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: Fluarix
Active Ingredient(s): Influenza virus haemagglutinin type A/Beijing/262/95-like (H1N1) 30µg/mL
Influenza virus haemagglutinin type A/Sydney/5/97-like (H3N2) 30µg/mL
Influenza virus haemagglutinin type B/Beijing/184/93-like 30µg/mL
Dosage Form: Suspension 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
Dated this 21st 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.