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



Next Page →



Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2004, No 11


Gazette.govt.nz PDF NZ Gazette 2004, No 11





✨ LLM interpretation of page content

🏥 Consent to the Distribution of Changed Medicines (continued from previous page)

🏥 Health & Social Welfare
2 February 2004
Medicines Act 1981, Distribution, Changed Medicines, Infanrix-hexa, Infanrix-Hib, Infanrix-IPV, Infanrix-IPV-Hib