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

This medicine is now withdrawn from use in the European Union.


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
Agency product number
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)
Therapeutic area (MeSH)
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
GlaxoSmithKline Biologicals S.A.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Rue de l'Institut, 89
B-1330 Rixensart

Product information

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

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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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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