Legal Supplement Part B Vol. 40, No th May, NOTIFICATION APPROVAL IN RESPECT OF NEW DRUGS
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1 Legal Supplement Part B Vol. 40, No th May, LEGAL NOTICE NO. 84 REPUBLIC OF TRINIDAD AND TOBAGO THE FOOD AND DRUGS ACT, CHAP. 30:01 NOTIFICATION APPROVAL IN RESPECT OF NEW DRUGS ISSUED by the Minister of Health on the advice of the Drug Advisory Committee, in accordance with paragraph 7, Division 3 of the Second Schedule of the Food and Drugs Act. The Minister of Health signifies his approval in respect of the following new drugs: Seven Seas One-a-Day Seven Seas Health England Freely Pure Cod Liver Oil Care Ltd. Plus Vitamin E Capsules Seven Seas Pulse do. do. do. Omega 3 Pure Fish Oils Capsules Seven Seas Pulse do. do. do. High Strength Triomega Concentrated Pure Fish Oils Capsules Seven Seas Once-A-Day do. do. do. Chewable Calcium Plus Vitamin D Capsules (Choc-Mint Flavoured) Seven Seas One-A-Day do. do. do. Antioxidant Vitamins A, C & E with Selenium Capsules Seven Seas Pure do. do. do. Evening Primrose Oil Capsules 500 mg Seven Seas Pure do. do. do. Evening Primrose Oil Capsules 1000 mg Sufrexal Gel Janssen Mexico Third Schedule Farmaceutica, S.A. de C.V.
2 304 Approval in Respect of New Drugs Stocrin Capsules DuPont Costa Rica Third Schedule 500 mg Pharmaceuticals Co. USA Merck Sharp & Dohme (I.A.) Corp. Singulair Chewable Merck & Co., Inc. USA do. do. Tablets 4 mg Merck Sharp & Dohme (I.A.) Corp. Dr. Meyer s Meyer Organics Ltd. India Freely Multivitamin Sugar Coated Tablets Calcimax Tablets do. do. do. Gelacid Chewable Tablets do. do. do. Congestyl Tablets do. do. do. Colicaid Drops do. do. do. Zometa 4 mg Novartis Pharma AG Switzerland Third Schedule Lyophilisate Powder and Solvent for Solution for Infusion Braithwaite Herbal S.M. Braithwaite Trinidad and Freely Beautiful Skin Tobago Ointment ECAP 400 Capsules Glenmark India Third Schedule Pharmaceutical Ltd. Tramal 50 Injectable Albonova S.A. Ecuador do. Solution Eduador for Grunenthal Ecuatoriana C. LTDA Progon-M Capsules Promed Sunncorp Trinidad and Freely Tobago Novo-Fluoxetine Novopharm Limited Canada Third Schedule Capsules 10 mg Novo-Fluoxetine do. do. do. Capsules 20 mg Novo-Medrone do. do. do. Tablets 2.5 mg Novo-Medrone do. do. do. Tablets 5 mg
3 Approval in Respect of New Drugs 305 Novo-Medrone Novopharm Limited Canada Third Schedule Tablets 10 mg EKON D.T. Tablets Blue Cross India do. Laboratories Ltd. Meftal-Spas Tablets do. do. do. Meftal-Spas DS Tablets do. do. do. Humatrope Injection Eli Lilly and Company USA do. 5 mg (15 IU) Bactrim Suspension Produtos Roche Brazil do. 200/40 mg Quimicos e Farmaceutical S.A. Centrum Silver Adult Whitehall-Robins USA Freely Tablets with Lutein Healthcare Anzemet Injectable Gruppo Lepetit S.p.A. Italy Third Schedule Solution 100 mg/5 ml Anzemet Film-Coated Aventis USA do. Tablets 100 mg Pharmaceuticals Inc. Lantus Solution for Aventis Pharma Germany do. Injection for OptiPen Deutschland GmbH 100 IU/mL Olbetam Capsules Pharmacia & Upjohn Itay do. 250 mg S.p.A. Zyban Sustained-Release Catalytica USA do. Tablets 150 mg Pharmaceuticals Inc. USA for Glaxo Wellcome Inc. Aggrenox Capsules Boehringer Ingelheim Canada do. 200 mg/25 mg (Canada) Ltd. Jack & Jill Bedtime W.K. Buckley Limited do. Freely Liquid Children s Formula Asthalin Ecopack Cipla Ltd. India Third Schedule Inhaler 100 ug/dose Viagra Tablets 50 mg Pfizer S.A. de C.V. Mexico do. (Change of Source and Packaging) Viagra Tablets 100 mg do. do. do. (Change of Source and Packaging)
4 306 Approval in Respect of New Drugs Gyno-Travogen Ovule Schering S.p.A. Italy Third Schedule 600 mg (Change of Source) Keto Plus Shampoo Glenmark India do. Parmaceuticals Ltd. Product and Artwork Tramal 100 Injectable Albonova S.A. Ecuador do. Solution (Additional Ecuador for Source and Change of Grunenthal Artwork Ecuatoriana C. LTDA. Taxol Injection 6 mg/ml Bristol-Myers USA do. Squibb Co. Additional Indication) Tonopan Film-Coated Novartis Farma S.p.A. Italy do. Tablets (Additional Source) Serzone Tablets 50 mg Bristol-Myers Squibb USA do. Serzone Tablets 100 mg Bristol-Myers Squibb do. do. Company Serzone Tablets 150 mg do. do. do. Serzone Tablets 200 mg Bristol-Myers Squibb do. do. Serzone Tablets 250 mg do. do. do. Zerit Capsules 15 mg Squibb Puerto Rico do. (Additional Source) Manufacturing, Inc. (Subsidiary of Bristol-Myers Squibb Company USA)
5 Approval in Respect of New Drugs 307 Zerit Capsules 20 mg Squibb Puerto Rico Third Schedule (Additional Source) Manufacturing, Inc. (Subsidiary of Bristol-Myers Squibb Company USA) Zerit Capsules 30 mg do. do. do. (Additional Source) Zerit Capsules 40 mg do. do. do. (Additional Source) Sanatogen Gold A Z Roche Consumer UK Freely Tablets (Change of Health Sanatogen Kids Gold A Z do. do. do. Tablets (Change of Sanatogen Classic 50+ do. do. do. Tablets (Change of Sanatogen Multivitamins do. do. do. + Iron Tablets (Change of Packaging and Artwork Sanatogen ProNatal do. do. do. Tablets (Change of Bupivacaine Injection Pharmacia & Upjohn Australia Third Schedule BP 0.5% (Perth) Pty Limited Noristerat Injectable Schering Mexicana Mexico do. Solution (Change of S.A. de C.V. Source) Ciproxina Infusion Bayer AG Germany El Salvador do. Solution 0.1 g Corporacion Bonima S.A. de C.V.
6 308 Approval in Respect of New Drugs Ciproxina Infusion Bayer AG Germany El Salvador Third Schedule Solution 0.2 g Corporacion Bonima S.A. de C.V. Ciproxina Infusion do. do. do. Solution 0.4 g Ciproxina 50 Power and Bayer S.p.A. Italy do. do. Diluent For Oral Suspension Corporacion Bonima S.A. de C.V. Avelox Film Coated Bayer AG Germany do. do. Tablets 400 mg for Bayer de Mexico (Change on Name of S.A. de C.V. Corporacion Bonima S.A. de C.V. Stamina SX Capsules Ajanta Pharma India Freely Limited Vita Power Sulveriate Holistic Vita Power Trinidad and do. with Aloe Vera Salve Ltd. Tobago Vita Power Athletic Balm do. do. do. Vita Power Herbal Cold do. do. do. Medication Balm Healthilife Glucosamine Healthilife Ltd. UK do. Capsules 500 mg Veterinary Products RespiSure 1 One Pfizer Animal Health USA To Veterinarians or by Veterinary Prescription only Nutrival Powder Sogeval Laboratories France Freely Lobiavers Oral Solution do. do. do. Dated this 23rd day of April, PRINTED BY THE GOVERNMENT PRINTER, PORT-OF-SPAIN REPUBLIC OF TRINIDAD AND TOBAGO 2001 H. RAFEEQ Minister of Health
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