Gazette.govt.nzPursuant 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).