Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:

Schedule

Provisional consent is granted for two years from 14 April 2024.

This consent is given subject to the following conditions:

The New Zealand Sponsor must fulfil the following obligations within the timelines specified, which may be altered by mutual agreement with Medsafe:

1. Provide confirmatory clinical trial data as identified in the sponsor's plan to submit comprehensive safety and efficacy data within six years from consent being granted within five working days of any reports being produced.
2. Provide updates regarding the clinical activity, efficacy, and effectiveness against the current and future Variants of Concern and Variants of Interest identified by the World Health Organization (WHO) within five working days of any reports being produced.
3. Provide further data relating to safety and efficacy in immunocompromised subjects, pregnant women, lactating mothers, paediatric subjects, patients with hepatic impairment as well as additional pharmacology and long-term safety data and information relating to post-market safety and efficacy studies within five working days of any reports being produced.
4. Provide the results from any non-sponsor led clinical studies involving Lagevrio within five working days of any reports being produced.

Dated this 10th day of April 2024.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).