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 are set out in the Schedule hereto:

Schedule

*Product:*	Estradiol
Active Ingredient:	Estradiol hemihydrate 0.42mg equivalent to estradiol 0.41mg
Dosage Form:	Transdermal patch
New Zealand Sponsor:	Viatris Limited
Manufacturer:	Mylan Technologies, Vermont, United States of America

*Product:*	Estradiol
Active Ingredient:	Estradiol hemihydrate 0.85mg equivalent to estradiol 0.82mg
Dosage Form:	Transdermal patch
New Zealand Sponsor:	Viatris Limited
Manufacturer:	Mylan Technologies, Vermont, United States of America

*Product:*	Estradiol
Active Ingredient:	Estradiol hemihydrate 1.27mg equivalent to estradiol 1.23mg
Dosage Form:	Transdermal patch
New Zealand Sponsor:	Viatris Limited
Manufacturer:	Mylan Technologies, Vermont, United States of America

*Product:*	Estradiol
Active Ingredient:	Estradiol hemihydrate 1.7mg equivalent to estradiol 1.64mg
Dosage Form:	Transdermal patch
New Zealand Sponsor:	Viatris Limited
Manufacturer:	Mylan Technologies, Vermont, United States of America

*Product:*	Kalydeco
Active Ingredient:	Ivacaftor 13.4mg
Dosage Form:	Oral granules
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers:	Almac Pharma Services Limited, Craigavon, United Kingdom Halo Pharmaceutical Inc, New Jersey, United States of America Catalent Greenville Inc, North Carolina, United States of America

*Product:*	Xofluza
Active Ingredient:	Baloxavir marboxil 80mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Roche Products (NZ) Limited
Manufacturers:	Shionogi Pharma Co. Limited, Settsu, Japan F Hoffmann-La Roche AG, Kaiseraugst, Switzerland

Dated this 20th day of May 2025.

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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