Arepanrix

RSS

pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Arepanrix has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 25/10/2011

Authorisation details

Product details
Name
Arepanrix
Agency product number
EMEA/H/C/001201
Active substance
split influenza virus, inactivated, containing antigen* : A/California/7/2009 (H1N1)v like strain (X-179A)* produced in eggs
International non-proprietary name (INN) or common name
pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Therapeutic area (MeSH)
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
Anatomical therapeutic chemical (ATC) code
J07BB02
Conditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Publication details
Marketing-authorisation holder
GlaxoSmithKline Biologicals S.A.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
23/03/2010
Contact address
89, rue de l'Institut
BE-1330 Rixensart
Belgium

Product information

13/08/2010 Arepanrix - EMEA/H/C/001201 - IB/0005/G

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

Influenza 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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