β¨ Medicines Distribution Consent
NEW ZEALAND GAZETTE, No. 39 β 13 APRIL 2017
Consent to the Distribution of New Medicines
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
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Alprolix
Eftrenonacog alfa 250IU
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 500IU
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 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:
Opdivo 40mg/4mL
Nivolumab 10mg/mL
Concentrate for infusion
Bristol-Myers Squibb (NZ) Limited
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Opdivo 100mg/10mL
Nivolumab 10mg/mL
Concentrate for infusion
Bristol-Myers Squibb (NZ) Limited
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
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).
2017-go1748
Consent to the Distribution of a New Medicine
Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
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β¨ LLM interpretation of page content
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social Welfare6 April 2017
Medicines, Distribution, Consent, Medicines Act 1981
- CHRIS JAMES, Group Manager, Medsafe, Ministry of Health
π₯ Consent to the Distribution of a New Medicine
π₯ Health & Social WelfareMedicine, Distribution, Consent, Medicines Act 1981
NZ Gazette 2017, No 39