Aflunov

RSS

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

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

Overview

This is a summary of the European public assessment report (EPAR) for Aflunov. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aflunov.

This EPAR was last updated on 10/07/2017

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
8
Date of issue of marketing authorisation valid throughout the European Union
28/11/2010
Contact address
Seqirus S.r.l.
Via Fiorentina 1
I-53100
Siena
Italy

Product information

18/05/2017 Aflunov - EMEA/H/C/002094 - IA/0037

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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