Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Acular
Active Ingredient(s): Ketorolac tromethamine 5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer(s): Allergan Pharmaceuticals (Ireland) Limited, Westport, County Mayo, Ireland
Product: Dilatrend
Active Ingredient(s): Carvedilol 12.5mg
Dosage Form: Tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Roche Diagnostics GmbH, Mannheim, Germany
Product: Dilatrend
Active Ingredient(s): Carvedilol 25mg
Dosage Form: Tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Roche Diagnostics GmbH, Mannheim, Germany
Product: Dilatrend
Active Ingredient(s): Carvedilol 3.12mg
Dosage Form: Tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Roche Diagnostics GmbH, Mannheim, Germany
Product: Dilatrend
Active Ingredient(s): Carvedilol 6.25mg
Dosage Form: Tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Roche Diagnostics GmbH, Mannheim, Germany
Product: Femara
Active Ingredient(s): Letrozole 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland
Product: Zoloft
Active Ingredient(s): Sertraline hydrochloride 111.9mg equivalent to 100 mg sertraline
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Pfizer Italiana SpA, Borgo San Michele, Latina, Italy
Pfizer Limited, Sandwich, Kent, England
Pfizer Pty Limited, West Ryde, New South Wales, Australia
Product: Zoloft
Active Ingredient(s): Sertraline hydrochloride 223.8mg equivalent to 200 mg sertraline
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Pfizer Limited, Sandwich, Kent, England
Pfizer Pty Limited, West Ryde, New South Wales, Australia
Product: Zoloft
Active Ingredient(s): Sertraline hydrochloride 56mg equivalent to 50mg Sertraline
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Pfizer Italiana SpA, Borgo San Michele, Latina, Italy
Pfizer Limited, Sandwich, Kent, England
Pfizer Pty Limited, West Ryde, New South Wales, Australia
Dated this 22nd day of August 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).