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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Champix Varenicline tartrate 0.85mg equivalent to varenicline 0.5mg Film coated tablet Pfizer New Zealand Limited R-Pharm Germany GmbH, Illertissen, Germany
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Champix Varenicline tartrate 1.71mg equivalent to varenicline 1mg Film coated tablet Pfizer New Zealand Limited R-Pharm Germany GmbH, Illertissen, Germany
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Product: Active Ingredient: Dosage Form: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturers:
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Champix 0.5mg and 1mg tablets (Combination Product) Varenicline tartrate 0.85mg equivalent to varenicline 0.5mg Film coated tablet Varenicline tartrate 1.71mg equivalent to varenicline 1mg Film coated tablet Pfizer New Zealand Limited R-Pharm Germany GmbH, Illertissen, Germany
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Product: Active Ingredient:
Dosage Form: New Zealand Sponsor: Manufacturer:
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Creon 10,000 Pancreatin 150mg equivalent to amylase 8,000 Ph Eur U, lipase 10,000 Ph Eur U, total protease 600 Ph Eur U Modified release capsule BGP Products Abbott Laboratories GmbH, Neustadt, Germany
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Product: Active Ingredient:
Dosage Form: New Zealand Sponsor: Manufacturer:
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Creon 25,000 Pancreatin 300mg equivalent to amylase 18,000 Ph Eur U, lipase 25,000 Ph Eur U, total protease 1,000 Ph Eur U Modified release capsule BGP Products Abbott Laboratories GmbH, Neustadt, Germany
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Product: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturers:
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Truvada Emtricitabine 200mg Tenofovir disoproxil fumarate 300mg equivalent to tenofovir disoproxil 245mg Tablet Gilead Sciences (NZ) Patheon Inc, Mississauga, Canada Patheon Inc, Whitby, Canada Takeda GmbH, Oranienburg, Germany Gilead Sciences Ireland UC, County Cork, Ireland Rottendorf Pharma GmbH, Ennigerloh, Germany
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Dated this 20th day of January 2017.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).