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: Flexetor
Active Ingredient: Fluoxetine hydrochloride 22.36mg equivalent to 20 mg fluoxetine
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Rolab Limited, Spartan, Kempton Park, South Africa
Rottendorf Pharma Pty Limited, Enningerloh, Germany
Product: Fludara oral
Active Ingredient: Fludarabine phosphate 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Schering (NZ) Limited
Manufacturer: Schering AG, Wedding, Berlin, Germany
Product: Ismo 20
Active Ingredient: Isosorbide mononitrate 20mg
Dosage Form: (VO3) Tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Dated this 6th day of April 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).