influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)

This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Focetria has been expired following the marketing-authorisation holder's decision not to apply for a renewal.

This EPAR was last updated on 11/02/2016

Authorisation details

Product details
Agency product number
Active substance
Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/California/7/2009 (H1N1)-derived strain used NYMC X-181
International non-proprietary name (INN) or common name
influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
Therapeutic area (MeSH)
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Novartis Vaccines and Diagnostics S.r.l.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Via Fiorentina, 1
IT-53100 Siena

Product information

15/01/2015 Focetria - EMEA/H/C/000710 - PSUV/0033

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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 (H1N1v) 2009 virus.

Focetria should be used in accordance with official guidance.

Assessment history

Changes since initial authorisation of medicine

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