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:*	Benzatropine Injection
Active Ingredient:	Benzatropine mesilate 1mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Phebra NZ Limited
Manufacturer:	Phebra Pty Limited, Sydney, Australia

*Product:*	Colgout
Active Ingredient:	Colchicine 0.5mg
Dosage Form:	Tablet
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers:	Aspen Pharma Pty Limited, Melbourne, Australia Strides Pharma Science Limited, Bangalore, India

*Product:*	Dizole 50
Active Ingredient:	Fluconazole 50mg
Dosage Form:	Capsule
New Zealand Sponsor:	Arrotex Pharmaceuticals (NZ) Limited
Manufacturer:	Mylan Laboratories Limited, Nashik, India

*Product:*	Flucazole
Active Ingredient:	Fluconazole 150mg
Dosage Form:	Capsule
New Zealand Sponsor:	Arrotex Pharmaceuticals (NZ) Limited
Manufacturer:	Mylan Laboratories Limited, Nashik, India

*Product:*	Fluconazole
Active Ingredient:	Fluconazole 50mg
Dosage Form:	Capsule
New Zealand Sponsor:	Arrotex Pharmaceuticals (NZ) Limited
Manufacturer:	Mylan Laboratories Limited, Nashik, India

*Product:*	Fluconazole
Active Ingredient:	Fluconazole 150mg
Dosage Form:	Capsule
New Zealand Sponsor:	Arrotex Pharmaceuticals (NZ) Limited
Manufacturer:	Mylan Laboratories Limited, Nashik, India

*Product:*	Fluconazole
Active Ingredient:	Fluconazole 200mg
Dosage Form:	Capsule
New Zealand Sponsor:	Arrotex Pharmaceuticals (NZ) Limited
Manufacturer:	Mylan Laboratories Limited, Nashik, India

*Product:*	Opdivo (40mg/4mL)
Active Ingredient:	Nivolumab 10mg/mL
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	Bristol-Myers Squibb (NZ) Limited
Manufacturers:	Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico

*Product:*	Opdivo (100mg/10mL)
Active Ingredient:	Nivolumab 10mg/mL
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	Bristol-Myers Squibb (NZ) Limited
Manufacturers:	Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico

Dated this 12th 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).

Tags

Notice Number

Schedule