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:
Manufacturer:

FluQuadri
Influenza virus A/California/7/2009 (H1N1) – like strain 15mcg
Influenza virus A/Victoria/361/2011 (H3N2) – like strain 15mcg
Influenza virus B/Brisbane/60/2008 – like strain 15mcg
Influenza virus B/Massachusetts/2/2012 – like strain 15mcg
Suspension for injection
sanofi-aventis new zealand limited
Sanofi Pasteur Inc, Pennsylvania, United States of America

Product:
Active Ingredients:



Dosage Form:

New Zealand Sponsor:
Manufacturer:

FluQuadri Junior
Influenza virus A/California/7/2009 (H1N1) – like strain 7.5mcg
Influenza virus A/Victoria/361/2011 (H3N2) – like strain 7.5mcg
Influenza virus B/Brisbane/60/2008 – like strain 7.5mcg
Influenza virus B/Massachusetts/2/2012 – like strain 7.5mcg
Suspension for injection
sanofi-aventis new zealand limited
Sanofi Pasteur Inc, Pennsylvania, United States of America

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

Levoclear
Levocetirizine hydrochloride 5mg
Film coated tablet
AFT Pharmaceuticals Limited
Zaklad Farmaceutyczny Adamed Pharma S.A., Ksawerow, Poland

Product:
Active Ingredient/s:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Xeomin
Botulinum toxin type A 50LD50 Units
Powder for injection
New Zealand Medical & Scientific Limited
Merz Pharma GmbH & Co KGaA, Dessau-Rosslau, Germany
IDT Biologika GmbH, Dessau-Rosslau, Germany

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

Xeomin
Botulinum toxin type A 100LD50 Units
Powder for injection
New Zealand Medical & Scientific Limited
Merz Pharma GmbH & Co KGaA, Dessau-Rosslau, Germany
IDT Biologika GmbH, Dessau-Rosslau, Germany

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

Zaltrap
Aflibercept 25mg/mL (100mg/4mL)
Concentrate for infusion
sanofi-aventis new zealand limited
Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany

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

Zaltrap
Aflibercept 25mg/mL (200mg/8mL)
Concentrate for infusion
sanofi-aventis new zealand limited
Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany

Dated this 12th day of December 2014.

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