Pursuant to section 20 of the Medicines Act 1981 (“Act”), 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:
Manufacturer:
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Alprolix
Eftrenonacog alfa 250IU
Powder for infusion with diluent
Biogen NZ Biopharma Limited
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Alprolix
Eftrenonacog alfa 500IU
Powder for infusion with diluent
Biogen NZ Biopharma Limited
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Alprolix
Eftrenonacog alfa 1000IU
Powder for infusion with diluent
Biogen NZ Biopharma Limited
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany
|
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
|
Alprolix
Eftrenonacog alfa 2000IU
Powder for infusion with diluent
Biogen NZ Biopharma Limited
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany
|
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
|
Alprolix
Eftrenonacog alfa 3000IU
Powder for infusion with diluent
Biogen NZ Biopharma Limited
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany
|
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Opdivo 40mg/4mL
Nivolumab 10mg/mL
Concentrate for infusion
Bristol-Myers Squibb (NZ) Limited
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Opdivo 100mg/10mL
Nivolumab 10mg/mL
Concentrate for infusion
Bristol-Myers Squibb (NZ) Limited
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
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Dated this 6th day of April 2017.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz