Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Arrow - Flecainide CR
Active Ingredient: Flecainide acetate 100.008mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Laboratorios Liconsa SA, Guadalajara, Spain
Product: Arrow - Flecainide CR
Active Ingredient: Flecainide acetate 200.016mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Laboratorios Liconsa SA, Guadalajara, Spain
Product: Jespect
Active Ingredient: Japanese encephalitis vaccine 6mcg/0.5mL
Dosage Form: Suspension for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturers: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Intercell Biomedical Limited, Livingston, Scotland
Product: Losartan Potassium
Active Ingredient: Losartan potassium 12.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli (U T), India
Product: Parafast
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Marksans Pharma Limited, Goa, India
Dated this 10th day of October 2012.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).