Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Prochymal
Active Ingredient: Remestemcel-L 100 million human mesenchymal stem cells in 15mL
Dosage Form: Solution for infusion
New Zealand Sponsor: CARSL Consulting
Manufacturer: Lonza Walkersville, Inc, Maryland, United States of America
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 7th day of June 2012.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).