Pandemrix

RSS

influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (x-179a)

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Pandemrix has expired following the marketing-authorisation holder’s decision not to apply for a renewal.

This EPAR was last updated on 10/06/2016

Authorisation details

Product details
Name
Pandemrix
Agency product number
EMEA/H/C/000832
Active substance
split influenza virus inactivated, containing antigen equivalent to A/California/07/2009 (H1N1)-derived strain used NYMC X-179A
International non-proprietary name (INN) or common name
influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (x-179a)
Therapeutic area (MeSH)
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
Anatomical therapeutic chemical (ATC) code
J07BB02
Publication details
Marketing-authorisation holder
GlaxoSmithKline Biologicals S.A.
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
20/05/2008
Contact address
Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Product information

28/04/2016 Pandemrix - EMEA/H/C/000832 - II/0079

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 caused by A (H1N1)v 2009 virus. Pandemrix should only be used if the recommended annual seasonal trivalent / quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see sections 4.4 and 4.8).

Pandemrix should be used in accordance with Official Guidance.

Assessment history

Changes since initial authorisation of medicine

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