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: | Opdivo |
| Active Ingredient: | Nivolumab 47mg equivalent to 40mg/4mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturer: | Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico |
| Note: The application received 23 October 2018 is for extension of indications. | |
| Product: | Opdivo |
| Active Ingredient: | Nivolumab 107mg equivalent to 100mg/10mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturer: | Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico |
| Note: The application received 23 October 2018 is for extension of indications. | |
| Product: | Opdivo |
| Active Ingredient: | Nivolumab 47mg equivalent to 40mg/4mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturer: | Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico |
| Note: The application received 4 February 2019 is to register an additional dose regimen. | |
| Product: | Opdivo |
| Active Ingredient: | Nivolumab 107mg equivalent to 100mg/10mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturer: | Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico |
| Note: The application received 4 February 2019 is to register an additional dose regimen. | |
Dated this 26th day of August 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).