MEDICINES CONTROL COUNCIL
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1 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 01/20.1.2/10 NORBROOK LABORATORIES S.A. 02/ /14 SCHERING-PLOUGH 02/21.1/18 INTERVET S.A. (PTY) 02/21.1/19 INTERVET S.A. (PTY) 02/21.1/20 INTERVET S.A. (PTY) 03/21.1/6 NORBROOK LABORATORIES S.A. LINCOJECT INJECTION CEPOREX 50 MG CEFA-VET 50 MG CEFA-VET 200 MG CEFA-VET 1000 MG NOROCLAV INJECTION EACH VIAL LINCOMYCIN LINCOMYCIN 100,0 CEPHALEXIN MONOHYDRATE CEPHALEXIN 50,0 CEFADROXIL 50,0 CEFADROXIL 200,0 CEFADROXIL 1000,0 EACH 1,0 ml SUSPENSION AMOXYCILLIN TRIHYDRATE AMOXYCILLIN 140,0 POTASSIUM CLAVULANATE CLAVULANIC ACID Notification of Registration 23 Sept 2005v2.doc Feb 2006 Page 1 of 13
2 03/3.1/7 INTERVET S.A. (PTY) A03/21.1/11 PHARMACIA S.A. (PTY) A03/3.1.2/14 MERIAL SOUTH AFRICA A03/3.1.2/15 MERIAL SOUTH AFRICA 32/2.8/0320 GROUP LABORATORIES S.A. 32/34/0423 ELI LILLY (S.A.) (PTY) 33/21.12/0517 HEXAL PHARMA (SA) 33/21.12/0518 HEXAL PHARMA (SA) 34/7.1/0284 HEXAL PHARMA (SA) 34/7.1/0285 HEXAL PHARMA (SA) 34/7.1/0286 HEXAL PHARMA (SA) 34/24/0369 LEBASI CC 35/2.2/0321 HEXAL PHARMA (SA) 35/2.2/0322 HEXAL PHARMA (SA) QUADRISOL 1 GEL EACH 1,0 ml GEL VEDAPROFEN 1,0 EXCENEL RTU EACH 1,0 ml SUSPENSION SUSPENSION FOR INJECTION CEFTIOFUR CEFTIOFUR 50,0 PREVICOX 57 MG CHEWABLE TABLET FIROCOXIB 57.0 PREVICOX 227 MG CHEWABLE TABLET FIROCOXIB GRAND-PA HEADACHE EACH POWDER POWDERS LEMON ASPIRIN 453,6 FLAVOUR PARACETAMOL 324,0 CAFFEINE 64,8 OVANTA RALOXIFENE 60,0 TAMOXIHEXAL 10 TAMOXIFEN CITRATE TAMOXIFEN 10,0 TAMOXIHEXAL 20 TAMOXIFEN CITRATE TAMOXIFEN 20,0 CARDOSIN 1 DOXAZOSIN MESYLATE DOXAZOSIN 1,0 CARDOSIN 2 DOXAZOSIN MESYLATE DOXAZOSIN 2,0 CARDOSIN 4 DOXAZOSIN MESYLATE EUROMED DEXTROSE 50% SOLUTION MIDAZOLAM-HEXAL 5 MG/ML MIDAZOLAM-HEXAL 15 MG/3 ML DOXAZOSIN 4,0 EACH 1,0 ml SOLUTION DEXTROSE MONOHYDRATE 500,0 EACH 1,0 ml AMPOULE MIDAZOLAM MIDAZOLAM 5,0 EACH 3,0 ml AMPOULE MIDAZOLAM MIDAZOLAM 15, Notification of Registration 23 Sept 2005v2.doc Feb 2006 Page 2 of 13
3 36/20.1.1/0222 BE-TABS 36/15.4/0357 ADCOCK INGRAM LIMITED ERYKO-250 SPERSALLERG SDU (SINGLE DOSE UNIT) ERYTHROMYCIN STEARATE ERYTHROMYCIN 250,0 EACH 0,3 ml SOLUTION ANTAZOLINE 0,15 TETRYZOLINE 0,12 36/17.1/0431 MC PHARMA MUSCURON EACH AMPOULE VECURONIUM BROMIDE 4,0 36/10.2.1/0443 ADCOCK INGRAM LIMITED 37/20.1.2/0003 AUSTELL 37/20.1.2/0004 AUSTELL FORAMET DRY POWDER AUSTELL-AMOXICILLIN 250 MG AUSTELL-AMOXICILLIN 500 MG EACH CAPSULE FORMOTEROL FUMARATE 0,012 EACH CAPSULE AMOXICILLIN TRIHYDRATE AMOXICILLIN 250,0 EACH CAPSULE AMOXICILLIN TRIHYDRATE AMOXICILLIN 500,0 37/1.2/0083 MC PHARMA FLUTINOL EACH CAPSULE FLUOXETINE FLUOXETINE 20,0 37/34/0088 B.BRAUN MEDICAL (PTY) 37/34/0089 B.BRAUN MEDICAL (PTY) 37/1.2/0156 CIPLA LIFE SCIENCES ACIDIC BICARBONATE HAEMODIALYSIS CONCENTRATE SW 95A ALKALINE BICARBONATE HAEMODIALYSIS CONCENTRATE 8,4% SOLUTION NUZAK ORAL SOLUTION 37/20.1.1/0222 PHARMACARE LIMITED AP AZITHROMYCIN 500 MG EACH 100,0 ml SOLUTION SODIUM CHLORIDE 210,68 g POTASSIUM CHLORIDE 5,22 g CALCIUM CHLORIDE 9,01 g MAGNESIUM CHLORIDE HEXAHYDRATE 3,56 g GLACIAL ACETIC ACID 6,31 g EACH 100,0 ml SOLUTION SODIUM BICARBONATE 84,0 g EACH 5,0 ml SOLUTION FLUOXETINE FLUOXETINE 20,0 AZITHROMYCIN MONOHYDRATE EQUIVALENT TO AZITHROMYCIN 500,0 37/7.1/0230 PHARMAPLAN DILEM 30 MG DILTIAZEM 30, Notification of Registration 23 Sept 2005v2.doc Feb 2006 Page 3 of 13
4 37/7.1/0231 PHARMAPLAN DILEM 60 MG DILTIAZEM 60,0 37/26/0256 PHARMACHEMIE (PTY) VINCRISTINE RTU 1 EACH 1,0 ml SOLUTION VINCRISTINE SULPHATE 1,0 37/26/0257 PHARMACHEMIE (PTY) VINCRISTINE RTU 2 EACH 2,0 ml SOLUTION VINCRISTINE SULPHATE 2,0 37/18.1/0291 PHARMAPLAN DIFROSID 37/21.2/0407 GULF DRUG COMPANY 37/21.10/0408 FERRING 37/34/0409 FERRING 37/18.1/0432 AUSTELL 37/18.1/0433 AUSTELL 37/16.4/0435 ADCOCK INGRAM LIMITED 37/25.2/0501 ADCOCK INGRAM CRITICAL CARE (PTY) DIABETMIN 850 GONAPEPTYL DEPOT POWDER FOR INJECTION GONAPEPTYL DEPOT INJECTION VEHICLE AUSTELL-FUROSEMIDE 20 MG AUSTELL-FUROSEMIDE 40 MG L.C.C. THROAT LOZENGES MENTHOL OLICLINOMEL N4-550 E FUROSEMIDE 40,0 850,0 EACH VIAL TRIPTORELIN 3,75 EACH 1,0 ml SUSPENSION DEXTRAN 104,0 WATER FOR INJECTION to 1,0 ml FUROSEMIDE 20,0 FUROSEMIDE 40,0 EACH LOZENGE CETYLPYRIDINIUM CHLORIDE 1,47 BENZYL ALCOHOL 6,5 EACH BAG 5,5% AMINO ACIDS SOLUTION compartment with electrolytes containing per 1,0 litre: L-alanine 11,39 g L-arginine 6.33 g Glycine 5,67 g L-histidine 2,64 g L-isoleucine 3.30 g L-leucine 4,02 g L-lysine 3,19 g L-methionine 2,20 g L-phenylalanine 3,08 g L-proline 3,74 g L-serine 2,75 g L-threonine 2,31 g L-tryptophan 0,99 g L-tyrosine 0,22 g L-valine 3,19 g Sodium acetate 2,45 g Sodium glycerophosphate 5,36 g Potassium chloride 2,98 g Magnesium chloride 1,12 g 20% GLUCOSE SOLUTION compartment with electrolyte Notification of Registration 23 Sept 2005v2.doc Feb 2006 Page 4 of 13
5 37/25.2/0502 ADCOCK INGRAM CRITICAL CARE (PTY) 37/25.2/0503 ADCOCK INGRAM CRITICAL CARE (PTY) calcium containing per 1,0 litre Glucose monohydrate equivalent to Glucose 200,00 g Calcium chloride 0,74 g 10% LIPID EMULSION compartment containing per 1,0 litre Refined soya-bean oil + Refined olive oil 100,00 g OLICLINOMEL N5-800 E EACH BAG 7% AMINO ACIDS SOLUTION compartment with electrolytes containing per 1,0 litre: L-alanine 14,49 g L-arginine 8,05 g Glycine 7,21 g L-histidine 3,36 g L-isoleucine 4,20 g L-leucine 5,11 g L-lysine 4.06 g L-methionine 2,80 g L-phenylalanine 3,92 g L-proline 4,76 g L-serine 3,50 g L-threonine 2,94 g L-tryptophan 1,26 g L-tyrosine 0,28 g L-valine 4,06 g Sodium acetate 6,12 g Sodium glycerophosphate 5,36 g Potassium chloride 4,47 g Magnesium chloride 1,12 g 25% GLUCOSE SOLUTION compartment with electrolyte calcium containing per 1,0 litre Glucose monohydrate equivalent to Glucose 250,00 g Calcium chloride 0,74 g 20% LIPID EMULSION compartment containing per 1,0 litre Refined soya-bean oil + Refined olive oil 200,00 g OLICLINOMEL N6-900 E EACH BAG 8,5% AMINO ACIDS SOLUTION compartment with electrolytes containing per 1,0 litre: L-alanine 17,60 g L-arginine 9,78 g Glycine 8.76 g L-histidine 4,08 g L-isoleucine 5,10 g L-leucine 6,21 g L-lysine 4.93 g L-methionine 3,40 g L-phenylalanine 4,76 g L-proline 5,78 g Notification of Registration 23 Sept 2005v2.doc Feb 2006 Page 5 of 13
6 37/25.2/0504 ADCOCK INGRAM CRITICAL CARE (PTY) L-serine 4,25 g L-threonine 3,57 g L-tryptophan 1,53 g L-tyrosine 0,34 g L-valine 4,93 g Sodium acetate 6,12 g Sodium glycerophosphate 5,36 g Potassium chloride 4,47 g Magnesium chloride 1,12 g 30% GLUCOSE SOLUTION compartment with electrolyte calcium containing per 1,0 litre Glucose monohydrate equivalent to Glucose 300,00 g Calcium chloride 0,74 g 20% LIPID EMULSION compartment containing per 1,0 litre Refined soya-bean oil + Refined olive oil 200,00 g OLICLINOMEL N E EACH BAG 10% AMINO ACIDS SOLUTION compartment with electrolytes containing per 1,0 litre: L-alanine 20,70 g L-arginine 11,50 g Glycine 10,30 g L-histidine 4,80 g L-isoleucine 6,00 g L-leucine 7,30 g L-lysine 5,80 g L-methionine 4,00 g L-phenylalanine 5,60 g L-proline 6,80 g L-serine 5,00 g L-threonine 4,20 g L-tryptophan 1,80 g L-tyrosine 0,40 g L-valine 5,80 g Sodium acetate 6,12 g Sodium glycerophosphate 5,36 g Potassium chloride 4,47 g Magnesium chloride 1,12 g 40% GLUCOSE SOLUTION compartment with electrolyte calcium containing per 1,0 litre Glucose monohydrate equivalent to Glucose 400,00 g Calcium chloride 0,74 g 20% LIPID EMULSION compartment containing per 1,0 litre Refined soya-bean oil + Refined olive oil 200,00 g 37/2.9/0532 MC PHARMA DOLOTRAM CAPSULES EACH CAPSULE TRAMADOL 50, Notification of Registration 23 Sept 2005v2.doc Feb 2006 Page 6 of 13
7 37/5.8/0556 ADCOCK INGRAM LIMITED 37/20.2.2/0559 ADCOCK INGRAM LIMITED 37/21.2/0570 ARROW PHARMA SOUTH AFRICA (PTY) 37/21.2/0571 ARROW PHARMA SOUTH AFRICA (PTY) 37/20.1.1/0648 SAFELINE 37/21.5.1/0652 CIPLA-MEDPRO (PTY) 37/21.5.1/0653 CIPLA-MEDPRO (PTY) 37/21.5.1/0654 CIPLA-MEDPRO (PTY) 37/20.2.3/0667 WYETH SOUTH AFRICA 38/20.1.2/ /5.10/0045 AUSTELL 38/5.10/0046 AUSTELL 38/1.2/0068 PHARMA DYNAMICS COLCAPS CHILDREN S EACH 5,0 ml SYRUP SYRUP ORANGE FLAVOUR PARACETAMOL 120,0 CODEINE PHOSPHATE 5,0 PSEUDOEPHEDRINE HCL 20,0 ADCO-SPOROZOLE EACH CAPSULE ARROW HCL 500 MG ARROW HCL 850 MG SAFELINE-AMIKACIN SULPHATE 1 G BECLATE 100 HFA BECLATE 200 HFA BECLATE 250 HFA MYRIN-P FORTE APEX-CLAVUTIN 625 MG AUSTELL- ONDANSETRON 4 MG AUSTELL- ONDANSETRON 8 MG SERRAPRESS 30 ITRACONAZOLE 100,0 500,0 850,0 EACH 4,0 ml SOLUTION AMIKACIN SULPHATE 1 000,0 EACH ACTUATION DELIVERS: BECLOMETHASONE DIPROPIONATE ug EACH ACTUATION DELIVERS: BECLOMETHASONE DIPROPIONATE ug EACH ACTUATION DELIVERS: BECLOMETHASONE DIPROPIONATE ug PYRAZINAMIDE 400,0 ETHAMBUTOL 275,0 RIFAMPICIN 150,0 ISONIAZID 75,0 AMOXYCILLIN TRIHYDRATE AMOXYCILLIN 500,0 POTASSIUM CLAVULANATE CLAVULANIC ACID 125,0 ONDANSETRON DIHYDRATE ONDANSETRON 4,0 ONDANSETRON DIHYDRATE ONDANSETRON 8,0 PAROXETINE PAROXETINE 30, Notification of Registration 23 Sept 2005v2.doc Feb 2006 Page 7 of 13
8 38/1.2/0069 PHARMA DYNAMICS 38/1.2/0072 PHARMA DYNAMICS 38/1.2/0074 PHARMA DYNAMICS 38/21.1/0084 NOVO NORDISK (PTY) SERRAPRESS 20 PAROXETINE PAROXETINE 20,0 PHARMA DYNAMICS PAROXETINE 20 PAROXETINE PAROXETINE 20,0 PHARMA DYNAMIC PAROXETINE 30 LEVEMIR PAROXETINE PAROXETINE 30,0 EACH 1,0 ML SOLUTION INSULIN DETEMIR 100,0 units 38/5.7.1/0087 PHARMACARE LIMITED CLARINESE SYRUP EACH 5,0 ml SYRUP LORATADINE 5,0 38/7.5/0123 PHARMACARE LIMITED ASPEN PRAVASTATIN 10 MG 38/7.5/0139 PHARMACARE LIMITED ASPEN PRAVASTATIN 20 MG 38/7.5/0140 PHARMACARE LIMITED ASPEN PRAVASTATIN 40 MG 38/30.1/0182 AVENTIS PHARMA (PTY) 38/21.5.1/0186 CIPLA-MEDPRO (PTY) 38/21.8.2/0248 ADCOCK INGRAM LIMITED 38/34/0263 SCHERING-PLOUGH 38/20.1.2/0266 MENOMUNE BECLATE 50 HFA ADCO-FEM 35 PEG-INTRON 80 MICROGRAM APEX-CLAVUTIN 375 MG PRAVASTATIN SODIUM 10,0 PRAVASTATIN SODIUM 20,0 PRAVASTATIN SODIUM 40,0 EACH 0,5 ml DOSE NEISSERIA MENINGITIDES GROUP A 50,0 ug NEISSERIA MENINGITIDES GROUP C 50,0 ug NEISSERIA MENINGITIDES GROUP Y 50,0 ug NEISSERIA MENINGITIDES GROUP W ,0 ug EACH ACTUATION DELIVERS: BECLOMETHASONE DIPROPIONATE 50,0 ug CYPROTERONE ACETATE 2,0 ETHINYLOESTRADIOL 0,035 EACH VIAL PEGINTERFERON ALFA-2b 80,0 mcg AMOXYCILLIN TRIHYDRATE AMOXYCILLIN 250,0 POTASSIUM CLAVULANATE CLAVULANIC ACID 125, Notification of Registration 23 Sept 2005v2.doc Feb 2006 Page 8 of 13
9 38/7.1/0271 PFIZER LABORATORIES 38/7.1/0272 PFIZER LABORATORIES 38/34/0329 SCHERING-PLOUGH A38/1.2/0403 A38/1.2/0413 A38/8.2/0422 A38/20.1.1/0448 A38/20.1.1/0449 A38/20.1.1/0450 GENERIX INTERNATIONAL SA GENERIX INTERNATIONAL SA CIPLA-MEDPRO (PTY) ISTIN 5 MG AMLODIPINE BESYLATE AMLODIPINE 5,0 ISTIN 10 MG AMLODIPINE BESYLATE AMLODIPINE 10,0 PEG-INTRON 120 EACH VIAL MICROGRAM PEGINTERFERON ALFA-2b 120,0 mcg PROLAX FLUOXETINE FLUOXETINE 20,0 PROLAX CAPSULES EACH CAPSULE FLUOXETINE FLUOXETINE 20,0 CIPLA-WARFARIN 5 MG WARFARIN SODIUM 5,0 APEX-CIPROFLOXACIN 250 MG CIPROFLOXACIN APEX-CIPROFLOXACIN 500 MG APEX-CIPROFLOXACIN 750 MG A38/20.1.1/0467 RESMED HEALTHCARE RESMED CEFUOXIME 750 INJECTION A38/13.4.1/0473 A38/1.2/0474 A38/7.3/0480 PHARMACO DISTRIBUTION GLAXOSMITHKLINE SOUTH AFRICA (PTY) LOCATOP APEX-PAROXETINE 20 MG IMITREX 50 CIPROFLOXACIN 250,0 CIPROFLOXACIN CIPROFLOXACIN 500,0 CIPROFLOXACIN CIPROFLOXACIN 750,0 EACH VIAL CEFOROXIME SODIUM CEFUROXIME 750,0 EACH 100,0 g CREAM DESONIDE 100,0 PAROXETINE PAROXETINE 20,0 SUMATRIPTAN SUCCINATE SUMATRIPTAN 50, Notification of Registration 23 Sept 2005v2.doc Feb 2006 Page 9 of 13
10 A38/7.3/0481 A38/5.2/0501 A38/5.2/0502 A38/5.2/0503 A38/21.2/0504 A38/21.2/0505 A38/26/0532 A38/26/0533 A38/2.7/0561 A38/21.8.2/0563 GLAXOSMITHKLINE SOUTH AFRICA (PTY) AUSTELL AUSTELL AUSTELL AUSTELL AUSTELL CIPLA-MEDPRO (PTY) CIPLA-MEDPRO (PTY) BRISTOL-MYERS SQUIBB NOVARTIS SOUTH AFRICA IMITREX 100 TENOPRESS 25 MG TENOPRESS 50 MG TENOPRESS 100 MG AUSTELL- 500 MG AUSTELL- 850 MG KEMOCARB 150 KEMOCARB 450 PERFALGAN 1 G ESTALIS 25/125 A38/20.1.1/0580 RESMED HEALTHCARE RES-CEFOTAX 500 INJECTION A38/20.1.1/0581 RESMED HEALTHCARE RES-CEFOTAX 1000 INJECTION SUMATRIPTAN SUCCINATE SUMATRIPTAN 100,0 ATENOLOL 25,0 ATENOLOL 50,0 ATENOLOL 100,0 500,0 850,0 EACH VIAL CARBOPLATIN 150,0 EACH VIAL CARBOPLATIN 450,0 EACH 100,0 ml VIAL PARACETAMOL 1,0 g EACH PATCH ESTRADIOL HEMIHYDRATE ESTRADIOL 0,256 NORETHISTERONE ACETATE 2,40 EACH VIAL CEFOTAXIME SODIUM CEFOTAXIME 500,0 EACH VIAL CEFOTAXIME SODIUM CEFOTAXIME 1000,0 A38/20.1.1/0582 RESMED HEALTHCARE REZONE 250 INJECTION EACH VIAL CEFTRIAXONE SODIUM CEFTRIAXONE 250,0 A38/20.1.1/0583 RESMED HEALTHCARE REZONE 500 INJECTION EACH VIAL CEFTRIAXONE SODIUM CEFTRIAXONE 500,0 A38/21.2/0590 A38/21.2/0591 A38/26/0593 AVENTIS PHARMA (PTY) DIAFORMIN 500 MG DIAFORMIN FORTE 850 MG ENDOXAN 50 MG 500,0 850,0 CYCLOPHOSPHAMIDE MONOHYDRATE EQUIVALENT TO CYCLOPHOSPHAMIDE 50, Notification of Registration 23 Sept 2005v2.doc Feb 2006 Page 10 of 13
11 A38/20.1.1/0606 PHARMAPLAN CEFOTAXIME- EACH VIAL COMBINOPARM 1 G CEFOTAXIME SODIUM CEFOTAXIME 1,0 g A38/20.1.1/0607 PHARMAPLAN CEFOTAXIME- COMBINOPARM 500 MG EACH VIAL CEFOTAXIME SODIUM CEFOTAXIME 500,0 A38/5.7.2/0625 MSD EMEND COMBI PACK EACH PACK 1 X OPAQUE CAPSULE CONTAINING: APREPITANT 125,0 2 X WHITE CAPSULES CONTAINING: APREPITANT 80,0 A38/5.7.2/0626 MSD EMEND 80 EACH CAPSULE APREPITANT 80,0 A38/5.7.2/0627 MSD EMEND 125 EACH CAPSULE APREPITANT 125,0 A38/20.1.1/0633 RESMED HEALTHCARE RESMED CEFUROXIME 250 INJECTION EACH VIAL CEFUROXIME SODIUM CEFUROXIME 250,0 A38/20.1.1/0665 PHARMACARE LIMITED CLARIDE 250 CLARITHROMYCIN 250,0 A38/20.1.1/0666 PHARMACARE LIMITED CLARIDE 500 CLARITHROMYCIN 500,0 A38/34/0669 A38/34/0670 A38/34/0671 A38/34/0672 A38/34/0673 A38/34/0674 A38/20.2.2/0691 A38/1.2/0706 A39/21.2/0023 A39/21.2/0024 A39/21.2/0025 BIOGARAN SOUTH AFRICA BIOGARAN SOUTH AFRICA EGIS (SA) EGIS (SA) SERVIER LABORATORIES SOUTH AFRICA SERVIER LABORATORIES SOUTH AFRICA XIXIA HEXAL PHARMA (SA) HEXAL PHARMA (SA) HEXAL PHARMA (SA) STROMOS 1 G STROMOS 2 G PAROSTAN 1 G PAROSTAN 2 G PROTOS 1 G PROTOS 2 G MERCK-TERBINAFINE 250 MG () PAXOTENE 20 MG GLIMEHEXAL 1 GLIMEHEXAL 2 GLIMEHEXAL 4 EACH SACHET STRONTIUM RANELATE 1,0 g EACH SACHET STRONTIUM RANELATE 2,0 g EACH SACHET STRONTIUM RANELATE 1,0 g EACH SACHET STRONTIUM RANELATE 2,0 g EACH SACHET STRONTIUM RANELATE 1,0 g EACH SACHET STRONTIUM RANELATE 2,0 g TERBINAFINE TERBINAFINE 250,0 PAROXETINE PAROXETINE 20,0 GLIMEPIRIDE 1,0 GLIMEPIRIDE 2,0 GLIMEPIRIDE 4, Notification of Registration 23 Sept 2005v2.doc Feb 2006 Page 11 of 13
12 A39/20.2.8/0030 A39/20.1.1/0044 A39/20.1.1/0045 A39/20.1.1/0046 GLAXOSMITHKLINE SOUTH AFRICA (PTY) KIVEXA ABACAVIR SULPHATE ABACAVIR 600,0 LAMIVUDINE 300,0 -CIPROFLOXACIN 250 MG CIPROFLOXACIN CIPROFLOXACIN 250,0 -CIPROFLOXACIN 500 MG -CIPROFLOXACIN 750 MG CIPROFLOXACIN CIPROFLOXACIN 500,0 CIPROFLOXACIN CIPROFLOXACIN 750,0 A39/20.1.2/0070 SANDOZ CURAM BD SUSPENSION EACH 5,0 ml SUSPENSION AMOXYCILLIN TRIHYDRATE AMOXYCILLIN 400,0 POTASSIUM CLAVULANATE CLAVULANIC ACID 57.0 A39/20.1.2/0071 SANDOZ SANDOZ CO- AMOXYCLAV BD SUSPENSION EACH 5,0 ml SUSPENSION AMOXYCILLIN TRIHYDRATE AMOXYCILLIN 400,0 POTASSIUM CLAVULANATE CLAVULANIC ACID 57.0 A39/19/0074 SPECPHARM SPEC-OXYTOCIN 10 EACH 1,0 ml AMPOULE OXYTOCIN 10,0 i.u. A39/20.1.1/0113 RESMED HEALTHCARE REZOLIN 500 INJECTION EACH VIAL CEFAZOLIN SODIUM CEFAZOLIN 500,0 A39/20.1.1/0114 RESMED HEALTHCARE REZOLIN 1000 INJECTION EACH VIAL CEFAZOLIN SODIUM CEFAZOLIN 1000,0 A39/5.4.1/0124 GENERIX INTERNATIONAL SA PARKILYNE SELEGILINE 5,0 A39/20.1.1/0179 RESMED HEALTHCARE REZONE 2000 INJECTION EACH VIAL CEFTRIAXONE SODIUM CEFTRIAXONE 2000, Notification of Registration 23 Sept 2005v2.doc Feb 2006 Page 12 of 13
13 A39/2.8/0237 PHARMACARE LIMITED MYBULEN SUSPENSION EACH 10,0 ml SUSPENSION IBUPROFEN 200,0 CODEINE PHOSPHATE 10,0 PARACETAMOL 250,0 A39/11.5/0260 PHARMACARE LIMITED LENNON LACTULOSE EACH 5,0 ml SOLUTION PEACH LACTULOSE ANHYDROUS A39/11.5/0263 PHARMACARE LIMITED LENNON LACTULOSE LEMON A39/20.2.8/0280 STRIDES SA DAS-LAMIVUDINE 150 MG A39/10.2.1/0373 ADCOCK INGRAM SABAX COMBINEB CRITICAL CARE (PTY) 3,250 g EACH 5,0 ml SOLUTION LACTULOSE ANHYDROUS 3,250 g LAMIVUDINE 150,0 EACH 2,5 ml SOLUTION IPRATROPIUM BROMIDE 0,520 SALBUTAMOL SULPHATE 3,010 A39/18.1/0399 PHARMACARE LIMITED RIDAQ-12,5 HYDROCHLOROTHIAZIDE 12,5 A39/2.5/0473 SANDOZ SANDOZ LAMOTRIGINE 25 LAMOTRIGINE 25,0 A39/2.5/0474 SANDOZ SANDOZ LAMOTRIGINE 50 LAMOTRIGINE 50,0 A39/2.5/0475 SANDOZ SANDOZ LAMOTRIGINE 100 LAMOTRIGINE 100,0 A39/2.5/0476 SANDOZ SANDOZ LAMOTRIGINE 200 LAMOTRIGINE 200,0 A39/2.5/0513 SANDOZ LAMEPTIL 25 LAMOTRIGINE 25,0 A39/2.5/0514 SANDOZ LAMEPTIL 50 LAMOTRIGINE 50,0 A39/2.5/0515 SANDOZ LAMEPTIL 100 LAMOTRIGINE 100,0 A39/2.5/0516 SANDOZ LAMEPTIL 200 LAMOTRIGINE 200,0 A40/3.1/0028 SANDOZ ARTHROCOX 15 MELOXICAM 15,0 A40/2.2/0054 A40/2.2/0055 A40/2.2/0056 GENERIX INTERNATIONAL SA GENERIX INTERNATIONAL SA GENERIX INTERNATIONAL SA ZOLAMID 5 MG/5 ML ZOLAMID 15 MG/3 ML ZOLAMID 50 MG/10 ML EACH AMPOULE MIDAZOLAM 5,0 EACH AMPOULE MIDAZOLAM 15,0 EACH AMPOULE MIDAZOLAM 50,0 REGISTRAR OF MEDICINES DR ZOKUFA Notification of Registration 23 Sept 2005v2.doc Feb 2006 Page 13 of 13
MEDICINES CONTROL COUNCIL
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
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)
MEDICINES CONTROL COUNCIL
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
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)
MEDICINES CONTROL COUNCIL
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) 41/20.1.1/0039 SCP MYLAN
MEDICINES CONTROL COUNCIL
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
MEDICINES CONTROL COUNCIL
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) 08/5.1/09 INGELHEIM 08/5.1/10
MEDICINES CONTROL COUNCIL
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