Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new 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: Boostrix
Active Ingredients: Diphtheria toxoid, adsorbed 2IU
Pertactin 2.5mcg
Pertussis filamentous haemagglutinin 8mcg
Pertussis toxoid, adsorbed 8mcg
Tetanus toxoid, adsorbed 20IU
Dosage Form: Suspension for injection
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France
   
Product: Boostrix-IPV
Active Ingredients: Diphtheria toxoid, adsorbed 2IU
Pertactin 2.5mcg
Pertussis filamentous haemagglutinin 8mcg
Pertussis toxoid, adsorbed 8mcg
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid 20IU
Dosage Form: Suspension for injection
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France
   
Product: Infanrix
Active Ingredients: Diphtheria toxoid, adsorbed 30IU
Pertactin 8mcg
Pertussis filamentous haemagglutinin 25mcg
Pertussis toxoid, adsorbed 25mcg
Tetanus toxoid, adsorbed 40IU
Dosage Form: Vaccine Suspension for injection
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturer: GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France
   
Product: Infanrix-hexa
Component 1:  
Active Ingredients: Diphtheria toxoid, adsorbed 30IU
Hepatitis B surface antigen, recombinant 10mcg
Pertactin 8mcg
Pertussis filamentous haemagglutinin 25mcg
Pertussis toxoid, adsorbed 25mcg
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid, adsorbed 40IU
Dosage Form: Suspension for injection
Component 2:  
Active Ingredient: Haemophilus influenzae vaccine, tetanus toxoid conjugate 10mcg
Dosage Form: Powder for injection
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Wavre, Belgium
GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France
   
Product: Infanrix-IPV
Active Ingredients: Diphtheria toxoid, adsorbed 60IU/mL
Pertactin 16mcg/mL
Pertussis filamentous haemagglutinin 50mcg/mL
Pertussis toxoid, adsorbed 50mcg/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 (France), Saint-Amand-Les-Eaux, France
   
Product: Infanrix-IPV+Hib
Component 1:  
Active Ingredients: Diphtheria toxoid, adsorbed 30IU
Pertactin 8mcg
Pertussis filamentous haemagglutinin 25mcg
Pertussis toxoid, adsorbed 25mcg
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid, adsorbed 40IU
Dosage Form: Suspension for injection
Component 2:  
Active Ingredient: Haemophilus influenzae vaccine, tetanus toxoid conjugate 10mcg
Dosage Form: Powder for injection
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Wavre, Belgium
GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France
   
Product: MYLOTARG
Active Ingredient: Gemtuzumab ozogamicin 5mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Wyeth Pharmaceutical Division of Wyeth Holdings LLC, New York, United States of America


Dated this 18th day of November 2022.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).