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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:

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:
Manufacturer:

Gadovist 1.0
Gadobutrol 604.72mg equivalent to 1mmol/mL
Solution for injection
Bayer New Zealand Limited
Bayer Pharma AG, Berlin, Germany

Dated this 29th day of January 2016.

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

Publication Date
4 Feb 2016

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2016-go539

Issue Number

10
Title
View PDF
Description
Principal Edition, 4 February 2016
File Type and Size
PDF (21 KB)
Page Number 0