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:*	Afqlir (vial)
Active Ingredient:	Aflibercept 40mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Sandoz New Zealand Limited
Manufacturer:	PCI San Diego Inc., California, United States of America

*Product:*	Afqlir (pre-filled syringe)
Active Ingredient:	Aflibercept 40mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Sandoz New Zealand Limited
Manufacturer:	Novartis Manufacturing NV, Puurs-Sint-Amands, Belgium

*Product:*	Ganirelix-AFT
Active Ingredient:	Ganirelix acetate 0.5mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	AFT Pharmaceuticals Limited
Manufacturer:	Qilu Pharmaceutical Co Limited, Jinan, China

*Product:*	Ibuprofen SR
Active Ingredient:	Ibuprofen 800mg
Dosage Form:	Modified release tablet
New Zealand Sponsor:	Medreich New Zealand Limited
Manufacturer:	Medreich Limited, Bangalore, India

*Product:*	Medreich Ibuprofen SR
Active Ingredient:	Ibuprofen 800mg
Dosage Form:	Modified release tablet
New Zealand Sponsor:	Medreich New Zealand Limited
Manufacturer:	Medreich Limited, Bangalore, India

*Product:*	Steqeyma
Active Ingredient:	Ustekinumab 5mg/mL
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	Celltrion Healthcare New Zealand Limited
Manufacturer:	Gensenta llac Sanayii ve Ticaret A.S., Instanbul, Turkey

*Product:*	Steqeyma (90mg/1 mL)
Active Ingredient:	Ustekinumab 90mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Celltrion Healthcare New Zealand Limited
Manufacturer:	Celltrion Pharm Inc, Cheongju-si, South Korea

*Product:*	Steqeyma (45mg/0.5mL)
Active Ingredient:	Ustekinumab 90mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Celltrion Healthcare New Zealand Limited
Manufacturer:	Celltrion Pharm Inc, Cheongju-si, South Korea

*Product:*	Tadalafil Lupin
Active Ingredient:	Tadalafil 5mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Lupin NZ Limited
Manufacturer:	Lupin Limited, Nagpur, India

*Product:*	Tadalafil Lupin
Active Ingredient:	Tadalafil 10mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Lupin NZ Limited
Manufacturer:	Lupin Limited, Nagpur, India

*Product:*	Tadalafil Lupin
Active Ingredient:	Tadalafil 20mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Lupin NZ Limited
Manufacturer:	Lupin Limited, Nagpur, India

Dated this 3rd day of October 2025.

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

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