Aflunov

RSS

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

Authorised
This medicine is authorised for use in the European Union.

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).

This EPAR was last updated on 11/11/2019

Authorisation details

Product details
Name
Aflunov
Agency product number
EMEA/H/C/002094
Active substance
influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23)
International non-proprietary name (INN) or common name
prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Therapeutic area (MeSH)
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
Anatomical therapeutic chemical (ATC) code
J07BB02
Publication details
Marketing-authorisation holder
Seqirus S.r.l. 
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
28/11/2010
Contact address

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

Product information

22/10/2019 Aflunov - EMEA/H/C/002094 - IAIN/0054

Contents

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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.

Assessment history

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