Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Boostrix
Active Ingredient(s): Pertussis toxoid (adsorbed) 8µg/dose
Pertussis filamentous haemagglutinin 8µg/dose
Pertussis 69kDa outer membrane protein (Pertactin) 2.5µg/dose
Diphtheria toxoid (adsorbed) 2IU/dose
Adsorbed tetanus vaccine 20IU/dose
Dosage Form: Suspension for injection
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium
Dated this 1st day of November 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).