Provisional Consent to the Distribution of a New Medicine
Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:
| Product: | Libtayo |
| Active Ingredient: | Cemiplimab 50mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Catalent Indiana LLC, Indiana, United States of America |
Note: This consent is given subject to the following condition:
The New Zealand Sponsor must provide confirmatory efficacy and safety data from ongoing and future clinical trials, in particular study 1540, as soon as they become available.
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 23rd day of June 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).