Gazette.govt.nzPursuant 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: | Keytruda |
| Active Ingredient: | Pembrolizumab 25mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturer: | MSD International GmbH, t/a MSD Ireland (Carlow), Carlow, Ireland |
| Note: The application received 8 September 2020. | |
| Product: | Keytruda |
| Active Ingredient: | Pembrolizumab 25mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturer: | MSD International GmbH, t/a MSD Ireland (Carlow), Carlow, Ireland |
| Note: The application received 7 June 2021. | |
| Product: | Lenvima |
| Active Ingredient: | Lenvatinib mesilate 4.9mg equivalent to lenvatinib 4mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturers: | Eisai Co Limited, Kakamigahara-shi, Japan Patheon Inc, Mississauga, Canada |
| Product: | Lenvima |
| Active Ingredient: | Lenvatinib mesilate 12.25mg equivalent to lenvatinib 10mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturers: | Eisai Co Limited, Kakamigahara-shi, Japan Patheon Inc, Mississauga, Canada |
| Product: | Opdivo (40mg/4mL) |
| Active Ingredient: | Nivolumab 10mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturers: | Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
| Note: The application received 31 May 2021 with the application ID 112686. | |
| Product: | Opdivo (40mg/4mL) |
| Active Ingredient: | Nivolumab 10mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturers: | Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
| Note: The application received 31 May 2021 with the application ID 112688. | |
| Product: | Opdivo (100mg/10mL) |
| Active Ingredient: | Nivolumab 10mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturers: | Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
| Note: The application received 31 May 2021 with the application ID 112686. | |
| Product: | Opdivo (100mg/10mL) |
| Active Ingredient: | Nivolumab 10mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturers: | Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
| Note: The application received 31 May 2021 with the application ID 112688. | |
| Product: | Winglore (50mg/10mL) |
| Active Ingredient: | Ipilimumab 5mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturers: | Baxter Pharmaceutical Solutions LLC, Indiana, United States of America Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico |
| Product: | Winglore (200mg/40mL) |
| Active Ingredient: | Ipilimumab 5mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturers: | Baxter Pharmaceutical Solutions LLC, Indiana, United States of America Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico |
| Product: | Yervoy (50mg/10mL) |
| Active Ingredient: | Ipilimumab 5mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturers: | Baxter Pharmaceutical Solutions LLC, Indiana, United States of America Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico |
| Product: | Yervoy (200mg/40mL) |
| Active Ingredient: | Ipilimumab 5mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturers: | Baxter Pharmaceutical Solutions LLC, Indiana, United States of America Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico |
Dated this 20th day of January 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).