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:*	Arexvy
Active Ingredient:	Recombinant respiratory syncytial virus pre-fusion F protein 120mcg
Component 1:
Dosage Form:	Powder for injection
Component 2:
Dosage Form:	Suspension for injection
New Zealand Sponsor:	GlaxoSmithKline NZ Limited
Manufacturers:	GlaxoSmithKline Biologicals SA, Wavre, Belgium GlaxoSmithKline Vaccines SRL, Sovicille, Italy

*Product:*	Imfinzi
Active Ingredient:	Durvalumab 120mg
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	AstraZeneca Limited
Manufacturers:	Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany AstraZeneca AB, Gartunavagen, Sodertalje, Sweden Catalent Indiana LLC, Indiana, United States of America

*Product:*	Imfinzi
Active Ingredient:	Durvalumab 500mg
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	AstraZeneca Limited
Manufacturers:	Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany AstraZeneca AB, Gartunavagen, Sodertalje, Sweden Catalent Indiana LLC, Indiana, United States of America

*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 MSD International GmbH, t/a MSD Ireland (Carlow), Carlow, Ireland

*Product:*	Panadol Mini Caps (General sale)
Active Ingredient:	Paracetamol 500mg
Dosage Form:	Coated tablet
New Zealand Sponsor:	Haleon New Zealand ULC
Manufacturers:	Sterling Drug (Malaya) Sdn Bhd, Ampang, Malaysia Granules India Limited, Hyderabad, India

*Product:*	Panadol Mini Caps (Pharmacy only)
Active Ingredient:	Paracetamol 500mg
Dosage Form:	Coated tablet
New Zealand Sponsor:	Haleon New Zealand ULC
Manufacturers:	Sterling Drug (Malaya) Sdn Bhd, Ampang, Malaysia Granules India Limited, Hyderabad, India

Dated this 2nd 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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