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
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Hiberix
Haemophilus influenzae vaccine, tetanus toxoid conjugate 10mcg
Powder for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals SA, Wavre, Belgium
GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France
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Product:
Component 1:
Active Ingredients:
Dosage Form:
Component 2:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Infanrix-IPV+Hib
Detoxified pertussis toxin 25mcg
Diphtheria toxoid, adsorbed 30IU
Pertactin 8mcg
Pertussis filamentous haemagglutinin 25mcg
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid, adsorbed 40IU
Suspension for injection
Haemophilus influenzae vaccine, tetanus toxoid conjugate 10mcg
Powder for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals SA, Wavre, Belgium
GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France
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Dated this 14th day of February 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz