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).

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