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:*	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

*Product:*	Rinvoq
Active Ingredient:	Upadacitinib hemihydrate 15.4mg equivalent to upadacitinib 15mg
Dosage Form:	Modified release tablet
New Zealand Sponsor:	AbbVie Limited
Manufacturer:	AbbVie Ireland NL B.V., Sligo, Ireland

*Product:*	Rinvoq
Active Ingredient:	Upadacitinib hemihydrate 30.7mg equivalent to upadacitinib 30mg
Dosage Form:	Modified release tablet
New Zealand Sponsor:	AbbVie Limited
Manufacturer:	AbbVie Ireland NL B.V., Sligo, Ireland

*Product:*	Rinvoq
Active Ingredient:	Upadacitinib hemihydrate 46.1mg equivalent to upadacitinib 45mg
Dosage Form:	Modified release tablet
New Zealand Sponsor:	AbbVie Limited
Manufacturer:	AbbVie Ireland NL B.V., Sligo, Ireland

*Product:*	Tafinlar
Active Ingredient:	Dabrafenib mesilate 59.25mg equivalent to dabrafenib 50mg
Dosage Form:	Capsule
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturers:	Glaxo Operations UK Limited t/a Glaxo Wellcome Operations,Ware, United Kingdom Siegfried Barbera SL, Barcelona, Spain Novartis Pharmaceutical Manufacturing LLC, Ljubljana, Slovenia

*Product:*	Tafinlar
Active Ingredient:	Dabrafenib mesilate 88.88mg equivalent to dabrafenib 75mg
Dosage Form:	Capsule
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturers:	Glaxo Operations UK Limited t/a Glaxo Wellcome Operations, Ware, United Kingdom Novartis Farmaceutica SA, Barcelona, Spain Siegfried Barbera SL, Barcelona, Spain Novartis Pharmaceutical Manufacturing LLC, Ljubljana, Slovenia

Dated this 29th day of May 2025.

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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