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: Papaverine Hydrochloride
Active Ingredient: Papaverine hydrochloride 12mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Mayne Pharma Pty Limited
Manufacturer: Mayne Pharma Pty Limited, Mulgrave North, Victoria, Australia
Product: Papaverine hydrochloride
Active Ingredient: Papaverine hydrochloride 30mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Mayne Pharma Pty Limited
Manufacturer: Mayne Pharma Pty Limited, Mulgrave North, Victoria, Australia
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 & Co Inc, Wilson, North Carolina, 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: 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 & Co Inc, Wilson, North Carolina, 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
Dated this 18th day of March 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).