Foclivia
pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Table of contents
Overview
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).
Authorisation details
Product details | |
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Name |
Foclivia
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Agency product number |
EMEA/H/C/001208
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Active substance |
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1)
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International non-proprietary name (INN) or common name |
pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
J07BB02
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Exceptional 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 | |
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Marketing-authorisation holder |
Seqirus S.r.l.
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Revision |
12
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Date of issue of marketing authorisation valid throughout the European Union |
18/10/2009
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Contact address |
Via del Pozzo 3/A |
Product information
31/03/2022 Foclivia - EMEA/H/C/001208 - WS/2226/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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
Vaccines
Therapeutic indication
Prophylaxis of influenza in an officially declared pandemic situation.
Pandemic influenza vaccine should be used in accordance with official guidance.