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SL. NAME OF INDIAN OVERSEASE NAME OF COMPOSITION INDICATION PERMISSION PERMISSION NO. COMPANY. MANUFACTURER PRODUCT NO DATE COMPANY 1 GlaxoSmithKline Glaxosmithkline Oral Each 0.1ml For active Import 04.09.2008 Pharmaceuticals (GSK) Biologicals Poliomyelitis dose (2 drops) immunization 964/08 Asia Pvt. Ltd., S.A, Belgium. Type 3 Vaccine contains: against Patiala Road, (Monovalent). Poliomyelitis Poliomyelitis Nabha 147201, viruse type – 3 Type 3 Punjab. at least 105.8 CCID50 (Strain-Sabin) 2 GlaxoSmithKline Glaxosmithkline Oral Each 0.1ml dose For active Import - 04.09.2008 Pharmaceuticals (GSK) Biologicals Poliomyelitis (2 drops) immunization 965/08 Asia Pvt. Ltd., S.A, Belgium. Type 1 Vaccine contains against Patiala Road, (Monovalent) Poliomyelitis Poliomyelitis virus type 1 at Nabha 147201, Type 1 least 106.0 Punjab. CCID50. 3 GlaxoSmithKline Glaxosmithkline Human Each 0.5ml dose It is indicated Import 30/9/2008 Pharmaceuticals (GSK) Biologicals Papilomavirus contains:- in females 955/08 Asia Pvt. Ltd., S.A, Belgium. Vaccine Human from 10-45 Patiala Road, Papilomavirus years of age type 16L1, Nabha 147201, for the Protein - 20 Punjab. prevention of microgram, Human cervical Papilomavirus cancer by type 18L1, protecting Protein - 20 against micrograms incideence and persistent infection, Cytogenical abonormality including a typical squamous cell of undetermine significance and cervical intraepithelial neo plasia (CIN), CIN 1 and pre cancerous lesions (CIN 2 and CIN 3) 4 Novartis Novartis vaccines Oral Each 0.1ml For active Import 04.09.2008 helathcare Pvt. and Diagnostics / Poliomyelitis dose (2 drops) immunization 961/08 Ltd., Sandoz siena, Italy. Type 1 Vaccine contains: against House, (Monovalent). Poliomyelitis Poliomyelitis Shivsagar (For Unicef virus type – 1 Type 1. Estate, Dr. only) at least 10 6.0 Annie Beasant CCID50 (Strain- Road, Worli, Sabin). Mumbai – 400018. 5 Novartis Novartis vaccines Oral Each 0.1ml For active Import 04.09.2008 helathcare Pvt. and Diagnostics / Poliomyelitis dose (2 drops) immunization 962/08 Ltd., Sandoz siena, Italy. Type 3 vaccine contains: against House, (Monovalent). Poliomyelitis Poliomyelitis Shivsagar (For Unicef virus type – 1 Type 3. Estate, Dr. only) at least 10 5.8 Annie Beasant CCID50 (Strain- Road, Worli, Sabin). Mumbai – 400018. 6 Novartis Novartis vaccines Oral Each 0.1ml dose For active Import 963/08 04.09.2008 helathcare Pvt. and Diagnostics / Poliomyelitis (2 drops) immunization Ltd., Sandoz siena, Italy. Type 1, Type 2, contains: against House, & Type 3 Poliomyelitis Poliomyelitis virus type 1 – at Shivsagar vaccine Type 1, Type 2 & least 106.0 Estate, Dr. (Trivalent) Type 3. CCID50 Annie Beasant Poliomyelitis Road, Worli, virus type 1 – at Mumbai – least 105.0 400018 CCID50 Poliomyelitis virus type 1 – at least 105.5 CCID50 (Strain- Sabin) 7 Roche Scintific Chugai Tocilizumab. Each vial of 4ml / For the disease Import–930/08 29.08.2008 Company (India) pharmaceutical 10ml / 20ml / which do not Pvt. Ltd., 165, Dr. company limited, contains: show sufficient A.B.Road, Worli, Tokyo, Japan. Toclizumab – response to the Mumbai – 400018. 20mg/ml. existing therapies:- e.g. Rheumatoid arhtritis (Including inhibition of progression of structural joint damage), Polyarticular- course juvenile idiopathic arthritis. Improvent of various symptoms (e.g. generalised fatigue) and laboratory findings (Increased C- reactive protein, fibrinogen, and erythrocyte 8 Shreya Life Sciences Sandoz GmbH Recombinant (1) Powder for Long term Import 966/08 05.09.2008 Pvt. Ltd., Shreya Biochemister, Human Growth Injection: Each treatment of vial after House, 301/A, Kundl, Austria. Hormone. children who reconstitution Pereira Hill Road, have growth contains Andheri (E), Mumbai Recombinant failure due to – 400099. Human Growth endogenous Hormone 5.8mg. growth hormone (2) Solution for and for the injection: Each treatement of cartidge of 1.5ml short steature in contains Recombinant children with Human Growth turner’s Hormone 5mg syndrome (15IU) and 10mg conmfirmed by (30IU). chromosomal analysis. 9 Sanofi Pasture India Sanofi Pasture Combination of Each 0.5ml dose For the active Import 877/08 21.08.2008 Pvt. Ltd., D-2, Fourth limited, Ontario, Tetanus Toxoids + contains: Tetanus immunization against Floor, Southern Toronto, Canada. Diptheria Toxoids Toxoids – 5Lf, Tetanus, Park, DDA Component Diptheria Toxoids Diptheria and Commercial Center, Pertusis Vaccine. – 2Lf, Pertusis Pertusis. Saket, New Delhi - Toxoids – 2.5mcg, 110017 Fimbrial Agglutiongens 2+3 – 5mcg, Filamentous Haemagglutinin – 5mcg, Pertactin (PRN) – 3mcg 10 Sanofi Pasteur India Sanofi Pasture, Oral Poliomyelitis Each 0.1ml dose For active Import 717/08 30.06.2008 Pvt. Ltd., D-2, Fourth Lyon, France Type 1 Vaccine (2 drops) contains immunization Floor, Southern (Monovalent). Poliomyelitis virus against Park, DDA type 1 at least Poliomyelitis type Commercial Center, 106.0 CCID50. 1. Saket, New Delhi - 110017 11 Sudershan Biotech Beijing Four Recombinant Each prefilled For the IMP-42/08 17.01.2008 Limited, 4-100, C/9 Rings Human syringe contains: r-treatement of Biopharmaceutica & C/10, L.B. Nagar, Granulocyte Human neutrophilic ls Co. Ltd, China. Hyderabad – Colony Stimulating Granulocyte granulocytopenia 500074. Factor Injection. Colony reduced by Stimulating Factor chemotherapy of – cancer and bone 75mcg/150mcg/3 marrow 00mcg. transplantation. 12 Reliance Nova Laboratories, Recombinant Each prefilled For the treatment IMP-177/08 30.01.2008 Biopharmaceuticals UK. Human syringe contains of anemia due to Pvt. Ltd., R-282, TTC, Erythropoietin Recombinant chronic renal Industrial Area, Injection Human failure patients. Thane – Belapur Erythropoietin Road, Rebale, Navi 10,000 IU/ml. Mumbai – 400701.
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