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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Firazyr
Icatibant 10mg/mL
Solution for injection
Shire New Zealand Limited
Rentschler Biotechnologie GmbH, Laupheim, Germany
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Spiolto Respimat
Olodaterol hydrochloride 0.0248% w/v
equivalent to Olodaterol 2.5mcg per actuation
Tiotropium bromide monohydrate 0.0283% w/v
equivalent to Tiotropium 2.5mcg per actuation
Solution for inhalation
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
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Dated this 20th day of November 2015.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz