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:
| Product: | Breztri Aerosphere |
| Active Ingredients: | Budesonide 160mcg Formoterol fumarate dihydrate 5mcg Glycopyrronium bromide 9mcg equivalent to glycopyrronium 7.2mcg |
| Dosage Form: | Aerosol inhaler, metered dose |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturers: | AstraZeneca Dunkerque Production SCS, Dunkerque, France Bespak HC Limited, Cheshire, United Kingdom |
| 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: | 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: | Skyrizi (Pre-filled pen) |
| Active Ingredient: | Risankizumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturer: | AbbVie Biotechnology Limited, Barceloneta, Puerto Rico |
| Product: | Skyrizi (Pre-filled syringe) |
| Active Ingredient: | Risankizumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturer: | AbbVie Biotechnology Limited, Barceloneta, Puerto Rico |
| Product: | Tezspire (Pre-filled pen) |
| Active Ingredient: | Tezepelumab 110mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturer: | Amgen Manufacturing Limited LLC, Juncos, Puerto Rico |
| Product: | Tezspire (Pre-filled syringe) |
| Active Ingredient: | Tezepelumab 110mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturer: | Amgen Manufacturing Limited LLC, Juncos, Puerto Rico |
| Product: | Winglore (50mg/10mL) |
| Active Ingredient: | Ipilimumab 5mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturers: | Simtra US LLC, Indiana, United States of America Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico Samsung Biologics Co Limited, Incheon, South Korea |
| Product: | Winglore (200mg/40mL) |
| Active Ingredient: | Ipilimumab 5mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturers: | Simtra US LLC, Indiana, United States of America Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico Samsung Biologics Co Limited, Incheon, South Korea |
| Product: | Yervoy (50mg/10mL) |
| Active Ingredient: | Ipilimumab 5mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturers: | Simtra US LLC, Indiana, United States of America Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico Samsung Biologics Co Limited, Incheon, South Korea |
| Product: | Yervoy (200mg/40mL) |
| Active Ingredient: | Ipilimumab 5mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturers: | Simtra US LLC, Indiana, United States of America Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico Samsung Biologics Co Limited, Incheon, South Korea |
Dated this 16th day of March 2026.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).