Decision

Regulatory approval of Lagevrio (molnupiravir)

Information for healthcare professionals and the public about Lagevrio

Documents

Last updated 19/10/22 - Summary of Product Characteristics for Lagevrio

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Patient Information Leaflet for Lagevrio

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Conditions of Authorisation for Lagevrio (Regulation 174)

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Public Assessment Report for Lagevrio

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Details

The MHRA has issued a Conditional Marketing Authorisation for Lagevrio (molnupiravir) in Great Britain and a temporary Regulation 174 authorisation for Northern Ireland to ensure supply across all of the UK. If the European Medicines Agency grants a CMA for Lagevrio it would apply in Northern Ireland and the Regulation 174 authorisation would no longer be in place.

Supply of this product will be subject to the same requirements in Great Britain and Northern Ireland, and the product information on this page applies to both authorisations.

The information for healthcare professionals and UK recipients on using Lagevrio safely will be periodically updated as new data become available and this will continue when the CMA is converted to a MA. Please regularly check this information as it is often updated.

Lagevrio authorised under Regulation 174 is kept in line with the product information of the GB CMA.

Summary of Product Characteristics

This is a description of a medicinal product’s properties and the conditions attached to its use. It explains how to use and prescribe a medicine. It is used by healthcare professionals, such as doctors, nurses and pharmacists.

Patient Information Leaflet

The Patient Information Leaflet provides information for patients on using the medicine safely. This is based on the Summary of Product Characteristics of the product.

Public Assessment Report

The Public Assessment Report is a scientific report, written by the MHRA. It explains how this product was assessed and its authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use this product.

Updates to this page

Published 4 November 2021
Last updated 28 November 2022 + show all updates
  1. The SmPC (HTML) and SmPC (PDF) attachments have been updated as the shelf life of Lagevrio has been extended from 18 to 30 months from initial manufacture.

  2. Public Assessment Report for Lagevrio published.

  3. First published.

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