pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)

This medicine is authorised for use in the European Union.


Foclivia is a vaccine used in adults to protect against flu when a ‘pandemic’ has been officially declared by the World Health Organization (WHO) or the European Union (EU). A flu pandemic occurs when a new type (strain) of flu virus can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world. Foclivia would be given according to official recommendations.

Foclivia contains some parts of inactivated (killed) influenza (flu) virus. It contains a flu strain called A/Vietnam/1194/2004 (H5N1).

This EPAR was last updated on 04/12/2019

Authorisation details

Product details
Agency product number
Active substance
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1)
International non-proprietary name (INN) or common name
pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Therapeutic area (MeSH)
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
Anatomical therapeutic chemical (ATC) code
Exceptional circumstancesExceptional 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
Seqirus S.r.l. 
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Via del Pozzo 3/A
S. Martino
53035 Monteriggioni (SI)

Product information

22/10/2019 Foclivia - EMEA/H/C/001208 - IAIN/0049


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Pharmacotherapeutic group


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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