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 set out in the Schedule hereto:
Schedule
Product: Evicel
Component 1
Active Ingredient: Fibrinogen 50mg/mL to 90mg/mL
Component 2
Active Ingredient: Thrombin 800IU/mL to 1200IU/mL
Dosage Form: Solution
New Zealand Sponsor: Johnson & Johnson Medical New Zealand Limited
Manufacturer: Omrix Biopharmaceuticals Limited, Kiryat-Ono, Israel
Dated this 10th day of April 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).