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 Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Movapo Apomorphine hydrochloride hemihydrate 10mg/mL Solution for injection CARSL Consulting Hemofarm AD, Vrsac, Serbia
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturers:
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Tamiflu Oseltamivir phosphate 39.4mg equivalent to oseltamivir 30mg Capsule Roche Products (NZ) Limited F Hoffmann-La Roche Limited, Basel, Switzerland Roche SpA, Milan, Italy DSM Pharmaceuticals Inc, North Carolina, United States of America
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Product: Active Ingredient:
Dosage Form: New Zealand Sponsor: Manufacturer:
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Tamiflu Oseltamivir phosphate 39.4mg/g equivalent to oseltamivir 6mg/mL when reconstituted with 55mL of water Powder for oral suspension Roche Products (NZ) Limited Rottendorf Pharma GmbH, Ennigerloh, Germany
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturers:
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Tamiflu Oseltamivir phosphate 59.1mg equivalent to oseltamivir 45mg Capsule Roche Products (NZ) Limited F Hoffmann-La Roche Limited, Basel, Switzerland Roche SpA, Milan, Italy DSM Pharmaceuticals Inc, North Carolina, United States of America
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturers:
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Tamiflu Oseltamivir phosphate 98.5mg equivalent to oseltamivir 75mg Capsule Roche Products (NZ) Limited Cenexi SAS, Fontenay-sous-Bois, France Catalent Germany Schorndorf GmbH, Schorndorf, Germany Roche SpA, Milan, Italy
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Dated this 18th day of March 2016.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).