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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Copaxone Glatiramer acetate 20mg Solution for injection Seqirus (NZ) Limited Teva Pharmaceutical Industries Limited, Kfar Saba, Israel IVAX Pharmaceuticals UK Limited, Runcorn, United Kingdom
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturers:
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ELOCTATE Efmoroctocog alfa 250IU Powder for infusion with diluent Bioverativ NZ Limited Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany 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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ELOCTATE Efmoroctocog alfa 500IU Powder for infusion with diluent Bioverativ NZ Limited Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany 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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ELOCTATE Efmoroctocog alfa 750IU Powder for infusion with diluent Bioverativ NZ Limited Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany 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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ELOCTATE Efmoroctocog alfa 1000IU
Powder for infusion with diluent Bioverativ NZ Limited Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany 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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ELOCTATE Efmoroctocog alfa 1500IU Powder for infusion with diluent Bioverativ NZ Limited Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany 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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ELOCTATE Efmoroctocog alfa 2000IU Powder for infusion with diluent Bioverativ NZ Limited Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany 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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ELOCTATE Efmoroctocog alfa 3000IU Powder for infusion with diluent Bioverativ NZ Limited Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
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Dated this 22nd day of January 2018.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on the 11th day of September 2013).