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 set out in the Schedule hereto:

Schedule

Product:
Active Ingredients:



Dosage Form:
New Zealand Sponsor:
Manufacturers:

Fluarix Tetra
Influenza virus A/California/7/2009 (H1N1) like strain 15mcg
Influenza virus A/Texas/50/2012 (H3N2) like strain 15mcg
Influenza virus B/Massachusetts/2/2012 like strain 15mcg
Influenza virus B/Yamagata 16/88 15mcg
Suspension for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals SA, Wavre, Belgium
GlaxoSmithKline Biologicals (Dresden), Dresden, Germany

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

Gazyva
Obinutuzumab 1000mg
Concentrate for infusion
Roche Products (NZ) Limited
Roche Diagnostics GmbH, Mannheim, Germany

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

Risperidone ODT Mylan
Risperidone 0.5mg
Orodispersible tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Maharashtra State, India

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

Risperidone ODT Mylan
Risperidone 1mg
Orodispersible tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Maharashtra State, India

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

Risperidone ODT Mylan
Risperidone 2mg
Orodispersible tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Maharashtra State, India

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

Risperidone ODT Mylan
Risperidone 3mg
Orodispersible tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Maharashtra State, India

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

Risperidone ODT Mylan
Risperidone 4mg
Orodispersible tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Maharashtra State, India

Dated this 6th day of November 2014.

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