Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: FEIBA NF
Active Ingredient: Factor VIII inhibitor bypassing fraction 500U
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter AG, Vienna, Austria
Product: FEIBA NF
Active Ingredient: Factor VIII inhibitor bypassing fraction 1000U
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter AG, Vienna, Austria
Product: FEIBA NF
Active Ingredient: Factor VIII inhibitor bypassing fraction 2500U
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter AG, Vienna, Austria
Dated this 16th day of January 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).