Vepacel

Withdrawn

This medicine's authorisation has been withdrawn

prepandemic influenza vaccine (H5N1) (whole virion, inactivated,prepared in cell culture)

Overview

On 24th September 2020, the European Commission withdrew the marketing authorisation for Vepacel (prepandemic influenza vaccine H5N1 (whole virion, vero cell derived, inactivated)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Ology Bioservices Ireland Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Vepacel was granted marketing authorisation in the EU on 17 February 2012 for prophylaxis of H5N1 subtype of influenza A. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2017. The product had not been marketed in the EU. 

The European Public Assessment Report (EPAR) for Vepacel is updated to indicate that the marketing authorisation is no longer valid.

Vepacel : EPAR - Summary for the public

Reference Number: EMA/991112/2011

Product information

Vepacel : EPAR - Product Information

Vepacel : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Vepacel
• Active substance:
  Influenza virus (whole virion, inactivated), containing antigen of: A/Vietnam/1203/2004 (H5N1)
• International non-proprietary name (INN) or common name:
  prepandemic influenza vaccine (H5N1) (whole virion, inactivated,prepared in cell culture)
• Therapeutic area (MeSH):
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
• Anatomical therapeutic chemical (ATC) code:
  J07BB01

Pharmacotherapeutic group

Influenza vaccines

Therapeutic indication

Active immunisation against H5N1 subtype of influenza A virus.

This indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with H5N1 subtype strains.

Vepacel should be used in accordance with Official guidance.

Authorisation details

• EMA product number:
  EMEA/H/C/002089
• Marketing authorisation holder:
  Ology Bioservices Ireland LTD

  2 Shelbourne Buildings; Crampton Avenue; Dublin 4; D04 W346; Ireland

• Marketing authorisation issued:
  17/02/2012
• Revision:
  9

Assessment history

Changes since initial authorisation of medicine

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

Vepacel-H-C-2089-P46-0008 : EPAR - Assessment Report

Adopted Reference Number: EMA/645732/2014

Vepacel : EPAR - Paediatric investigation plan compliance statement

Reference Number: EMA/59759/2014

Vepacel-H-C-2089-II-0007 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/59623/2014

CHMP post-authorisation summary of positive opinion for Vepacel

Adopted Reference Number: EMA/CHMP/648050/2013

Initial marketing authorisation documents

Vepacel : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Vepacel

Adopted Reference Number: EMA/CHMP/932537/2011