Notice Title

Renewal of Provisional Consent to the Distribution of a Medicine

Publication Date
28 May 2015

Tags

Medicines Act Renewal of provisional consent to the distribution of medicines Health

Notice Number

2015-go3070

Issue Number

58
Title
View PDF
File Type and Size
PDF (21 KB)

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:

Schedule

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

Vepacel
Influenza vaccine whole virion, vero cell derived, inactivated 7.5mcg/0.5mL
Suspension for injection
Baxter Healthcare Limited
Baxter AG, Vienna, Austria

Note: This consent is given subject to the following conditions:

The vaccine may only be marketed or distributed in accordance with the directives contained in the current version of the New Zealand Influenza Pandemic Action Plan.

Note: This renewed consent is valid for two years from 25 July 2015.

Dated this 22nd day of May 2015.

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