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: Vioxx
Active Ingredient(s): Rofecoxib 2.5mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck & Co Inc, Merck Manufacturing Division, West Point, Pennsylvania, United States of America
Product: Vioxx
Active Ingredient(s): Rofecoxib 5mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck & Co Inc, Merck Manufacturing Division, West Point, Pennsylvania, United States of America
Product: Vioxx
Active Ingredient(s): Rofecoxib 12.5mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck Manufacturing Division of Merck and Co, Bo. Sabana Hoyos, Arecibo, Puerto Rico
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Product: Vioxx
Active Ingredient(s): Rofecoxib 25mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck Manufacturing Division of Merck and Co, Bo. Sabana Hoyos, Arecibo, Puerto Rico
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Dated this 10th day of October 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).