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Administration Notification of Registration 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)
Application Holder of Certificate of
Proprietary Name Active Compound
Number Registration
08/3.1.2/14 INGELHEIM METACAM 20 mg/ml Each 1,0 ml solution contains:
PHARMACEUTICALS FOR CATTLE, PIGS MELOXICAM 20,0 mg
(PTY) LTD AND HORSES
A39/34/0605 NOVARTIS SOUTH NICOTINELL FRUIT Each chewing gum contains:
AFRICA (PTY) LTD 2 mg COATED NICOTINE 2,0 mg
CHEWING GUM
A39/34/0606 NOVARTIS SOUTH NICOTINELL FRUIT Each chewing gum contains:
AFRICA (PTY) LTD 4 mg COATED NICOTINE 4,0 mg
CHEWING GUM
A39/34/0607 NOVARTIS SOUTH NICOTINELL MINT 2 mg Each chewing gum contains:
AFRICA (PTY) LTD COATED CHEWING NICOTINE 2,0 mg
GUM
A39/34/0608 NOVARTIS SOUTH NICOTINELL MINT 4 mg Each chewing gum contains:
AFRICA (PTY) LTD COATED CHEWING NICOTINE 4,0 mg
GUM
41/11.10/0215 RECKITT BENCKISER GAVISCON LIQUISHOT Each sachet contains:
PHARMACEUTICALS SODIUM ALGINATE 500,0 mg
(PTY) LTD
41/21.10/0523 SERONO SA (PTY) LTD OVITRELLE Each 0,5 ml solution contains:
250 µg/0,5 ml CHORIOGONADOTROPIN
ALFA 250,0 µg
42/26/0608 PHARMACARE LIMITED ASPEN CARBOPLATIN Each 5,0 ml vial contains:
50 mg CARBOPLATIN 50,0 mg
42/26/0609 PHARMACARE LIMITED ASPEN CARBOPLATIN Each 15,0 ml vial contains:
150 mg CARBOPLATIN 150,0 mg
42/26/0610 PHARMACARE LIMITED ASPEN CARBOPLATIN Each 45,0 ml vial contains:
450 mg CARBOPLATIN 450,0 mg
42/20.1.1/0247 PHARMACARE LIMITED ASPEN Each vial contains:
AZITHROMYCIN IV AZITHROMYCIN
MONOHYDRATE equivalent to
AZITHROMYCIN 500,0 mg
Document1 June 2012 Page 1 of 5
Administration Notification of Registration of Medicines
Application Holder of Certificate of
Proprietary Name Active Compound
Number Registration
42/21.5.1/0310 XIXIA MYLAN METHYL- Each vial contains:
PHARMACEUTICALS PREDNISOLONE 120 METHYLPREDNISOLONE
(PTY) LTD HEMISUCCINATE equivalent to
METHYLPREDNISOLONE
120,0 mg
42/21.5.1/0311 XIXIA MYLAN METHYL- Each vial contains:
PHARMACEUTICALS PREDNISOLONE 500 METHYLPREDNISOLONE
(PTY) LTD HEMISUCCINATE equivalent to
METHYLPREDNISOLONE
500,0 mg
42/21.5.1/0312 XIXIA MYLAN METHYL- Each vial contains:
PHARMACEUTICALS PREDNISOLONE METHYLPREDNISOLONE
(PTY) LTD 1 000 HEMISUCCINATE equivalent to
METHYLPREDNISOLONE
1 000,0 mg
42/7.1.3/0352 PHARMACARE LIMITED TRANDOPRESS 0,5 mg Each capsule contains:
TRANDOLAPRIL 0,5 mg
42/20.1.1/0641 GULF DRUG COMPANY GULF CEFOTAXIME 2 g Each vial contains:
(PTY) LTD CEFOTAXIME SODIUM
equivalent to
CEFOTAXIME 2,0 g
42/7.5/0805 PHARMACARE LIMITED VATICOL XL Each tablet contains:
FLUVASTATIN SODIUM
equivalent to
FLUVASTATIN 80,0 mg
42/7.1.3/0947 RANBAXY SA (PTY) LTD IRBELO 75 Each tablet contains:
IRBESARTAN 75,0 mg
42/7.1.3/0948 RANBAXY SA (PTY) LTD IRBELO 150 Each tablet contains:
IRBESARTAN 150,0 mg
42/7.1.3/0949 RANBAXY SA (PTY) LTD IRBELO 300 Each tablet contains:
IRBESARTAN 300,0 mg
42/7.1.3/0950 RANBAXY SA (PTY) LTD RAN IRBESARTAN 75 Each tablet contains:
IRBESARTAN 75,0 mg
42/7.1.3/0951 RANBAXY SA (PTY) LTD RAN IRBESARTAN 150 Each tablet contains:
IRBESARTAN 150,0 mg
42/7.1.3/0952 RANBAXY SA (PTY) LTD RAN IRBESARTAN 300 Each tablet contains:
IRBESARTAN 300,0 mg
42/26/0965 XIXIA MYLAN CARBOPLATIN Each vial contains:
PHARMACEUTICALS 150 CARBOPLATIN 150,0 mg
(PTY) LTD
42/26/0966 XIXIA MYLAN CARBOPLATIN Each vial contains:
PHARMACEUTICALS 450 CARBOPLATIN 450,0 mg
(PTY) LTD
42/2.9/0967 PHARMACARE LIMITED TRAMASPEN 50 mg Each capsule contains:
TRAMADOL HYDROCHLORIDE
50,0 mg
42/21.12/1096 ASTRAZENECA EVERDEX 1 mg Each tablet contains:
PHARMACEUTICALS ANASTROZOLE 1,0 mg
(PTY) LTD
43/2.6.5/0039 TRINITY PHARMA (PTY) RISPEVON 1 Each tablet contains:
LTD RISPERIDONE 1,0 mg
43/2.6.5/0040 TRINITY PHARMA (PTY) RISPEVON 2 Each tablet contains:
LTD RISPERIDONE 2,0 mg
Document1 June 2012 Page 2 of 5
Administration Notification of Registration of Medicines
Application Holder of Certificate of
Proprietary Name Active Compound
Number Registration
43/2.6.5/0041 TRINITY PHARMA (PTY) RISPEVON 3 Each tablet contains:
LTD RISPERIDONE 3,0 mg
43/2.6.5/0042 TRINITY PHARMA (PTY) RISPEVON 4 Each tablet contains:
LTD RISPERIDONE 4,0 mg
43/26/0046 XIXIA MYLAN GEMCITABINE Each vial contains:
PHARMACEUTICALS 1g GEMCITABINE equivalent to
(PTY) LTD GEMCITABINE 1,0 g
43/20.1.1/0062 ORCHID ORCHID CEFUROXIME Each tablet contains:
PHARMACEUTICALS SA 250 mg CEFUROXIME AXETIL
(PTY) LTD equivalent to
CEFUROXIME 250,0 mg
43/20.1.1/0063 ORCHID ORCHID CEFUROXIME Each tablet contains:
PHARMACEUTICALS SA 500 mg CEFUROXIME AXETIL
(PTY) LTD equivalent to
CEFUROXIME 500,0 mg
43/26/0068 XIXIA MYLAN GEMCITABINE Each vial contains:
PHARMACEUTICALS 200 mg GEMCITABINE equivalent to
(PTY) LTD GEMCITABINE 200,0 mg
43/20.1.1/0221 BRIMPHARM SA (PTY) ZEEMIDE 500 mg Each tablet contains;
LTD AZITHROMYCIN DIHYDRATE
equivalent to
AZITHROMYCIN 500,0 mg
43/11.4.3/0545 PHARMACARE LIMITED ASPEN Each tablet contains:
PANTOPRAZOLE 20 PANTOPRAZOLE SODIUM
SESQUIHYDRATE equivalent to
PANTOPRAZOLE 20,0 mg
43/11.4.3/0546 PHARMACARE LIMITED ASPEN Each tablet contains:
PANTOPRAZOLE 40 PANTOPRAZOLE SODIUM
SESQUIHYDRATE equivalent to
PANTOPRAZOLE 40,0 mg
43/20.2.8/0570 AUROBINDO PHARMA VUDERIT 30 mg Each tablet contains:
(PTY) LTD LAMIVUDINE 150,0 mg
STAVUDINE 30,0 mg
43/20.2.8/0571 AUROBINDO PHARMA VUDERIT 40 mg Each tablet contains:
(PTY) LTD LAMIVUDINE 150,0 mg
STAVUDINE 40,0 mg
43/2.5/0823 TRINITY PHARMA (PTY) EPIMATE 25 Each tablet contains:
LTD TOPIRAMATE 25,0 mg
43/2.5/0824 TRINITY PHARMA (PTY) EPIMATE 50 Each tablet contains:
LTD TOPIRAMATE 50,0 mg
43/2.5/0825 TRINITY PHARMA (PTY) EPIMATE 100 Each tablet contains:
LTD TOPIRAMATE 100,0 mg
43/2.5/0826 TRINITY PHARMA (PTY) EPIMATE 200 Each tablet contains:
LTD TOPIRAMATE 200,0 mg
43/11.4.3/1001 NYCOMED (PTY) LTD PANTOLOC OTC Each tablet contains:
PANTOPRAZOLE SODIUM
SESQUIHYDRATE equivalent to
PANTOPRAZOLE 20,0 mg
43/1.2/1015 ZYDUS HEALTHCARE SA ZYDUS Each tablet contains;
(PTY) LTD ESCITALOPRAM 10 mg ESCITALOPRAM OXALATE
EQUIVALENT TO
ESCITALOPRAM 10,0 mg
Document1 June 2012 Page 3 of 5
Administration Notification of Registration of Medicines
Application Holder of Certificate of
Proprietary Name Active Compound
Number Registration
43/7.1.3/1044 AUROBINDO PHARMA BIQURETIC 10/12,5 mg Each tablet contains;
(PTY) LTD QUINAPRIL HYDROCHLORIDE
equivalent to
QUINAPRIL 10,0 mg
HYDROCHLOROTHIAZIDE
12,5 mg
43/7.1.3/1045 AUROBINDO PHARMA BIQURETIC 20/12,5 mg Each tablet contains;
(PTY) LTD QUINAPRIL HYDROCHLORIDE
equivalent to
QUINAPRIL 20,0 mg
HYDROCHLOROTHIAZIDE
12,5 mg
43/7.1.3/1046 AUROBINDO PHARMA AURO QUINAPRIL CO Each tablet contains;
(PTY) LTD 10/12,5 mg QUINAPRIL HYDROCHLORIDE
equivalent to
QUINAPRIL 10,0 mg
HYDROCHLOROTHIAZIDE
12,5 mg
43/7.1.3/1047 AUROBINDO PHARMA AURO QUINAPRIL CO Each tablet contains;
(PTY) LTD 20/12,5 mg QUINAPRIL HYDROCHLORIDE
equivalent to
QUINAPRIL 20,0 mg
HYDROCHLOROTHIAZIDE
12,5 mg
44/20.1.1/0316 BIOTECH KANAMYCIN 1 g Each ampoule contains:
LABORATORIES (PTY) BIOTECH KANAMYCIN SULPHATE
LTD equivalent to
KANAMYCIN 1 000,0 mg
44/34/0391 CIPLA MEDPRO (PTY) SOLVENT FOR Each vial contains:
LTD DOCELEX 20 ETHANOL 13,0 % m/v
44/34/0392 CIPLA MEDPRO (PTY) SOLVENT FOR Each vial contains:
LTD DOCELEX 80 ETHANOL 13,0 % m/v
44/8.1/0550 NOVO NORDISK (PTY) NOVOSEVEN 1 mg Each vial contains:
LTD ACTIVATED RECOMBINANT
COAGULATION FACTOR VIIa
(rFVIIa) 1,0 mg
44/8.1/0551 NOVO NORDISK (PTY) NOVOSEVEN 2 mg Each vial contains:
LTD ACTIVATED RECOMBINANT
COAGULATION FACTOR VIIa
(rFVIIa) 2,0 mg
44/8.1/0552 NOVO NORDISK (PTY) NOVOSEVEN 5 mg Each vial contains:
LTD ACTIVATED RECOMBINANT
COAGULATION FACTOR VIIa
(rFVIIa) 5,0 mg
44/13.9.1/0632 ADCOCK INGRAM XAMIOL GEL Each gram contains:
LIMITED CALCIPOTRIOL HYDRATE
equivalent to
CALCIPOTRIOL 50,0 µg
BETAMETHASONE
DIPROPIONATE equivalent to
BETAMETHASONE 0,5 mg
45/20.2.8/0111 MYLAN (PTY) LTD RILOVIA 200/50 Each tablet contains:
LOPINAVIR 200,0 mg
RITONAVIR 50,0 mg
Document1 June 2012 Page 4 of 5
Administration Notification of Registration of Medicines
Application Holder of Certificate of
Proprietary Name Active Compound
Number Registration
45/20.2.8/0112 MYLAN (PTY) LTD TENEMINE Each tablet contains:
TENOFOVIR DISOPROXIL
FUMARATE 300,0 mg
EMTRICITABINE 200,0 mg
45/20.2.8/0169 MYLAN (PTY) LTD EFRIN Each tablet contains:
EFAVIRENZ 600,0 mg
45/20.2.8/0336 MYLAN (PTY) LTD RILOVIA 100/25 Each tablet contains:
LOPINAVIR 100,0 mg
RITONAVIR 25,0 mg
45/20.2.8/0538 MACLEODS MACLEODS Each tablet contains:
PHARMACEUTICALS SA LAMIVUDINE 150 LAMIVUDINE 150,0 mg
(PTY) LTD
MS MANDISA HELA
REGISTRAR OF MEDICINES
Document1 June 2012 Page 5 of 5
