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: Engerix-B vaccine
Active Ingredient(s): Hepatitis B surface antigen (recombinant) 20µg/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium
Product: Infanrix-HepB
Active Ingredient(s): Tetanus toxoid 80IU/mL
Hepatitis B surface antigen (recombinant) 20µg/mL
Diphtheria toxoid (adsorbed) 60IU/mL
Detoxified pertussis toxin 50µg/mL
Pertussis filamentous haemagglutinin 50µg/mL
Pertactin 16µg/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium
Product: Twinrix Adult
Active Ingredient(s): Hepatitis A vaccine 720EU/mL
Hepatitis B surface antigen (recombinant) 20µg/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium
Product: Twinrix Junior
Active Ingredient(s): Hepatitis A vaccine 720EU/mL
Hepatitis B surface antigen (recombinant) 20µg/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium

Dated this 10th day of July 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).