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: Manufacturers:
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Xyntha Moroctocog alfa 250IU equivalent to 23mcg Powder for injection Pfizer New Zealand Limited Wyeth Farma SA, Madrid, Spain Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturers:
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Xyntha Moroctocog alfa 500IU equivalent to 45mcg Powder for injection Pfizer New Zealand Limited Wyeth Farma SA, Madrid, Spain Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturers:
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Xyntha Moroctocog alfa 1000IU equivalent to 90mcg Powder for injection Pfizer New Zealand Limited Wyeth Farma SA, Madrid, Spain Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturers:
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Xyntha Moroctocog alfa 2000IU equivalent to 180mcg Powder for injection Pfizer New Zealand Limited Wyeth Farma SA, Madrid, Spain Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Xyntha Moroctocog alfa 3000IU Powder for injection Pfizer New Zealand Limited Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
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Dated this 26th 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).