Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which wasreferred to the Minister of Health under the provisions of section 24 (5) of the Act and is set out in the Schedule hereto:
Schedule
Product: Infanrix-IPV-Hib
Active Ingredient(s): Polio virus type 1 80DAgU/mL
Detoxified pertussis toxin 50µg/mL
Pertussis 69kDa outer membrane protein 16µg/mL
Diphtheria toxoid (adsorbed) 60IU/mL
Polio virus type 2 16DAgU/mL
Polio virus type 3 64DAgU/mL
Adsorbed tetanus vaccine 80IU/mL
Pertussis filamentous haemagglutinin 50µg/mL
Dosage Form: Suspension for injection
Active Ingredient(s): Haemophilus influenzae vaccine (tetanus toxoid conjugate) 20µg/mL
Dosage Form: Powder for injection
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium
Dated this 18th day of August 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).