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: Twinrix Junior
Active Ingredient(s): Hepatitis A vaccine 720EU/mL
Hepatitis B surface antigen (recombinant) 20Ág/mL
Dosage Form: 0.5mL Suspension for injection
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
Product: Twinrix
Active Ingredient(s): Hepatitis A vaccine 720EU/mL
Hepatitis B surface antigen (recombinant) 20Ág/mL
Dosage Form: 1mL Suspension for injection
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
Dated this 23rd day of January 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).