Pandemic Influenza Vaccine H5N1 Baxter AG

Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

On 11 September 2023 the European Commission withdrew the marketing authorisation for Pandemic Influenza Vaccine H5N1 Baxter (pandemic influenza vaccine H5N1 (whole virion, inactivated, prepared in cell culture)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Resilience Biomanufacturing Ireland Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Pandemic Influenza Vaccine H5N1 Baxter was granted marketing authorisation in the EU on 16 October 2009 for prophylaxis of pandemic influenza. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2014. 

The European Public Assessment Report (EPAR) for Pandemic Influenza Vaccine H5N1 Baxter is updated to indicate that the marketing authorisation is no longer valid.

Pandemic Influenza Vaccine H5N1 Baxter : EPAR - Summary for the public

Product information

Pandemic Influenza Vaccine H5N1 Baxter : EPAR - Product Information

Pandemic Influenza Vaccine H5N1 Baxter : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Pandemic Influenza Vaccine H5N1 Baxter AG
• Active substance:
  influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1)
• International non-proprietary name (INN) or common name:
  pandemic 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

Vaccines

Therapeutic indication

Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.

Authorisation details

• EMA product number:
  EMEA/H/C/001200
• Exceptional circumstances:

  This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

• Marketing authorisation holder:
  Resilience Biomanufacturing Ireland Limited

  Resilience Biomanufacturing Ireland Limited; Shelbourne Buildings 2; Cramptom Avenue; Dublin 4; D04 W3V6; IRELAND

• Opinion adopted:
  23/08/2009
• Marketing authorisation issued:
  16/10/2009
• Withdrawal of marketing authorisation:
  11/09/2023
• Revision:
  8

Assessment history

Changes since initial authorisation of medicine

Pandemic Influenza Vaccine H5N1 Baxter : EPAR - Procedural steps taken and scientific information after authorisation

Pandemic Influenza Vaccine H5N1-H-C-1200-P46-0020 : EPAR - Assessment Report

Adopted Reference Number: EMA/770863/2014

Pandemic Influenza Vaccine H5N1 Baxter-H-C-1200-II-0015 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/65558/2014

Pandemic Influenza Vaccine H5N1 Baxter : EPAR - Paediatric investigation plan compliance statement

Reference Number: EMA/65572/2014

CHMP post-authorisation summary of positive opinion for Pandemic influenza vaccine H5N1 Baxter

Adopted Reference Number: EMA/CHMP/648055/2013

Initial marketing authorisation documents

Pandemic Influenza Vaccine H5N1 Baxter : EPAR - Public assessment report

Committee for medicinal products for human use, summary of positive opinion for Pandemic Influenza Vaccine H5N1 Baxter

Reference Number: EMEA/CHMP/446619/2009