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: Dysport
Active Ingredient(s): Clostridium botulinum type A toxin haemagglutinin complex 500U
Dosage Form: Powder for injection
New Zealand Sponsor: New Zealand Medical & Scientific Limited
Manufacturer(s): Ispen Limited, Clwyd, United Kingdom
Product: Singulair
Active Ingredient(s): Montelukast sodium 5.2mg equivalent to 5mg montelukast free acid
Dosage Form: Chewable tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): 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(s): Montelukast sodium 10.4mg equivalent to 10mg montelukast free acid
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Product: Zocor
Active Ingredient(s): Simvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck & Co Inc, West Point, Pennsylvania, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Product: Zocor
Active Ingredient(s): Simvastatin 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck & Co Inc, West Point, Pennsylvania, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Product: Zocor
Active Ingredient(s): Simvastatin 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck & Co Inc, West Point, Pennsylvania, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Product: Zocor
Active Ingredient(s): Simvastatin 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck & Co Inc, West Point, Pennsylvania, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Product: Zocor
Active Ingredient(s): Simvastatin 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Dated this 19th day of July 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).