Notice Type
Notice Title

Renewal of Provisional Consent to the Distribution of Medicines

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 medicines set out in the Schedule hereto:
Product: Prochymal
Active Ingredient: Remestemcel-L 100 million cells in 15mL
Dosage Form: Solution for infusion
New Zealand Sponsor: CARSL Consulting
Manufacturer: Lonza Walkersville, Maryland, United States of America
Note: This renewed consent is valid for two years from 14 June 2014.
Product: Pandemic Influenza Vaccine H5N1 Baxter
Active Ingredient: Influenza vaccine whole virion, vero cell derived, inactivated 7.5mcg
Dosage Form: Suspension for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter AG, Lange Allee 51, Vienna, Austria
Baxter AG, Lange Allee 24, 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 5 August 2014.
Dated this 30th day of May 2014.
SUSAN MARTINDALE, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).