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 was referred 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-hexa (Combination Product)
Active Ingredients: Diphtheria toxoid, adsorbed 30IU/dose
Hepatitis B surface antigen, recombinant 10µg/dose
Pertactin 8µg/dose
Pertussis filamentous haemagglutinin 25µg/dose
Pertussis toxoid, adsorbed 25µg/dose
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid, adsorbed 40IU/dose
Dosage Form: Suspension for injection
Manufacturer: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
Active Ingredient: Haemophilus influenzae type b vaccine 10µg/dose
Dosage Form: Powder for injection
Manufacturer: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Dated this 23rd day of August 2007.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).