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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Harvoni
Ledipasvir 90mg
Sofosbuvir 400mg
Film coated tablet
Gilead Sciences (NZ)
Patheon Inc, Mississauga, Canada
Gilead Sciences Ireland UC, Carrigtohill, Ireland
Rottendorf Pharma GmbH, Ennigerloh, Germany
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Influvac Tetra
Influenza virus A/California/7/2009 (H1N1) - like strain 15mcg
Influenza virus A/Texas/50/2012 (H3N2) - like strain 15mcg
Influenza virus B/Brisbane/60/2008 - like strain 15mcg
Influenza virus B/Massachusetts/2/2012 - like strain 15mcg
Suspension for injection
Mylan New Zealand Limited
Abbott Biologicals BV, Olst, Netherlands
Abbott Biologicals BV, Weesp, Netherlands
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Product:
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Sovaldi
Sofosbuvir 400mg
Film coated tablet
Gilead Sciences (NZ)
Patheon Inc, Mississauga, Canada
Gilead Sciences Ireland UC, Carrigtohill, Ireland
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Dated this 7th day of December 2017.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz