Aflunov
zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Table of contents
Overview
Aflunov is a vaccine used in adults to protect against flu caused by the H5N1 (‘bird flu’) strain of the influenza A virus. Aflunov contains parts of influenza (flu) viruses that have been inactivated. Aflunov contains a flu strain called A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1).
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List item
Aflunov : EPAR - Summary for the public (PDF/112.36 KB)
First published: 24/01/2011
Last updated: 05/08/2019
EMA/777825/2012 -
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Aflunov : EPAR - Risk-management-plan summary (PDF/293.53 KB)
First published: 30/07/2019
Authorisation details
Product details | |
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Name |
Aflunov
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Agency product number |
EMEA/H/C/002094
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Active substance |
influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23)
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International non-proprietary name (INN) or common name |
zoonotic 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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Publication details | |
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Marketing-authorisation holder |
Seqirus S.r.l.
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Revision |
15
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Date of issue of marketing authorisation valid throughout the European Union |
28/11/2010
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Contact address |
Via del Pozzo 3/A |
Product information
30/09/2022 Aflunov - EMEA/H/C/002094 - IB/0080
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
Active immunisation against H5N1 subtype of influenza-A virus.
This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/turkey/Turkey/1/05 (H5N1)-like strain.
Aflunov should be used in accordance with official recommendations.