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: | No Doz |
| Active Ingredient: | Caffeine 100mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Wilson Foods Limited |
| Manufacturers: | Cipla Limited, District Raigad, India Mega Lifesciences (Australia) Pty Limited, Melbourne, Australia |
| 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: | 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 |
Product: |
Zerbaxa |
| Active Ingredients: | Ceftolozane sulfate 1147mg equivalent to ceftolozane 1000mg Tazobactam sodium 537mg equivalent to tazobactam 500mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturer: | Steri-Pharma LLC, New York, United States of America |
Dated this 9th day of February 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).