VidPrevtyn Beta
Withdrawn
This medicine's authorisation has been withdrawn
COVID-19 Vaccine (recombinant, adjuvanted)
MedicineHumanWithdrawn
- Rolling review
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Vidprevtyn Beta has been withdrawn at the request of the marketing-authorisation holder.
VidPrevtyn Beta : EPAR - Medicine overview
Reference Number: EMA/872778/2022
English (EN) (236.94 KB - PDF)
First published: Last updated:
български (BG) (332.14 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
español (ES) (247.63 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
čeština (CS) (301.37 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
dansk (DA) (241.25 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
Deutsch (DE) (260.4 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
eesti keel (ET) (220.24 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
ελληνικά (EL) (340.19 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
français (FR) (253.61 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
hrvatski (HR) (287.1 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
italiano (IT) (243.5 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
latviešu valoda (LV) (300.67 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
lietuvių kalba (LT) (296.7 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
magyar (HU) (278.93 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
Malti (MT) (317.29 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
Nederlands (NL) (258.51 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
polski (PL) (314.64 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
português (PT) (248.32 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
română (RO) (308.86 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
slovenčina (SK) (309.79 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
slovenščina (SL) (285.56 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
Suomi (FI) (242.32 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
svenska (SV) (238.95 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
VidPrevtyn Beta : EPAR - Risk-management-plan
English (EN) (8.41 MB - PDF)
First published: Last updated:
Product information
VidPrevtyn Beta : EPAR - Product information
English (EN) (1.33 MB - PDF)
First published: Last updated:
български (BG) (1.71 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
español (ES) (1.35 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
čeština (CS) (2.01 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
dansk (DA) (1.33 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
Deutsch (DE) (763.5 KB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
eesti keel (ET) (1.1 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
ελληνικά (EL) (2.41 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
français (FR) (1.94 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
hrvatski (HR) (1.34 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
íslenska (IS) (1.62 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
italiano (IT) (1.4 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
latviešu valoda (LV) (1.41 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
lietuvių kalba (LT) (1.36 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
magyar (HU) (1.88 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
Malti (MT) (1.75 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
Nederlands (NL) (997.84 KB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
norsk (NO) (1.31 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
polski (PL) (1.75 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
português (PT) (1.46 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
română (RO) (1.61 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
slovenčina (SK) (2.15 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
slovenščina (SL) (1.69 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
Suomi (FI) (1.53 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
svenska (SV) (1.52 MB - PDF)
First published: 10/11/2022Last updated: 20/03/2024
Latest procedure affecting product information:
II/0007/G
11/03/2024
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).
VidPrevtyn Beta : EPAR - All authorised presentations
English (EN) (90.38 KB - PDF)
First published: Last updated:
български (BG) (118.8 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
español (ES) (94.34 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
čeština (CS) (113.37 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
dansk (DA) (107.73 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
Deutsch (DE) (96.35 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
eesti keel (ET) (61.27 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
ελληνικά (EL) (116.16 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
français (FR) (107.82 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
hrvatski (HR) (87.38 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
íslenska (IS) (102.35 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
italiano (IT) (90.96 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
latviešu valoda (LV) (89.83 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
lietuvių kalba (LT) (83.47 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
magyar (HU) (85.1 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
Malti (MT) (171.03 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
Nederlands (NL) (88.94 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
norsk (NO) (110.72 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
polski (PL) (125.12 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
português (PT) (176.9 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
română (RO) (98.92 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
slovenčina (SK) (88.21 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
slovenščina (SL) (139.29 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
Suomi (FI) (100.61 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
svenska (SV) (107.86 KB - PDF)
First published: 11/11/2022Last updated: 20/03/2024
Product details
- Name of medicine
- VidPrevtyn Beta
- Active substance
- SARS-CoV-2 prefusion Spike delta TM protein, recombinant (B.1.351 strain)
- International non-proprietary name (INN) or common name
- COVID-19 Vaccine (recombinant, adjuvanted)
- Therapeutic area (MeSH)
- COVID-19 virus infection
- Anatomical therapeutic chemical (ATC) code
- J07BN04
Pharmacotherapeutic group
VaccinesTherapeutic indication
VidPrevtyn Beta is indicated as a booster for active immunisation to prevent COVID-19 in adults who have previously received an mRNA or adenoviral vector COVID-19 vaccine (see sections 4.2 and 5.1 in product information document).
The use of this vaccine should be in accordance with official recommendations.
Authorisation details
- EMA product number
- EMEA/H/C/005754
- Marketing authorisation holder
- Sanofi Pasteur
14 Espace Henry Vallée
69007 Lyon
France - Opinion adopted
- 10/11/2022
- Marketing authorisation issued
- 10/11/2022
- Withdrawal of marketing authorisation
- 18/03/2024
- Revision
- 4
Assessment history
VidPrevtyn Beta : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (229.51 KB - PDF)
First published: Last updated:
VidPrevtyn Beta-H-C-PSUSA-00011035-202305 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Reference Number: EMA/67397/2024
English (EN) (171.96 KB - PDF)
First published: Last updated:
VidPrevtyn Beta : EPAR - Public assessment report
AdoptedReference Number: EMA/893684/2022
English (EN) (12.98 MB - PDF)
First published: Last updated:
CHMP summary of positive opinion for VidPrevtyn Beta
AdoptedReference Number: EMA/867425/2022
English (EN) (290.09 KB - PDF)
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Safety updates
COVID-19 vaccines - Safety update: 8 December 2022
Reference Number: Rev. 2
English (EN) (239.73 KB - PDF)
First published: Last updated:
VidPrevtyn Beta: Periodic safety update report assessment 10 May 2023 to 9 November 2023
English (EN) (7.97 MB - PDF)
First published:
VidPrevtyn Beta: Periodic safety update report assessment 10 November 2022 to 9 May 2023
English (EN) (13.77 MB - PDF)
First published: Last updated:
News on VidPrevtyn Beta
More information on VidPrevtyn Beta
Public statement on VidPrevtyn Beta: Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/585020/2023
English (EN) (122.74 KB - PDF)
First published:
More information on VidPrevtyn Beta
This page was last updated on