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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ELOCTATE Efmoroctocog alfa 250IU Powder for infusion with diluent Biogen NZ Biopharma Limited 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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ELOCTATE Efmoroctocog alfa 500IU Powder for infusion with diluent Biogen NZ Biopharma Limited 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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ELOCTATE Efmoroctocog alfa 750IU Powder for infusion with diluent Biogen NZ Biopharma Limited 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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ELOCTATE Efmoroctocog alfa 1000IU Powder for infusion with diluent Biogen NZ Biopharma Limited 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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ELOCTATE Efmoroctocog alfa 1500IU Powder for infusion with diluent Biogen NZ Biopharma Limited 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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ELOCTATE Efmoroctocog alfa 2000IU Powder for infusion with diluent Biogen NZ Biopharma Limited 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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ELOCTATE Efmoroctocog alfa 3000IU Powder for infusion with diluent Biogen NZ Biopharma Limited 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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Imbruvica Ibrutinib 140mg Capsule Janssen-Cilag (New Zealand) Limited Catalent CTS Inc, Missouri, United States of America
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Dated this 19th day of December 2016.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).