIGINE 50,0 mg LAMOTRIGINE 100,0 mg LAMOTRIGINE 200,0 mg Notification of Oct08 v1.doc Nov 2008 Page 1 of 6

2 A39/33/0320 BIOPLUS SYRUP STRAWBERRY EACH 30,0 ml SYRUP CALCIUM GLUCONATE 900,0 mg CAFFEINE 270,0 mg CALCIUM CITRATE 180,0 mg THIAMINE 16,0 mg RIBOFLAVIN 11,0 mg PYRIDOXINE 9,0 mg NICOTINAMIDE 42,0 mg D-PANTOTHENOL 11,0 mg CYANOCOBALAMIN 26,0 µg A39/20.1.1/0381 AZITHROHEXAL 500 mg TABLETS AZITHROMYCIN DIHYDRATE AZITHROMYCIN 500,0 mg A39/20.1.1/0534 ZYDUS HEALTHCARE SA MYCOREST 150 EACH CAPSULE FLUCONAZOLE 150,0 mg A39/7.1/0537 AMLODIPINE HEXAL 10 AMLODIPINE 10,0 mg A39/7.1/0539 VASCULEX 10 AMLODIPINE 10,0 mg A39/26/0648 ELIGARD 7,5 mg LEUPROLIDE 7,5 mg A39/26/0649 ELIGARD 22,5 mg LEUPROLIDE 22,5 mg A39/26/0650 ELIGARD 30,0 mg LEUPROLIDE 30,0 mg A39/26/0651 ELIGARD 45,0 mg LEUPROLIDE 45,0 mg A40/3.4/0089 FRESENIUS KABI SOUTH AFRICA STRUCKTOKABIVEN EACH 1 000,0 ml SOLUTION GLUCOSE MONOHYDRATE GLUCOSE 420,0 g L-ALANINE 14,0 g L-ARGININE 12,0 g GLYCINE 11,0 g L-HISTIDINE 3,0 g L-ISOLEUCINE 5,0 g L-LEUCINE 7,4 g L-LYSINE 6,6 g L-METHIONINE 4,3 g L-PHENYLALANINE 5,1 g L-PROLINE 11,2 g L-SERINE 6,5 g TAURINE 1,0 g L-THREONINE4,4 g Notification of Oct08 v1.doc Nov 2008 Page 2 of 6

3 L-TRYPTOPHAN 2,0 g L-TYROSINE 0,4 g L-VALINE 6,2 g CALCIUM CHLORIDE 0,56 g SODIUM GLYCEROPHOSPHATE 4,18 g MAGNESIUM SULPHATE 1,2 g POTASSIUM CHLORIDE 4,48 g SODIUM ACETATE 3,4 g ZINC SULPHATE 1,0129 g PURIFIED STRUCTURED TRIGLYCERIDES 200,0 g A40/34/0090 FRESENIUS KABI SOUTH AFRICA STRUCKTOKABIVEN EF EACH 1 000,0 ml SOLUTION GLUCOSE MONOHYDRATE GLUCOSE 420,0 g L-ALANINE 14,0 g L-ARGININE 12,0 g GLYCINE 11,0 g L-HISTIDINE 3,0 g L-ISOLEUCINE 5,0 g L-LEUCINE 7,4 g L-LYSINE 6,6 g L-METHIONINE 4,3 g L-PHENYLALANINE 5,1 g L-PROLINE 11,2 g L-SERINE 6,5 g TAURINE 1,0 g L-THREONINE 4,4 g L-TRYPTOPHAN 2,0 g L-TYROSINE 0,4 g L-VALINE 6,2 g PURIFIED STRUCTURED TRIGLYCERIDES 200,0 g A40/30.1/0180 GLAXOSMITHKLINE POLIORIX EACH 0,5 ml DOSE POLIO VIRUS TYPE 1 (MAHONEY STRAIN) 40,0 D ANTIGEN UNITS POLIO VIRUS TYPE 2 (MEF-1 STRAIN) 8,0 D ANTIGEN UNITS POLIO VIRUS TYPE 3 (SAUKETT STRAIN) 32,0 ANTIGEN UNITS A40/2.2/0441 SANOFI-SYNTHELABO STILNOX MR 12,5 ZOLPIDEM TARTRATE A40/2.2/0443 SANOFI-SYNTHELABO IVEDAL MR 12,5 ZOLPIDEM TARTRATE Notification of Oct08 v1.doc Nov 2008 Page 3 of 6

4 A40/1.2/0503 ARLOFT 50 50,0 mg A40/1.2/0504 ARLOFT ,0 mg A40/1.2/0505 ARROW 50 50,0 mg A40/1.2/0506 ARROW ,0 mg A40/30.1/0541 AVENTIS PHARMA (PTY) PEDIACEL EACH 0,5 ml DOSE PERTUSSIS TOXOID 20,0 µg FILAMENTOUS HAEMAGGLUTININ 20,0 µg FIMBRIAL AGGLUTINOGENS 2+3 5,0 µg PERTACTIN 3,0 µg DIPHTHERIA TOXOID 5,0 Lf TETANUS TOXOID 5,0 Lf INACTIVATED POLIOMYELITIS VACCINE: TYPE 1 40,0 D-ANTIGEN UNITS TYPE 2 8,0 D-ANTIGEN UNITS TYPE 3 32,0 D-ANTIGEN UNITS HAEMOPHILUS b CONJUGATE VACCINE 10,0 µg BOUND TO TETANUS PROTEIN 20,0 µg A40/2.2/0569 CRITICAL CARE (PTY) SABAX MIDAZOLAM INJECTION 5 mg/5 ml EACH 5,0 ml SOLUTION MIDAZOLAM 5,0 mg A40/202/0570 CRITICAL CARE (PTY) SABAX MIDAZOLAM INJECTION 15 mg/3 ml EACH 3,0 ml SOLUTION MIDAZOLAM 15,0 mg A40/2.2/0571 CRITICAL CARE (PTY) SABAX MIDAZOLAM INJECTION 50 mg/10 ml EACH 10,0 ml SOLUTION MIDAZOLAM 50,0 mg Notification of Oct08 v1.doc Nov 2008 Page 4 of 6

5 41/7.1.3/0176 PHARMA DYNAMICS 41/7.1.3/0177 PHARMA DYNAMICS 41/7.1.3/0178 PHARMA DYNAMICS 41/7.1.3/0179 PHARMA DYNAMICS 41/7.1.3/0212 PHARMA DYNAMICS 41/7.1.3/0213 PHARMA DYNAMICS QUINACE 5 mg QUINACE 10 mg QUINACE 20 mg QUINACE 40 mg QUINACE CO 10/12,5 QUINACE CO 20/12,5 QUINAPRIL QUINAPRIL 5,0 mg QUINAPRIL QUINAPRIL 10,0 mg QUINAPRIL QUINAPRIL 20,0 mg QUINAPRIL QUINAPRIL 40,0 mg QUINAPRIL QUINAPRIL 10,0 mg HYDROCHLOROTHIAZIDE QUINAPRIL QUINAPRIL 20,0 mg HYDROCHLOROTHIAZIDE 41/7.3/0244 PHARMACARE TRIPTAM 50 mg SUMATRIPTAM 50,0 mg 41/7.1.3/0290 NOVARTIS SOUTH AFRICA 41/7.1.3/0291 NOVARTIS SOUTH AFRICA 41/7.1.3/0292 NOVARTIS SOUTH AFRICA 41/34/0558 LEBASI cc 41/20.2.8/ /20.2.8/0597 EXFORGE 5/80 mg EXFORGE 5/160 mg EXFORGE 10/160 mg RENAGEL PROPAN STAVUDINE 20 mg PROPAN STAVUDINE 30 mg AMLODIPINE 5,0 mg VALSARTAN 80,0 mg AMLODIPINE 5,0 mg VALSARTAN 160,0 mg AMLODIPINE 10,0 mg VALSARTAN 160,0 mg SEVELAMER 800,0 mg EACH CAPSULE STAVUDINE 20,0 mg EACH CAPSULE STAVUDINE 30,0 mg Notification of Oct08 v1.doc Nov 2008 Page 5 of 6

6 41/20.2.8/ /21.2/0700 XIXIA 41/21.2/0701 XIXIA 41/21.2/0702 XIXIA PROPAN STAVUDINE 40 mg GLIMARYL 1 mg GLIMARYL 2 mg GLIMARYL 4 mg EACH CAPSULE STAVUDINE 40,0 mg GLIMEPIRIDE 1,0 mg GLIMEPIRIDE 2,0 mg GLIMEPIRIDE 4,0 mg 41/8.1/1086 BAYER KOGENATE FS 250 EACH VIAL OCTOCOG ALFA 250,0 I.U. 41/8.1/1087 BAYER KOGENATE FS 500 EACH VIAL OCTOCOG ALFA 500,0 I.U. 41/8.1/1088 BAYER KOGENATE FS EACH VIAL OCTOCOG ALFA 1 000,0 I.U. 42/6.2/0035 PHARMACARE AMIOTACH EACH 3,0 ml SOLUTION AMIODARONE 150,0 mg 42/5.10/0109 ZYDUS HEALTHCARE SA 42/5.10/0110 ZYDUS HEALTHCARE SA 42/20.2.8/ /20.2.8/0981 VOMIZ 8 mg TABLETS VOMIZ 4 mg TABLETS RENZIR 200 mg ADCO EFAVIRENZ 200 mg ONDANSETRON ONDANSETRON 8,0 mg ONDANSETRON ONDANSETRON 4,0 mg EACH CAPSULE EFAVIRENZ 200,0 mg EACH CAPSULE EFAVIRENZ 200,0 mg T/30.1/0544 MSD PNEUMOVAX 23 EACH 0,5 ml DOSE STREPTOCOCCUS PNEUMONIA 250 µg OF EACH POLYSACHARIDE MS MANDISA HELA REGISTRAR OF MEDICINES Notification of Oct08 v1.doc Nov 2008 Page 6 of 6