VidPrevtyn Beta

Withdrawn

This medicine's authorisation has been withdrawn

COVID-19 Vaccine (recombinant, adjuvanted)

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The marketing authorisation for Vidprevtyn Beta has been withdrawn at the request of the marketing-authorisation holder.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

VidPrevtyn Beta : EPAR - Risk-management-plan

Product information

VidPrevtyn Beta : EPAR - Product information

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

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

Vaccines

Therapeutic 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

Changes since initial authorisation of medicine

VidPrevtyn Beta : EPAR - Procedural steps taken and scientific information after authorisation

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

Initial marketing authorisation documents

VidPrevtyn Beta : EPAR - Public assessment report

AdoptedReference Number: EMA/893684/2022

CHMP summary of positive opinion for VidPrevtyn Beta

AdoptedReference Number: EMA/867425/2022