Intanza

RSS

influenza vaccine (split virion, inactivated)

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Intanza has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 04/09/2018

Authorisation details

Product details
Name
Intanza
Agency product number
EMEA/H/C/000957
Active substance
influenza virus (inactivated, split) of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type)
International non-proprietary name (INN) or common name
influenza vaccine (split virion, inactivated)
Therapeutic area (MeSH)
  • Influenza, Human
  • Immunization
Anatomical therapeutic chemical (ATC) code
J07BB02
Publication details
Marketing-authorisation holder
Sanofi Pasteur Europe
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
24/02/2009
Contact address
2 Avenue Pont Pasteur
69007 Lyon
France

Product information

07/09/2017 Intanza - EMEA/H/C/000957 - II/0054

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

Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications.
The use of Intanza should be based on official recommendations.

Assessment history

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