Fluenz Tetra

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influenza vaccine (live attenuated, nasal)

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

Overview

This is a summary of the European public assessment report (EPAR) for Fluenz Tetra. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Fluenz Tetra.

For practical information about using Fluenz Tetra, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 20/09/2018

Authorisation details

Product details
Name
Fluenz Tetra
Agency product number
EMEA/H/C/002617
Active substance
reassortant influenza virus (live attenuated) of the following four strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Bolivia/559/2013, MEDI 255962)A/Hong Kong/4801/2014 (H3N2) - like strain(A/New Caledonia/71/2014, MEDI 263122)B/Brisbane/60/2008 - like strain(B/Brisbane/60/2008, MEDI 228030)B/Phuket/3073/2013 - like strain(B/Phuket/3073/2013, MEDI 254977)
International non-proprietary name (INN) or common name
influenza vaccine (live attenuated, nasal)
Therapeutic area (MeSH)
Influenza, Human
Anatomical therapeutic chemical (ATC) code
J07BB03
Additional 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
AstraZeneca AB
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
03/12/2013
Contact address
SE-151 85 Södertälje
Sweden

Product information

28/08/2018 Fluenz Tetra - EMEA/H/C/002617 - II/0082

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

  • Influenza vaccines
  • influenza live attenuated

Therapeutic indication

Prophylaxis of influenza in children and adolescents 24 months to less than 18 years of age. The use of Fluenz Tetra should be based on official recommendations.

Assessment history

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