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Withdrawn

This medicine's authorisation has been withdrawn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

The marketing authorisation for Pandemic Influenza Vaccine H5N1 Baxter has been withdrawn at the request of the marketing-authorisation holder.

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

Product information

Pandemic Influenza Vaccine H5N1 Baxter : EPAR - Product Information

Latest procedure affecting product information: IAIN/0032

01/02/2023

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).

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

• Marketing authorisation issued:
  16/10/2009
• 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

AdoptedReference Number: EMA/770863/2014

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

AdoptedReference 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

AdoptedReference 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