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:*	APO-Paracetamol 665mg
Active Ingredient:	Paracetamol 665mg
Dosage Form:	Modified release tablet
New Zealand Sponsor:	Arrotex Pharmaceuticals (NZ) Limited
Manufacturers:	Sri Krishna Pharmaceuticals Limited, Hyderabad, India Gracure Pharmaceuticals Limited, Bhiwadi, India

*Product:*	Fasenra
Active Ingredient:	Benralizumab 30mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	AstraZeneca Limited
Manufacturers:	AstraZeneca Pharmaceuticals LP, Maryland, United States of America Catalent Indiana LLC, Indiana, United States of America

*Product:*	Fasenra Pen
Active Ingredient:	Benralizumab 30mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	AstraZeneca Limited
Manufacturers:	AstraZeneca Pharmaceuticals LP, Maryland, United States of America AstraZeneca AB, Sodertalje, Sweden Catalent Indiana LLC, Indiana, United States of America

*Product:*	IPCA-Enalapril
Active Ingredient:	Enalapril maleate 5mg
Dosage Form:	Tablet
New Zealand Sponsor:	Ipca Pharma (NZ) Pty Limited
Manufacturer:	Ipca Laboratories Limited, Silvassa, India

*Product:*	IPCA-Enalapril
Active Ingredient:	Enalapril maleate 10mg
Dosage Form:	Tablet
New Zealand Sponsor:	Ipca Pharma (NZ) Pty Limited
Manufacturer:	Ipca Laboratories Limited, Silvassa, India

*Product:*	IPCA-Enalapril
Active Ingredient:	Enalapril maleate 20mg
Dosage Form:	Tablet
New Zealand Sponsor:	Ipca Pharma (NZ) Pty Limited
Manufacturer:	Ipca Laboratories Limited, Silvassa, India

*Product:*	Osteo Relief Paracetamol
Active Ingredient:	Paracetamol 665mg
Dosage Form:	Modified release tablet
New Zealand Sponsor:	Arrotex Pharmaceuticals (NZ) Limited
Manufacturers:	Sri Krishna Pharmaceuticals Limited, Hyderabad, India Gracure Pharmaceuticals Limited, Bhiwadi, India

*Product:*	Paracetamol 665mg
Active Ingredient:	Paracetamol 665mg
Dosage Form:	Modified release tablet
New Zealand Sponsor:	Arrotex Pharmaceuticals (NZ) Limited
Manufacturers:	Sri Krishna Pharmaceuticals Limited, Hyderabad, India Gracure Pharmaceuticals Limited, Bhiwadi, India

Dated this 3rd day of September 2024.

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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