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: Hiberix
Active Ingredient: Haemophilus influenzae vaccine, tetanus toxoid conjugate 10Ág/dose
Dosage Form: Powder for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals, Rixensart, Belgium
Product: Infanrix-Hib vaccine
Component One (syringe):
Active Ingredients: Detoxified pertussis toxin 25Ág
Diphtheria toxoid, adsorbed 30IU
Pertactin 8Ág
Pertussis filamentous haemagglutinin 25Ág
Tetanus toxoid 40IU
Dosage Form: Suspension for injection
Component Two(vial):
Active Ingredient: Haemophilus influenzae vaccine, tetanus toxoid conjugate 10Ág
Dosage Form: Powder for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals, Rixensart, Belgium
Product: Infanrix-IPV-Hib (Combination Product)
Component One (syringe):
Active Ingredients: Detoxified pertussis toxin 50Ág/mL
Diphtheria toxoid, adsorbed 60IU/mL
Pertactin 16Ág/mL
Pertussis filamentous haemagglutinin 50Ág/mL
Polio virus type 1 80DAgU/mL
Polio virus type 2 16DAgU/mL
Polio virus type 3 64DAgU/mL
Tetanus toxoid, adsorbed 80IU/mL
Dosage Form: Suspension for injection
Manufacturer: GlaxoSmithKline Biologicals, Rixensart, Belgium
Component Two(vial):
Active Ingredient: Haemophilus influenzae vaccine, tetanus toxoid conjugate 20Ág/mL
Dosage Form: Powder for injection
Manufacturer: GlaxoSmithKline Biologicals, Rixensart, Belgium
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Product: Tritanrix-HB+Hib
Component One(vial):
Active Ingredients: Bordetella pertussis, inactivated 4IU/mL
Diphtheria toxoid, adsorbed 60IU/mL
Hepatitis B vaccine, rDNA 20Ág/mL
Tetanus toxoid 120IU/mL
Dosage Form: Suspension for injection
Component Two(vial):
Active Ingredient: Haemophilus influenzae vaccine, tetanus toxoid conjugate 20Ág/mL
Dosage Form: Powder for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals, Rixensart, Belgium
Dated this 14th day of January 2004.
CYNTHIA MALING, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).