Regulatory approval of Xevudy (sotrovimab)
Information for healthcare professionals and the public about Xevudy (sotrovimab).
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Details
The MHRA has issued a Conditional Marketing Authorisation for Xevudy (sotrovimab) 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 Xevudy 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 Xevudy 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.
Xevudy authorised under Regulation 174 is kept in line with the product information of the GB CMA.
The Public Assessment Report will be published shortly.
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.
Last updated 28 March 2022 + show all updates
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Uploaded the Public Assessment Report for Xevudy
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First published.