Daronrix

RSS

Pandemic influenza vaccine (H5N1) (whole virion, inactivated, adsorbed)

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Daronrix has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.

This EPAR was last updated on 01/07/2013

Authorisation details

Product details
Name
Daronrix
Agency product number
EMEA/H/C/000706
Active substance
Whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)* produced in eggs
International non-proprietary name (INN) or common name
Pandemic influenza vaccine (H5N1) (whole virion, inactivated, adsorbed)
Therapeutic area (MeSH)
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
Anatomical therapeutic chemical (ATC) code
J07BB01
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.

Publication details
Marketing-authorisation holder
GlaxoSmithKline Biologicals S.A.
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
20/03/2007
Contact address
Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Product information

20/03/2007 Daronrix - EMEA/H/C/000706 -

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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