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: Diprivan
Active Ingredient: Propofol 10mg/mL
Dosage Form: Emulsion for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca SpA, Caponago, Milan, Italy
Fresenius Kabi AB, Uppsala, Sweden
Product: Diprivan
Active Ingredient: Propofol 20mg/mL
Dosage Form: Emulsion for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca SpA, Caponago, Milan, Italy
Product: Recormon 10000 for Reco-Pen
Active Ingredient: Epoetin beta 10,000IU
Dosage Form: Front compartment Powder for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Recormon 20000 for Reco-Pen
Active Ingredient: Epoetin beta 20,000IU
Dosage Form: Front compartment Powder for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Recormon
Active Ingredient: Epoetin beta 1,000IU
Dosage Form: 0.3 mL pre-filled syringe Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 2,000IU
Dosage Form: 0.3 mL pre-filled syringe Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 3,000IU
Dosage Form: 0.3 mL pre-filled syringe Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 4,000IU
Dosage Form: 0.3 mL pre-filled syringe Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 5,000IU
Dosage Form: 0.3 mL pre-filled syringe Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 500IU
Dosage Form: 0.3 mL pre-filled syringe Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 6,000IU
Dosage Form: 0.3 mL pre-filled syringe Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Singulair
Active Ingredient: Montelukast sodium 4.16mg equivalent to 4mg montelukast free acid
Dosage Form: Chewable tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck & Co Inc, Wilson, North Carolina, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Product: Singulair
Active Ingredient: Montelukast sodium 5.2mg equivalent to 5mg montelukast free acid
Dosage Form: Chewable tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Product: Singulair
Active Ingredient: Montelukast sodium 10.4mg equivalent to 10mg montelukast free acid
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Product: Zoloft
Active Ingredient: Sertraline hydrochloride 111.9mg equivalent to 100mg sertraline
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturers: Pfizer Italiana SpA, Borgo San Michele, Latina, Italy
Pfizer Limited, Sandwich, Kent, England
Pfizer Pharmaceuticals Limited, Dalian, China
Pfizer Pty Limited, West Ryde, New South Wales, Australia
Product: Zoloft
Active Ingredient: Sertraline hydrochloride 223.8mg equivalent to 200mg sertraline
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer Consumer Healthcare Div. of Pfizer Laboratories Limited
Manufacturers: Pfizer Limited, Sandwich, Kent, England
Pfizer Pty Limited, West Ryde, New South Wales, Australia
Product: Zoloft
Active Ingredient: Sertraline hydrochloride 56mg equivalent to 50mg Sertraline
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturers: Pfizer Italiana SpA, Borgo San Michele, Latina, Italy
Pfizer Limited, Sandwich, Kent, England
Pfizer Pharmaceuticals Limited, Dalian, China
Pfizer Pty Limited, West Ryde, New South Wales, Australia
Dated this 27th day of September 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).