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: Tisseel Fibrin Sealant VH S/D
Active Ingredients: Aprotinin 2250kIU – 3750kIU
Factor XIII 1.2IU/mL – 10IU/mL
Fibrinogen 72mg/mL – 110mg/mL
Dosage Form: Syringe 1 Topical solution
Active Ingredients: Calcium chloride dihydrate 0.4mmol/L
Thrombin 500IU/mL
Dosage Form: Syringe 2 Topical solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter AG, Vienna, Austria
Dated this 22nd day of October 2009.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).