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 set out in the Schedule hereto:
Schedule
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Bisoprolol Actavis
Bisoprolol fumarate 2.5mg
Tablet
Actavis New Zealand Limited
Niche Generics Limited, Dublin, Ireland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Bisoprolol Actavis
Bisoprolol fumarate 5mg
Tablet
Actavis New Zealand Limited
Niche Generics Limited, Dublin, Ireland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Bisoprolol Actavis
Bisoprolol fumarate 10mg
Tablet
Actavis New Zealand Limited
Niche Generics Limited, Dublin, Ireland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Hizentra
Normal immunoglobulin 200mg/mL
Solution for injection
CSL Behring (NZ) Limited
CSL Behring AG, Bern, Switzerland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Incruse Ellipta
Umeclidinium bromide 74.2mcg equivalent to umeclidinium 62.5mcg
Powder for inhalation
GlaxoSmithKline (NZ) Limited
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Hertfordshire, United Kingdom
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Dated this 13th day of February 2015.
SARAH READER, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz