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 (frozen)
Active Ingredients: Aprotinin 2250kIU - 3750kIU
Factor XIII 1.2IU/mL
Fibrinogen 72mg/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
Manufacturers: Baxter AG, Lange Allee 24, Vienna, Austria
Baxter AG, Industriestrasse 72, Vienna, Austria
Dated this 25th day of August 2011.
DEBORAH KENT, Acting Deputy Director-General, Clinical Leadership, Protection and Regulation (pursuant to delegation given by the Minister of Health on 6 July 2001).