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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Cerezyme
Imiglucerase 400U
Powder for infusion
sanofi-aventis new zealand limited
Genzyme Ireland Limited, Waterford, Ireland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Curosurf
Poractant Alfa 80mg/mL
Suspension for injection
Douglas Pharmaceuticals Limited
Chiesi Farmaceutici SpA, Parma, Italy
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Praluent
Alirocumab 75mg/mL
Solution for injection
sanofi-aventis new zealand limited
Sanofi Winthrop Industrie, Le Trait, France
Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Praluent
Alirocumab 150mg/mL
Solution for injection
sanofi-aventis new zealand limited
Sanofi Winthrop Industrie, Le Trait, France
Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Ultibro Breezhaler 110/50
Glycopyrronium bromide 63mcg equivalent to glycopyrronium 50mcg
Indacaterol maleate 143mcg equivalent to indacaterol 110mcg
Powder filled inhalation capsule
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
Novartis Pharma Schweizerhalle AG, Schweizerhalle, Switzerland
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Dated this 24th day of May 2018.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz