✨ Medicines Notifications
NEW ZEALAND GAZETTE
No. 11
Product:
Infanrix-hexa (Combination Product)
Component One:
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, Rixensart, Belgium
Component Two:
Active Ingredient:
Haemophilus influenzae type b vaccine 10µg/dose
Dosage Form:
Powder for injection
New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited
Manufacturer:
GlaxoSmithKline Biologicals, Rixensart, Belgium
Product:
Infanrix-Hib vaccine (Combination Product)
Component One:
Active Ingredients:
Detoxified pertussis toxin 25µg
Diphtheria toxoid, adsorbed 30IU
Pertactin 8µg
Pertussis filamentous haemagglutinin 25µg
Tetanus toxoid 40IU
Dosage Form:
Suspension for injection
Component Two:
Active Ingredient:
Haemophilus influenzae vaccine, tetanus toxoid conjugate 10µg
Dosage Form:
Powder for injection
New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited
Manufacturer:
GlaxoSmithKline Biologicals, Rixensart, Belgium
Product:
Infanrix-IPV (notification received 4 August 2003)
Active Ingredients:
Detoxified pertussis toxin 50µg/mL
Diphtheria toxoid, adsorbed 60IU/mL
Pertactin 16µg/mL
Pertussis filamentous haemagglutinin 50µg/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
New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited
Manufacturer:
GlaxoSmithKline Biologicals, Rixensart, Belgium
Product:
Infanrix-IPV (notification received 6 August 2003)
Active Ingredients:
Detoxified pertussis toxin 50µg/mL
Diphtheria toxoid, adsorbed 60IU/mL
Pertactin 16µg/mL
Pertussis filamentous haemagglutinin 50µg/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
New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited
Manufacturer:
GlaxoSmithKline Biologicals, Rixensart, Belgium
Product:
Infanrix-IPV-Hib (Combination Product) (notification received 4 August 2003)
Component One:
Active Ingredients:
Detoxified pertussis toxin 50µg/mL
Diphtheria toxoid, adsorbed 60IU/mL
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Online Sources for this page:
VUW Te Waharoa —
NZ Gazette 2004, No 11
Gazette.govt.nz —
NZ Gazette 2004, No 11
✨ LLM interpretation of page content
🏥
Consent to the Distribution of Changed Medicines
(continued from previous page)
🏥 Health & Social Welfare2 February 2004
Medicines Act 1981, Distribution, Changed Medicines, Infanrix-hexa, Infanrix-Hib, Infanrix-IPV, Infanrix-IPV-Hib