Legal Supplement Part B Vol. 57, No. 6 18th January, NOTIFICATION NOTICE OF APPROVAL IN RESPECT OF NEW DRUGS
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1 Legal Supplement Part B Vol. 57, No. 6 18th January, LEGAL NOTICE NO. 5 REPUBLIC OF TRINIDAD AND TOBAGO FOOD AND DRUGS ACT, CHAP. 30:01 NOTIFICATION NOTICE OF APPROVAL IN RESPECT OF NEW DRUGS ISSUED by the Minister on the recommendation of the Drug Advisory Committee in accordance with paragraph 7, Division 3 of the Second Schedule of the Food and Drugs Regulations. The Minister signifies his approval in respect of the following new drugs: Novolin N PenFill Suspension for Injection 100 IU/ml, 3 ml Cartridge (Change of Package Novo Nordisk A/S Denmark Novolin N Suspension for Injection 100 IU/ml, 10 ml Vial (Change of Package NovoMix 30 FlexPen 100 IU/ml, 3 ml Pre-Filled Pen Suspension for Injection Design and Update to Package NovoRapid Flex Pen 3ml Pre-filled Pen 100lU/ml, Solution for Injection (Update to Packaging Bisolvon Cough with Mucus Tablets 8 mg Design, Primary Packaging, Formulation, Source and Trade Name) Delpharm Reims Combivir Film-Coated Tablets 150/300 mg (Additional Manufacturing Pharmaceuticals SA Poland
2 12 Approval in Respect of New Drugs HAVRIX Junior 720 (Suspension for Injection) (Change of Formulation) Biologicals S.A. Belgium HAVRIX 1440 (Suspension for Injection) (Change of Formulation) Sandimmun Neoral Capsules 25 mg (Change of Source) Catalent Eberbach GmbH, Novartis Pharma Stein AG, For Novartis Pharma AG Basle, Sandimmun Neoral Capsules 100 mg (Change of Source) Pantecta P20 Tablets (Change of Name of Manufacturer and Change of Name of Packager) Takeda GmbH Takeda Mexico S.A. De C.V. Mexico for Novartis Farmaceutica S.A., (AC) Guatemala Mexico Pantecta 40 mg Tablets Manufacturer and Change of Name of Packager) Pantecta IV Lyophilized Powder for Solution for Injection 40 mg Manufacturer and Change of Name of Packager) Otrivin Nasal Drops Solution 0.1% Adults Design of Primary and Secondary Packaging) Novartis Consumer Health S.A. Otrivin Metered Dose Nasal Spray 0.1% Adults Design of Primary and Secondary Packaging)
3 Approval in Respect of New Drugs 13 Otrivin Nasal Spray Nebuliser Solution 0.1%-Adults Design of Primary and Secondary Packaging) Novartis Consumer Health S.A. Otrivin Nasal Gel 0.1% Adults Design of Primary and Secondary Packaging) Otrivin Nasal Drops Solution 0.05% - Children Design of Primary and Secondary Packaging) Otrivin Metered Dose Nasal Spray 0.05% Children Design of Primary and Secondary Packaging) Byetta 5 mcg/dose Solution for Injection Prefilled Pen (Change of Packaging Site and New Indication) Byetta 10 mcg/dose Solution for Injection Pre-filled Pen (Change of Packaging Site and New Indication) Epilim 200 Gastro-Resistant Tablets Epilim Chrono 200 Controlled Release Tablets Epilim Chrono 300 Controlled Release Tablets Manufactured for: Baxter Pharmaceutical Solutions LLC Packed by: Enestia Belgium Pen Assembly by: Sharp Corporation Holder: AstraZeneca Camcar S.A. Panama Belgium Sanofi-Aventis, S.A. Sanofi Winthrop Industrie Spain
4 14 Approval in Respect of New Drugs Epilim Chrono 500 Controlled Release Tablets Sanofi Winthrop Industrie Norvasc Tablets 5 mg R-Pharm GmbH Norvasc Tablets 10 mg Vfend Film Coated Tablets 200 mg Packager and New Indication) Pfizer ltalia S.r.l. Italy R-Pharm GmbH Vfend Powder for Solution for Infusion 200 mg Packager and New Indication) Pharmacia & Upjohn Co. Fareva Amboise Ponstan Capsules 250 mg Pfizer Manufacturing Deutschland GmbH Ponstan Forte Film Coated Tablets 500 mg Diflucan Capsules 150 mg Fareva Amboise License Holder: Pfizer Holding Celebrex Capsules 200 mg Neolpharma Inc. Puerto Rico, R-Pharm GmbH Glynase Prestab Tablets 3 mg Neolpharma Inc.
5 Approval in Respect of New Drugs 15 Glynase Prestab Tablets 6 mg Neolpharma Inc. Pharmacia & Upjohn Company Cytotec 200 mcg Tablets (Change of Source and Piramal Healthcare UK Limited UK Claritine 10 mg Tablets (Change of Marketing Authorization Holder and Manufactured & Schering-Plough Labo NV For: Bayer S.A., Guatemala Belgium Claritine Syrup (Alcohol Free) 1 mg/ml (Change of Marketing Authorization Holder and Angeliq Film Coated Tablets 2 mg/1 mg Marketing Authorization Holder, Change of Bayer Weimar GmbH und Co. KG Schering do Brasil, Quimica e Farmaceutica Ltda. For: Bayer Pharma AG, Brazil Redoxon Vitamin C 2g Effervescent Tablets Lemon Flavor Manufacturer and Change of Primary & Secondary Artwork Delpharm For: Bayer S.A. Guatemala AriXtra Solution for Injection Pre-Filled Syringe with an Automatic Safety System 2.5 mg/0.5ml Marketing Authorization Holder, Change of Manufactured & Aspen Notre Dame de Bondeville For: Aspen Labs S.A. De C.V. Mexico
6 16 Approval in Respect of New Drugs Tums Extra Strength 750 mg Chewable Antacid Tablets Assorted Fruit Consumer Healthcare Distributor: Consumer Healthcare Ketozal Shampoo Design and Change of Primary Packaging) Carlisle Laboratories Limited Barbados Myleran Film-Coated Tablets 2 mg Manufacturer) Excella GmbH Puri-nethol Tablets 50 mg Manufacturer) lmuran Tablets 50 mg Manufacturer) Liquiband Optima/Tropical Skin Adhesive 0.5 g (Change of Packaging) Advanced Medical Solutions (Plymouth) Limited United Kingdom (Pharmacy ONLY) Picoprep Powder For Oral Solution/Sachet 10 mg, 3.5 g, 12 g Ferring Pharmaceuticals (China) Co. Ltd. China Pentasa Suppositories 1 g Ferring International Center S.A. Dated this 10th day of January, 2018 T. DEYALSINGH Minister of Health PRINTED BY THE GOVERNMENT PRINTER, CARONI REPUBLIC OF TRINIDAD AND TOBAGO 2018
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