Fluenz

RSS

influenza vaccine (intranasal, live attenuated)

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Fluenz has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 03/12/2014

Authorisation details

Product details
Name
Fluenz
Agency product number
EMEA/H/C/001101
Active substance
Reassortant influenza virus (live attenuated) of the following strains:A/California/7/2009 (H1N1)pdm09 like strain, A/Victoria/361/2011 (H3N2) like strain, B/Massachusetts/2/2012 like strain
International non-proprietary name (INN) or common name
influenza vaccine (intranasal, live attenuated)
Therapeutic area (MeSH)
  • Influenza, Human
  • Immunization
Anatomical therapeutic chemical (ATC) code
J07BB03
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
MedImmune LLC
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
27/01/2011
Contact address
Lagelandseweg 78
NL-6545 CG Nijmegen
The Netherlands

Product information

21/10/2013 Fluenz - EMEA/H/C/001101 - IAIN/0056

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 24 months to less than 18 years of age.

The use of Fluenz should be based on official recommendations.

Assessment history

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