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: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturers:
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Boostrix-IPV Diphtheria toxoid, adsorbed 2.5Lf U 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 5Lf U Suspension for injection GlaxoSmithKline (NZ) Limited GlaxoSmithKline Biologicals SA, Rixensart, Belgium GlaxoSmithKline Biologicals (Saint-Amand-Les-Eaux), Saint-Amand-Les-Eaux, France
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Product: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturers:
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Harvoni Ledipasvir 90mg Sofosbuvir 400mg Film coated tablet Gilead Sciences (NZ) Patheon Inc, Mississauga, Canada Gilead Sciences Ireland UC, Carrigtohill, Ireland
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Dated this 19th day of May 2016.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).