Decision

Regulatory approval of Evusheld (tixagevimab/cilgavimab)

Information for healthcare professionals and the public about Evusheld

• From: Medicines and Healthcare products Regulatory Agency
• Published: 17 March 2022
• Last updated: 15 November 2022
  Show all updates

  1. 15 November 2022

     The Summary of Product Characteristics and Patient Information Leaflet were updated to reflect the approval of Evusheld for the treatment of COVID-19 in adults who are at risk of progressing to severe disease. A new section on breakthrough infection or treatment failure due to antiviral resistance was added to the SmPC

  2. 17 March 2022

     First published.

Documents

Summary of Product Characteristics for Evusheld

HTML

Summary of Product Characteristics for Evusheld

PDF, 506 KB, 21 pages

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Patient Information Leaflet for Evusheld

HTML

Patient Information Leaflet for Evusheld

PDF, 184 KB, 6 pages

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Public Assessment Report for Evusheld

PDF, 5.44 MB, 87 pages

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Details

Information about EVUSHELD 150 mg / 150 mg solution for injection, approved by the MHRA on 17 March 2022.

The Summary of Product Characteristics 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.

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.

The Conditional Marketing Authorisation (CMA) granted by the MHRA is valid in Great Britain (GB).

See further information in our press release.

Ingredients

A full list of ingredients for the qualitative and quantitative composition of the medicine can be found at point 2 in the Summary of Product Characteristics for EVUSHELD 150mg/150mg solution for injection.

A full list of ingredients for the excipient composition of the medicine can be found at point 6.1 in the Summary of Product Characteristics for EVUSHELD 150mg/150mg solution for injection.

A full list of ingredients for the qualitative and quantitative composition of the medicine and a full list of the excipient composition of the medicine can be found at point 6 in the Patient Information Leaflet for EVUSHELD 150mg/150mg solution for injection.