Pandemic Influenza Vaccine H5N1 Baxter AG

RSS

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

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 18/01/2019

Authorisation details

Product details
Name
Pandemic Influenza Vaccine H5N1 Baxter AG
Agency product number
EMEA/H/C/001200
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
Exceptional circumstancesExceptional 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.

Publication details
Marketing-authorisation holder
Ology Bioservices Ireland LTD
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
16/10/2009
Contact address

Wilton Park House
Wilton Place
Dublin 2
D02P447
Ireland

Product information

24/03/2017 Pandemic Influenza Vaccine H5N1 Baxter AG - EMEA/H/C/001200 - T/0026

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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