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Welcome

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Apologies

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Declaration of conflicts of interest

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Applications for consent to distribute a new medicine under section 20 / 23 / 24 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

This product is a prescription medicine proposed for the treatment of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. The proposed indication for Lagevrio is the treatment of mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalisation.

Lagevrio has been developed by MSD in response to the global pandemic of SARS-CoV-2 virus that causes COVID-19.  The medicinal product consists of hard capsules containing the novel antiviral active ingredient molnupiravir, which is a synthetic nucleoside prodrug and prevents viral replication.  The capsules contain well established excipients and are packaged in bottles intended for supply and use in the community

The application is being referred to the Committee for independent advice as to whether the Minister of Health should grant provisional consent for the proposed indications. The Committee is also asked to consider the appropriateness of the conditions and duration proposed for consent.

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General business

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Date of next meeting