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: Ervevax vaccine
Active Ingredient(s): Rubella virus (Wistar RA27/3 strain) 1,000TCID50
Dosage Form: Powder for injection
NZ Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium
Product: Priorix
Active Ingredient(s): Rubella virus (Wistar RA27/3 strain) 1,000CCID50
Measles vaccine (Schwarz strain) 1,000CCID50
Mumps virus, live attenuated (RIT 4385) 5,012CCID50
Dosage Form: Powder for injection
NZ Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): Sachsisches Serumwerk Dresden, Branch of SKB Pharma GmbH, Dresden, Germany
SmithKline Beecham Biologicals SA, Rixensart, Belgium
SmithKline Beecham Biologicals SA, Genval, Belgium
Product: Rimevax
Active Ingredient(s): Measles vaccine (Schwarz strain) 1,000TCID50
Dosage Form: Powder for injection
NZ Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium
Dated this 12th day of January 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).