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:*	Columvi (2.5mg/2.5mL)
Active Ingredient:	Glofitamab 1mg/mL
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	Roche Products (NZ) Limited
Manufacturer:	Genentech, Inc., California, United States of America

*Product:*	Columvi (10mg/10mL)
Active Ingredient:	Glofitamab 1mg/mL
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	Roche Products (NZ) Limited
Manufacturer:	Genentech, Inc., California, United States of America

*Product:*	Dapagliflozin Devatis
Active Ingredient:	Dapagliflozin 5mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Devatis Limited
Manufacturer:	Deva Holding AS, Tekirdag, Turkey

*Product:*	Dapagliflozin Devatis
Active Ingredient:	Dapagliflozin 10mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Devatis Limited
Manufacturer:	Deva Holding AS, Tekirdag, Turkey

*Product:*	Jubbonti
Active Ingredient:	Denosumab 60mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Sandoz New Zealand Limited
Manufacturer:	Novartis Pharmaceutical Manufacturing GmbH, Langkampfen, Austria

*Product:*	Midodrine
Active Ingredient:	Midodrine hydrochloride 2.5mg
Dosage Form:	Tablet
New Zealand Sponsor:	Max Health Limited
Manufacturer:	Emcure Pharmaceuticals Limited, Pune, India

*Product:*	Midodrine
Active Ingredient:	Midodrine hydrochloride 5mg
Dosage Form:	Tablet
New Zealand Sponsor:	Max Health Limited
Manufacturer:	Emcure Pharmaceuticals Limited, Pune, India

*Product:*	Wyost
Active Ingredient:	Denosumab 70mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Sandoz New Zealand Limited
Manufacturer:	Lek Pharmaceuticals d.d., Ljubljana, Slovenia

Dated this 26th day of May 2025.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11th September 2013).

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