Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

Publication Date
16 Mar 2023

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2023-go996
Title
View PDF
File Type and Size
PDF (34 KB)

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: Takeda New Zealand Limited
Manufacturer: Takeda Manufacturing Austria AG, Vienna, Austria
   
Product: FEIBA NF
Active Ingredient: Factor VIII inhibitor bypassing fraction 1000U
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Takeda New Zealand Limited
Manufacturer: Takeda Manufacturing Austria AG, Vienna, Austria
   
Product: FEIBA NF
Active Ingredient: Factor VIII inhibitor bypassing fraction 2500U
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Takeda New Zealand Limited
Manufacturer: Takeda Manufacturing Austria AG, Vienna, Austria


Dated this 13th day of March 2023.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).