Published: 17 July 2022
Committees
SUMMARY OF RECOMMENDATIONS FROM THE 117TH MEETING OF THE MEDICINES ASSESSMENT ADVISORY COMMITTEE HELD IN WELLINGTON ON TUESDAY 12 April 2022
4. |
Applications for consent to distribute a new medicine under section 23 of the Medicines Act 1981 (referred by the Minister of Health under section 22(2)) |
4.1 |
Lagevrio (molnupiravir), Capsule, 200mg (Merck Sharp and Dohme (New Zealand) Limited |
The Committee recommended that the delegate of the Minister of Health should grant provisional consent to the distribution of this new medicine under section 23 of the Medicines Act 1981 with appropriate conditions. The Committee recommended changes to product information and agreed to Medsafe’s proposal that the provisional consent should be valid for two years. |