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: | Tecfidera |
| Active Ingredient: | Dimethyl fumarate 120mg |
| Dosage Form: | Modified release capsule |
| New Zealand Sponsor: | Biogen NZ Biopharma Limited |
| Manufacturers: | Janssen-Cilag SpA, Latina, Italy Corden Pharma Fribourg SA, Villars-sur-Glane, Switzerland |
| Product: | Tecfidera |
| Active Ingredient: | Dimethyl fumarate 240mg |
| Dosage Form: | Modified release capsule |
| New Zealand Sponsor: | Biogen NZ Biopharma Limited |
| Manufacturers: | Janssen-Cilag SpA, Latina, Italy Corden Pharma Fribourg SA, Villars-sur-Glane, Switzerland |
Dated this 4th day of December 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).