Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out
in the Schedule hereto:
Schedule
Product: Rapilysin
Active Ingredient: Reteplase 10U
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Dated this 12th day of September 2013.
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).