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)
Syringe 1:
Active Ingredients: Aprotinin 2250kIU - 3750kIU
Factor XIII 1.2IU/mL - 10IU/mL
Fibrinogen 72mg/mL - 110mg/mL
Dosage Form: Sealer Protein Topical solution
Syringe 2:
Active Ingredients: Calcium chloride dihydrate 0.036mmol/mL - 0.044mmol/mL
Thrombin 400IU/mL - 625IU/mL
Dosage Form: Thrombin Topical solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter AG, Lange Allee 24, Vienna, Austria
Baxter AG, Industriestrasse 72, Vienna, Austria
Dated this 21st day of February 2013.
DR STEWART JESSAMINE, Acting 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).