Evusheld

RSS
Withdrawn

This medicine's authorisation has been withdrawn

tixagevimab / cilgavimab
Medicine Human Withdrawn
  • Rolling review
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 12 September 2025, the European Commission withdrew the marketing authorisation for Evusheld (tixagevimab / cilgavimab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, AstraZeneca AB, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Evusheld was granted marketing authorisation in the EU on 25 March 2022 for pre-exposure prophylaxis and treatment of COVID-19. The marketing authorisation was initially valid for a 5-year period.

Evusheld : EPAR - Medicine overview

Reference Number: EMA/173193/2022

English (EN) (127.24 KB - PDF)

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български (BG) (157.43 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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español (ES) (127.7 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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čeština (CS) (152.61 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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dansk (DA) (127.8 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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Deutsch (DE) (131.19 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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eesti keel (ET) (113.82 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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ελληνικά (EL) (160.11 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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français (FR) (128.4 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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hrvatski (HR) (152.68 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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italiano (IT) (126.63 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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latviešu valoda (LV) (160.37 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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lietuvių kalba (LT) (150.13 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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magyar (HU) (152 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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Malti (MT) (152.23 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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Nederlands (NL) (129.03 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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polski (PL) (154.55 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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português (PT) (128.4 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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română (RO) (148.63 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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slovenčina (SK) (151.99 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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slovenščina (SL) (148.55 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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Suomi (FI) (124.99 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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svenska (SV) (125.52 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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Evusheld : EPAR - Risk-management-plan

English (EN) (881.12 KB - PDF)

First published: Last updated:
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Product information

Evusheld : EPAR - Product information

English (EN) (436.19 KB - PDF)

First published: Last updated:
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български (BG) (536.36 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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español (ES) (423.81 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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čeština (CS) (483.88 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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dansk (DA) (408.41 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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Deutsch (DE) (434.75 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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eesti keel (ET) (390.56 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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ελληνικά (EL) (529.17 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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français (FR) (448.85 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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hrvatski (HR) (444.38 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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íslenska (IS) (440.97 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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italiano (IT) (434.2 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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latviešu valoda (LV) (491.1 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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lietuvių kalba (LT) (450.53 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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magyar (HU) (600.86 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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Malti (MT) (489.18 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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Nederlands (NL) (471.36 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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norsk (NO) (424.16 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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polski (PL) (546.58 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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português (PT) (421.31 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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română (RO) (465.6 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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slovenčina (SK) (510.04 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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slovenščina (SL) (493.71 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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Suomi (FI) (411.23 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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svenska (SV) (428.17 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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Latest procedure affecting product information:IB/0019
11/10/2024
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Evusheld : EPAR - All authorised presentations

English (EN) (46.41 KB - PDF)

First published: Last updated:
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български (BG) (51.09 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

español (ES) (46.45 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

čeština (CS) (47.01 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

dansk (DA) (47.94 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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Deutsch (DE) (48.27 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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eesti keel (ET) (45.61 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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ελληνικά (EL) (50.32 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

français (FR) (46.19 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

hrvatski (HR) (46.7 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

íslenska (IS) (69.83 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

italiano (IT) (45.94 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

latviešu valoda (LV) (47.52 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

lietuvių kalba (LT) (56.83 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

magyar (HU) (47.55 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

Malti (MT) (47.28 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

Nederlands (NL) (46.85 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

norsk (NO) (47.57 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

polski (PL) (48.33 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

português (PT) (47.51 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

română (RO) (46.56 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

slovenčina (SK) (47.73 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

slovenščina (SL) (46.4 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
View

Suomi (FI) (66.19 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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svenska (SV) (46.14 KB - PDF)

First published: 30/03/2022 Last updated: 14/10/2025
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Product details

Name of medicine
Evusheld
Active substance
  • tixagevimab
  • cilgavimab
International non-proprietary name (INN) or common name
  • tixagevimab
  • cilgavimab
Therapeutic area (MeSH)
COVID-19 virus infection

Therapeutic indication

Prevention of COVID-19.

Authorisation details

EMA product number
EMEA/H/C/005788
Marketing authorisation holder
AstraZeneca AB

151 85 Sodertalje
Sweden

Opinion adopted
24/03/2022
Marketing authorisation issued
25/03/2022
Withdrawal of marketing authorisation
12/09/2025
Revision
10

Assessment history

Evusheld : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (159.67 KB - PDF)

First published: Last updated:
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Evusheld-H-C-5788-P46-024 : EPAR - Assessment report - Variation

Adopted Reference Number: EMA/56406/2025

English (EN) (1.44 MB - PDF)

First published: Last updated:
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Evusheld-H-C-PSUSA-00010992-202211 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Reference Number: EMA/374564/2023

English (EN) (135.93 KB - PDF)

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Evusheld : EPAR - Assessment report - variation

Adopted Reference Number: EMA/834036/2022

English (EN) (10.08 MB - PDF)

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CHMP post-authorisation summary of positive opinion for Evusheld (II-01)

Adopted Reference Number: EMA/759875/2022

English (EN) (156.63 KB - PDF)

First published: Last updated:
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Evusheld : EPAR - Public assessment report

Adopted Reference Number: EMA/205600/2022

English (EN) (9.41 MB - PDF)

First published: Last updated:
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CHMP summary of opinion for Evusheld

Adopted Reference Number: EMA/184295/2022

English (EN) (140.41 KB - PDF)

First published: Last updated:
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