MEDICINES CONTROL COUNCIL
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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) A05/21.1/02 DRAXXIN 100 mg/ml 29/34/0761 AIR LIQUIDE AIR LIQUIDE MEDICAL NITROUS OXIDE 32/7.1/0428 HEXAL PHARMA (SA) DILTIAZEM HEXAL 90 TULATHROMYCIN 100,0 mg EACH CYLINDER NITROUS OXIDE 100,0 % DILTIAZEM 90,0 mg 34/16.1/0366 MERCK ILIADIN 0,01 % OXYMETAZOLINE 0,1 mg 36/2.7/0183 BRISTOL-MYERS SQUIBB 37/30.1/0221 GLAXOSMITHKLINE SOUTH AFRICA EXCEDRIN TRITANRIX-HB + HIBERIX COMBO PACK PARACETAMOL 250,0 mg ASPIRIN 250,0 mg CAFFEINE 65,0 mg EACH COMBO PACK TRITANRIX-HB INJECTION CONTAINING PER 0,5 ml DOSE: DIPHTHERIA TOXOID 30,0 I.U. TETANUS TOXOID 60,0 I.U. INACTIVATED BORDETELLA PERTUSSIS 4,0 I.U. HEPATITIS B VIRUS SURFACE ANTIGEN 10,0 μg Notification of Dec06v2.doc April 2007 Page 1 of 6
2 Notification of of Medicines 37/26/0538 KEY ONCOLOGICS (PTY) 37/26/0539 KEY ONCOLOGICS (PTY) 37/11.1/0629 AVENTIS PHARMA (PTY) 38/16.4/0021 EPIRUBICIN-LEMERY 10 mg EPIRUBICIN-LEMERY 50 mg ASACOL 800 TEETH AND GUM DEFENCE LISTERINE 38/2.6.5/0030 ELI LILLY (S.A.) ZYPREXA VELOTAB 5 mg 38/11.10/0070 ASTELLAS PHARMA (PTY) 38/11.10/0071 ASTELLAS PHARMA (PTY) MOASON 500 SUPPOSITORIES MOASON 250 SUPPOSITORIES 38/2.6.5/0073 ELI LILLY (S.A.) ZYPREXA VELOTAB 10 mg 38/13.1/0194 MEDICINE DEVELOPERS INTERNATIONAL cc 38/30.3/0281 ADCOCK INGRAM CRITICAL CARE 38/30.3/0282 ADCOCK INGRAM CRITICAL CARE 38/30.3/0283 ADCOCK INGRAM CRITICAL CARE A38/21.2/0681 A38/21.2/0682 A38/7.5/0710 A38/7.5/0711 A38/7.5/0712 GULF DRUG COMPANY GULF DRUG COMPANY ARROW PHARMA SOUTH AFRICA ARROW PHARMA SOUTH AFRICA ARROW PHARMA SOUTH AFRICA POVIGEL IMMUNINE 200 I.U. IMMUNINE 600 I.U. IMMUNINE I.U. FORMINAL 500 FORMINAL 850 BIOVAC SIMVASTATIN 10 BIOVAC SIMVASTATIN 20 BIOVAC SIMVASTATIN 40 HIBERIX VACCINE CONTAINING PER 0,5 ml DOSE: HAEMOPHILUS INFLUENZA TYPE b 10,0 μg EACH VIAL EPIRUBICIN 10,0 mg EACH VIAL EPIRUBICIN 50,0 mg MESALAZINE 800,0 mg EACH 20,0 ml SOLUTION SODIUM FLUORIDE 4,420 mg THYMOL 12,780 mg ALCOHOL (95 %) 4,540 ml OLANZAPINE 5,0 mg EACH SUPPOSITORY MESALAZINE 500,0 mg EACH SUPPOSITORY MESALAZINE 250,0 mg OLANZAPINE 10,0 mg EACH 1,0 g GEL POVIDONE IODINE 100,0 mg EACH VIAL HUMAN COAGULATION FACTOR IX 200,0 I.U. EACH VIAL HUMAN COAGULATION FACTOR IX 600,0 I.U. EACH VIAL HUMAN COAGULATION FACTOR IX 1 200,0 I.U. METFORMIN 500,0 mg METFORMIN 850,0 mg SIMVASTATIN 10,0 mg SIMVASTATIN 20,0 mg SIMVASTATIN 40,0 mg Notification of Dec06v2.doc April 2007 Page 2 of 6
3 Notification of of Medicines A39/7.5/0017 ASPAVOR 10 ATORVASTATIN CALCIUM ATORVASTATIN 10,0 mg A39/7.5/0018 ASPAVOR 20 ATORVASTATIN CALCIUM ATORVASTATIN 20,0 mg A39/7.5/0019 ASPAVOR 40 ATORVASTATIN CALCIUM ATORVASTATIN 40,0 mg A39/20.2.8/0112 LEBASI cc VARI-NEVIRAPINE 200 mg NEVIRAPINE 200,0 mg A39/11.5/0115 PHARMA DYNAMICS ISPAGEL EACH SACHET ISPAGHULA HUSK 3,5 g A39/11.5/0135 PHARMA DYNAMICS PHARMA DYNAMICS ISPAGHULA HUSK EACH SACHET ISPAGHULA HUSK 3,5 g A39/23/0182 FRESENIUS KABI SOUTH AFRICA AMINOVEN INFANT 10 % EACH 1 000,0 ml SOLUTION TOTAL AMINO ACIDS 100,0 g L-isoleucine 8,00 g L-leucine 13,00 g L-methionine 3,12 g L-lysine-acetate 12,00 g L-phenylalanine 3,75 g L-threonine 4,40g L-tryptophan 2,01g L-valine 9,00 g L-arginine 7,50 g L-histidine 4,76 g L-alanine 9,30 g Glycine 4,15 g L-proline 9,17 g L-serine 7,67 g N-acetyl-L-cysteine 0,77 g Taurine 0,40 g N-acetyl-L-tyrosine 5,176 g L-malic acid 2,62 g A39/25.2/0275 ADCOCK INGRAM CRITICAL CARE OLICLINOMEL N8-800 EACH BAG a) 12 % AMINO ACIDS SOLUTION compartment containing per 1,0 litre: L-alanine 25,88 g L-arginine 14,38 g Glycine 12,88 g L-histidine 6,00 g L-isoleucine 7,50 g L-leucine 9,13 g L-lysine 7,25 g L-methionine 5,00 g L-phenylalanine 7,00 g L-proline 8,50 g Notification of Dec06v2.doc April 2007 Page 3 of 6
4 Notification of of Medicines L-serine 6,25 g L-threonine 5,25 g L-tryptophan 2,25 g L-tyrosine 0,50 g L-valine 7,25 g b) 31,25 % GLUCOSE SOLUTION compartment containing per 1,0 litre: Glucose monohydrate equivalent to Glucose 312,50 g c) 15 % LIPID EMULSION compartment containing per 1,0 litre: Refined soya-bean oil + Refined olive oil 150,00 g A39/20.2.8/0279 STRIDES S.A. DAS-STAVUDINE 40 mg EACH CAPSULE STAVUDINE 40,0 mg A39/20.1.1/0303 A39/20.2.8/0343 A39/20.2.8/0344 A39/28/0614 A39/20.1.1/0618 A39/20.1.1/0619 A39/24/0620 A39/24/0621 CAMOX CAMOX CAMOX TYCO HEALTHCARE RANBAXY (S.A.) (PTY) RANBAXY (S.A.) (PTY) B. BRAUN MEDICAL (PTY) B. BRAUN MEDICAL (PTY) APEX-CEFTRIAXONE 1 g APEX-ACYCLOVIR 200 mg APEX-ACYCLOVIR 400 mg OPTIRAY ml RAN-CLARITHROMYCIN MR 500 mg KLARITHRAN MR 500 B BRAUN 7,45 % B BRAUN 14,9 % A40/20.1.1/0019 SPECPHARM SPEC-CEFAXONE 250 mg A40/20.1.1/0020 SPECPHARM SPEC-CEFAXONE 500 mg EACH VIAL CEFTRIAXONE 1,0 g ACYCLOVIR 200,0 mg ACYCLOVIR 400,0 mg IOVERSOL 300,0 mg CLARITHROMYCIN 500,0 mg CLARITHROMYCIN 500,0 mg EACH 100,0 ml SOLUTION 7,456 g EACH 100,0 ml SOLUTION 14,9 g EACH VIAL CEFTRIAXONE 250,0 mg EACH VIAL CEFTRIAXONE 500,0 mg Notification of Dec06v2.doc April 2007 Page 4 of 6
5 Notification of of Medicines A40/20.1.1/0021 SPECPHARM SPEC-CEFAXONE 1 g EACH VIAL CEFTRIAXONE 1 000,0 mg A40/10.2.1/0064 GLAXOSMITHKLINE SOUTH AFRICA SEREVENT INHALER CFC-FREE EACH ACTUATION DELIVERS: SALMETEROL XINAFOATE SALMETEROL 25,0 μg A40/7.1/0106 PHARMAPLAN ZANIDIP 20 LERCANIDIPINE 10,0 mg A40/15.1/0164 A40/21.2/0193 A40/21.2/0194 A40/21.2/0195 A40/21.2/0196 A40/34/0258 ALCON LABORATORIES (S.A.) S.A. S.A. S.A. S.A. TEVA A40/20.1.2/0285 DEZZO TRADING (392) t/a INDO PHARMA A40/5.10/0322 VIGAMOX EYE DROPS 1 mg 2 mg 3 mg 4 mg COPAXONE 20 mg/ml FLUPEN-250 ONICIT MOXIFLOXACIN MOXIFLOXACIN 5,0 mg GLIMEPIRIDE 1,0 mg GLIMEPIRIDE 2,0 mg GLIMEPIRIDE 3,0 mg GLIMEPIRIDE 4,0 mg GLATIRAMER ACETATE 20,0 mg EACH CAPSULE FLUCLOXACILLIN SODIUM FLUCLOXACILLIN 250,0 mg CONTAINS; PALONOSETRON PALONOSETRON 50,0 μg A40/11.4.3/0482 PHARMAPLAN PANTOCID 40 PANTOPRAZOLE SODIUM SESQUIHYDRATE PANTOPRAZOLE 40,0 mg A40/3.2/0514 SANDOZ OSTOMIR 70 ALENDRONATE SODIUM ALENDRONIC ACID 70,0 mg Notification of Dec06v2.doc April 2007 Page 5 of 6
6 Notification of of Medicines A40/3.2/0515 SANDOZ SANDOZ ALENDRONATE 70 A40/20.2.3/0534 AVENTIS PHARMA (PTY) RIFINAH 150/75 A40/1.2/0584 SANDOZ SANDOZ MIRTAZAPINE 15 A40/1.2/0585 SANDOZ SANDOZ MIRTAZAPINE 30 A40/1.2/0586 SANDOZ SANDOZ MIRTAZAPINE 45 A40/1.2/0654 A40/1.2/0655 AUROBINDO PHARMA AUROBINDO PHARMA AUROLIFT 50 mg AUROLIFT 100 mg ALENDRONATE SODIUM ALENDRONIC ACID 70,0 mg RIFAMPICIN 150,0 mg ISONIAZID 75,0 mg MIRTAZAPINE 15,0 mg MIRTAZAPINE 30,0 mg MIRTAZAPINE 45,0 mg SERTRALINE SERTRALINE 50,0 mg SERTRALINE SERTRALINE 100,0 mg A40/20.2.3/0680 PHARMACARE LIMITED CAPASTAT 1 g EACH VIAL CAPREOMYCIN SULPHATE CAPREOMYCIN 1,0 g A40/7.1.3/0682 SANDOZ SANDOZ RAMIPRIL 10 RAMIPRIL 10,0 mg A40/7.1.3/0683 SANDOZ RAMIPRIL-HEXAL 10 RAMIPRIL 10,0 mg A40/7.1.3/0684 SANDOZ RETACE 10 RAMIPRIL 10,0 mg REGISTRAR OF MEDICINES MS MANDISA HELA Notification of Dec06v2.doc April 2007 Page 6 of 6
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