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 Ingredients:



Dosage Form:
New Zealand Sponsor:
Manufacturer:

Afluria Quad
Influenza virus A/Hong Kong/4801/2014 (H3N2) - like strain 15mcg
Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15mcg
Influenza virus B/Brisbane/60/2008 - like strain 15mcg
Influenza virus B/Phuket/3073/2013 - like strain 15mcg
Suspension for injection
Seqirus (NZ) Limited
Seqirus Pty Limited, Melbourne, Australia

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

Alprolix
Eftrenonacog alfa 250IU
Powder for infusion with diluent
Bioverativ NZ 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
Bioverativ NZ 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
Bioverativ NZ 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
Bioverativ NZ 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
Bioverativ NZ Limited
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

Product:
Active Ingredients:








Dosage Form:
New Zealand Sponsor:
Manufacturers:

Hexaxim
Diphtheria toxoid, adsorbed 30Lf U equivalent to not less than 20IU
Haemophilus influenzae type b polysaccharide 12mcg
Hepatitis B virus surface antigen 10mcg
Pertussis filamentous haemagglutinin 25mcg
Pertussis toxoid, adsorbed 25mcg
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid, adsorbed 10Lf U equivalent to not less than 40IU
Suspension for injection
Sanofi-Aventis New Zealand Limited
Sanofi Pasteur SA, Marcy L'Etoile, France
Sanofi Pasteur SA, Val-De-Reuil Cedex, France

Dated this 8th day of March 2018.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).