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:
Manufacturers:

Afinitor
Everolimus 2.5mg
Tablet
Novartis New Zealand Limited
Novartis Pharma AG, Basel, Switzerland
Novartis Pharma Stein AG, Stein, Switzerland

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

Afinitor
Everolimus 5mg
Tablet
Novartis New Zealand Limited
Novartis Pharma AG, Basel, Switzerland
Novartis Pharma Stein AG, Stein, Switzerland

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

Afinitor
Everolimus 10mg
Tablet
Novartis New Zealand Limited
Novartis Pharma AG, Basel, Switzerland
Novartis Pharma Stein AG, Stein, Switzerland

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

Avaxim
Hepatitis A virus formaldehyde inactivated, GBM strain 160U
Suspension for injection
sanofi-aventis new zealand limited
Sanofi Pasteur SA, Marcy L’Etoile, France
Sanofi Pasteur SA, Val-De-Reuil, France

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

Certican
Everolimus 0.25mg
Tablet
Novartis New Zealand Limited
Novartis Pharma AG, Basel, Switzerland
Novartis Pharma Stein AG, Stein, Switzerland

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

Certican
Everolimus 0.5mg
Tablet
Novartis New Zealand Limited
Novartis Pharma AG, Basel, Switzerland
Novartis Pharma Stein AG, Stein, Switzerland

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

Certican
Everolimus 0.75mg
Tablet
Novartis New Zealand Limited
Novartis Pharma AG, Basel, Switzerland
Novartis Pharma Stein AG, Stein, Switzerland

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

Certican
Everolimus 1mg
Tablet
Novartis New Zealand Limited
Novartis Pharma AG, Basel, Switzerland
Novartis Pharma Stein AG, Stein, Switzerland

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

Certican
Everolimus 0.1mg
Dispersible tablet
Novartis New Zealand Limited
Novartis Pharma AG, Basel, Switzerland
Novartis Pharma Stein AG, Stein, Switzerland

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

Certican
Everolimus 0.25mg
Dispersible tablet
Novartis New Zealand Limited
Novartis Pharma AG, Basel, Switzerland
Novartis Pharma Stein AG, Stein, Switzerland

Dated this 11th day of September 2015.

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