Fluenz

influenza vaccine (intranasal, live attenuated)

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The marketing authorisation for Fluenz has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Fluenz : EPAR - Summary for the public BG = bălgarski 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public ES = español 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public CS = čeština 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public DA = dansk 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public DE = Deutsch 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public ET = eesti keel 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public EL = elliniká 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public EN = English 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public FR = français 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public IT = italiano 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public LV = latviešu valoda 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public LT = lietuvių kalba 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public HU = magyar 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public MT = Malti 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public NL = Nederlands 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public PL = polski 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public PT = português 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public RO = română 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public SK = slovenčina 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public SL = slovenščina 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public FI = suomi 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public SV = svenska 17/03/2011 03/12/2014
Fluenz : EPAR - Summary for the public HR = Hrvatski 17/03/2011 03/12/2014

This EPAR was last updated on 03/12/2014 .

Authorisation details

Product details

Product details for Fluenz
NameFluenz
Agency product numberEMEA/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 Influenza, HumanImmunization
Anatomical therapeutic chemical (ATC) code J07BB03
Additional monitoring

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

Publication details

Publication details for Fluenz
Marketing-authorisation holder

MedImmune LLC

Revision4
Date of issue of marketing authorisation valid throughout the European Union27/01/2011

Contact address:

MedImmune LLC
Lagelandseweg 78
NL-6545 CG Nijmegen
The Netherlands

Product information

Product information

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

Name Language First published Last updated
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - Product Information HR = Hrvatski 17/03/2011 03/12/2014

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.


Name Language First published Last updated
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014
Fluenz : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011 03/12/2014

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Fluenz-H-C-1101-P46-28.1 : EPAR - Assessment Report HR = Hrvatski 03/12/2014  
Fluenz-H-C-1101-P46-27 : EPAR - Assessment Report HR = Hrvatski 03/12/2014  
Fluenz : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 27/11/2012 03/12/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Fluenz : EPAR - Public assessment report HR = Hrvatski 17/03/2011 03/12/2014
CHMP summary of positive opinion for Fluenz HR = Hrvatski 22/10/2010 03/12/2014

Withdrawn

This medicine is now withdrawn from use in the European Union