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 set out in the Schedule hereto:

Schedule

*Product:*	Dizole 50
Active Ingredient:	Fluconazole 50mg
Dosage Form:	Capsule
New Zealand Sponsor:	Viatris Limited
Manufacturer:	Mylan Laboratories Limited, Nashik, India

*Product:*	Mersynofen (Pharmacy Only)
Active Ingredients:	Ibuprofen 200mg Paracetamol 500mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	sanofi-aventis new zealand limited
Manufacturer:	Sanofi Vietnam Shareholding Company, Ho Chi Minh City, Vietnam

*Product:*	Mersynofen (General Sale)
Active Ingredients:	Ibuprofen 200mg Paracetamol 500mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	sanofi-aventis new zealand limited
Manufacturer:	Sanofi Vietnam Shareholding Company, Ho Chi Minh City, Vietnam

*Product:*	Phesgo
Active Ingredients:	Pertuzumab 60mg/mL Trastuzumab 60mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Roche Products (NZ) Limited
Manufacturer:	F. Hoffmann-La Roche Limited, Kaiseraugst, Switzerland

*Product:*	Phesgo
Active Ingredients:	Pertuzumab 80mg/mL Trastuzumab 40mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Roche Products (NZ) Limited
Manufacturer:	F. Hoffmann-La Roche Limited, Kaiseraugst, Switzerland

*Product:*	Spy Agent Green
Active Ingredient:	Indocyanine green 25mg
Dosage Form:	Powder for injection
New Zealand Sponsor:	Stryker New Zealand Limited
Manufacturer:	Patheon Italia SpA, 2° Trav. SX V, Ferentino, Italy

*Product:*	Yuflyma (Pre-filled syringe)
Active Ingredient:	Adalimumab 100mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Celltrion Healthcare New Zealand Limited
Manufacturer:	Catalent Belgium SA, Brussels, Belgium

*Product:*	Yuflyma (Pre-filled syringe with needle guard)
Active Ingredient:	Adalimumab 100mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Celltrion Healthcare New Zealand Limited
Manufacturer:	Catalent Belgium SA, Brussels, Belgium

*Product:*	Yuflyma (Pre-filled pen)
Active Ingredient:	Adalimumab 100mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Celltrion Healthcare New Zealand Limited
Manufacturer:	Catalent Belgium SA, Brussels, Belgium

Dated this 16th day of September 2022.

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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