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:*	Brenzys (Pre-filled Syringe)
Active Ingredient:	Etanercept 50mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Samsung Bioepis NZ Limited
Manufacturers:	Patheon Italia S.p.A, Milan, Italy Catalent Belgium SA, Brussels, Belgium

*Product:*	Brenzys (Pre-filled Pen)
Active Ingredient:	Etanercept 50mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Samsung Bioepis NZ Limited
Manufacturers:	Patheon Italia S.p.A, Milan, Italy Catalent Belgium SA, Brussels, Belgium

*Product:*	Macrobid
Active Ingredients:	Nitrofurantoin 25mg Nitrofurantoin monohydrate 80.7mg
Dosage Form:	Modified release capsule
New Zealand Sponsor:	Te Arai BioFarma Limited
Manufacturer:	Norwich Pharmaceuticals Inc, New York, United States of America

Dated this 11th day of November 2025.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 1 September 2013).

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