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:
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
|
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
|
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).
Gazette.govt.nz