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:
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Fluarix Tetra
Influenza virus A/California/7/2009 (H1N1) – like strain 15mcg
Influenza virus A/Texas/50/2012 (H3N2) – like strain 15mcg
Influenza virus B/Massachusetts/2/2012 – like strain 15mcg
Influenza virus B/Yamagata 16/88 – like strain 15mcg
Suspension for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals (Dresden), Dresden, Germany
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Product:
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Opdivo 40mg/4mL
Nivolumab 10mg/mL
Concentrate for infusion
Bristol-Myers Squibb (NZ) Limited
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
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Product:
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New Zealand Sponsor:
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Opdivo 100mg/10mL
Nivolumab 10mg/mL
Concentrate for infusion
Bristol-Myers Squibb (NZ) Limited
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
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Product:
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New Zealand Sponsor:
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Prolia
Denosumab 60mg/mL
Solution for injection
Amgen New Zealand Limited
Amgen Manufacturing Limited, Juncos, Puerto Rico
Amgen Technology (Ireland) Unlimited Company, Dun Laoghaire, Ireland
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Dated this 19th day of December 2017.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz