Consent to the Distribution of New Medicines

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:*	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).

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