Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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:

ELOCTATE
Efmoroctocog alfa 250IU
Powder for infusion with diluent
Biogen NZ Biopharma Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

ELOCTATE
Efmoroctocog alfa 500IU
Powder for infusion with diluent
Biogen NZ Biopharma Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

ELOCTATE
Efmoroctocog alfa 750IU
Powder for infusion with diluent
Biogen NZ Biopharma Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

ELOCTATE
Efmoroctocog alfa 1000IU
Powder for infusion with diluent
Biogen NZ Biopharma Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

ELOCTATE
Efmoroctocog alfa 1500IU
Powder for infusion with diluent
Biogen NZ Biopharma Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

ELOCTATE
Efmoroctocog alfa 2000IU
Powder for infusion with diluent
Biogen NZ Biopharma Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

ELOCTATE
Efmoroctocog alfa 3000IU
Powder for infusion with diluent
Biogen NZ Biopharma Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Imbruvica
Ibrutinib 140mg
Capsule
Janssen-Cilag (New Zealand) Limited
Catalent CTS Inc, Missouri, United States of America

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).