Consent to the Distribution of a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

*Product:*	Icatibant Lupin
Active Ingredient:	Icatibant acetate 10.5mg/mL equivalent to icatibant 10mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Lupin NZ Limited
Manufacturer:	Universal Farma, S.L., Guadalajara, Spain

Dated this 1st day of September 2025.

MATTHEW SPENCER, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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Schedule