Notice Type
Departmental
Notice Title

Consent to the Distribution of Changed Medicines

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: Advantan
Active Ingredient(s): Methylprednisolone aceponate 0.1%
Dosage Form: Topical ointment
New Zealand Sponsor: CSL (New Zealand) Limited
Manufacturer(s): Schering AG, Wedding Plant, Berlin, Germany
Schering SpA, Segrate, Milano, Italy
Product: Comvax
Active Ingredient(s): Haemophilus type b conjugate vaccine (N.meningitidis group B OMP conjugate) 7.5µg
Hepatitis B vaccine (rDNA) 5µg
Dosage Form: Suspension for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck & Co Inc, West Point, Pennsylvania, United States of America
Product: Pedvax HIB
Active Ingredient(s): Haemophilus type b conjugate vaccine (N.meningitidis group B OMP conjugate) 7.5µg
Neisseria meningitidis vaccine 125µg
Dosage Form: Suspension for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck & Co Inc, West Point, Pennsylvania, United States of America
Product: Taxotere
Active Ingredient(s): Docetaxel (trihydrate) 40mg/mL
Dosage Form: Solution for Concentrate for infusion
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer(s): Rhone-Poulenc Rorer Limited, Dagenham, Essex, United Kingdom
Rhone-Poulenc Rorer SA, Vitry sur Seine, France
Note: This product has provisional consent.
Dated this 22nd day of September 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).