Fluenz Tetra


influenza vaccine (live attenuated, nasal)

This medicine is authorised for use in the European Union.


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 06/08/2020

Authorisation details

Product details
Fluenz Tetra
Agency product number
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
Publication details
Marketing-authorisation holder
AstraZeneca AB
Date of issue of marketing authorisation valid throughout the European Union
Contact address
SE-151 85 Södertälje

Product information

27/07/2020 Fluenz Tetra - EMEA/H/C/002617 - II/0101


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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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