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 10/02/2022

Authorisation details

Product details
Name
Fluenz Tetra
Agency product number
EMEA/H/C/002617
Active substance
A/Victoria/2570/2019 (H1N1)pdm09 like strain (A/Victoria/1/2020, MEDI 340505) A/Cambodia/e0826360/2020 (H3N2) - like strain (A/Tasmania/503/2020, MEDI 339018) B/Washington/02/2019 like strain (B/Washington/02/2019, MEDI 323797) B/Phuket/3073/2013 like strain (B/Phuket/3073/2013, MEDI 306444)
International non-proprietary name (INN) or common name
influenza vaccine (live attenuated, nasal)
Therapeutic area (MeSH)
Influenza, Human
Anatomical therapeutic chemical (ATC) code
J07BB03
Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
04/12/2013
Contact address
SE-151 85 Södertälje
Sweden

Product information

03/02/2022 Fluenz Tetra - EMEA/H/C/002617 - N/0114

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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