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:*	Advil Children 7-12 Years Pain & Fever Relief (Pharmacy only)
Active Ingredient:	Ibuprofen 100mg
Dosage Form:	Chewable tablet
New Zealand Sponsor:	Haleon New Zealand ULC
Manufacturers:	PF Consumer Healthcare Canada ULC, Montreal, Canada

*Product:*	Advil Children 7-12 Years Pain & Fever Relief (General sale)
Active Ingredient:	Ibuprofen 100mg
Dosage Form:	Chewable tablet
New Zealand Sponsor:	Haleon New Zealand ULC
Manufacturer:	PF Consumer Healthcare Canada ULC, Montreal, Canada

*Product:*	Fludrocortisone (Medicianz)
Active Ingredient:	Fludrocortisone acetate 0.1mg
Dosage Form:	Tablet
New Zealand Sponsor:	Medsurge Pharma Limited
Manufacturer:	Adamed Pharma SA, Pabianice, Poland

*Product:*	Fludrocortisone (Medsurge)
Active Ingredient:	Fludrocortisone acetate 0.1mg
Dosage Form:	Tablet
New Zealand Sponsor:	Medsurge Pharma Limited
Manufacturer:	Adamed Pharma SA, Pabianice, Poland

*Product:*	Keytruda
Active Ingredient:	Pembrolizumab 25mg/mL
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	Merck Sharp & Dohme (New Zealand) Limited
Manufacturers:	MSD International GmbH (Singapore Branch), Singapore City, Singapore MSD International GmbH, t/a MSD Ireland (Carlow), Carlow, Ireland

*Product:*	KISQALI
Active Ingredient:	Ribociclib succinate 254.4mg equivalent to ribociclib 200mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturers:	Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Singapore City, Singapore Novartis Pharmaceutical Manufacturing LLC, Ljubljana, Slovenia

*Product:*	Tagrisso
Active Ingredient:	Osimertinib mesilate 47.7mg equivalent to osimertinib 40mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	AstraZeneca Limited
Manufacturer:	AstraZeneca AB, Sodertalje, Sweden

*Product:*	Tagrisso
Active Ingredient:	Osimertinib mesilate 95.4mg equivalent to osimertinib 80mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	AstraZeneca Limited
Manufacturer:	AstraZeneca AB, Sodertalje, Sweden

*Product:*	Utrogestan
Active Ingredient:	Progesterone 200mg
Dosage Form:	Capsule
New Zealand Sponsor:	Pharmaco (NZ) Limited
Manufacturers:	Olic (Thailand) Limited, Ayutthaya, Thailand Cyndea Pharma S.L., Soria, Spain NextPharma Ploermel, Ploermel, France

Dated this 27th day of June 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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