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 — See all updates

Documents

Summary of Product Characteristics for Evusheld

HTML

Summary of Product Characteristics for Evusheld

PDF, 506 KB, 21 pages

This file may not be suitable for users of assistive technology.

Request an accessible format.

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Patient Information Leaflet for Evusheld

HTML

Patient Information Leaflet for Evusheld

PDF, 184 KB, 6 pages

This file may not be suitable for users of assistive technology.

Request an accessible format.

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Public Assessment Report for Evusheld

PDF, 5.44 MB, 87 pages

This file may not be suitable for users of assistive technology.

Request an accessible format.

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

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.

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.