Fluenz Tetra
influenza vaccine (live attenuated, nasal)
Table of contents
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.
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Fluenz Tetra : EPAR - Summary for the public (PDF/77.06 KB)
First published: 17/12/2013
Last updated: 05/09/2016 -
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Fluenz Tetra : EPAR - Risk-management-plan (PDF/111.27 KB)
First published: 07/08/2023
Authorisation details
Product details | |
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Name |
Fluenz Tetra
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Agency product number |
EMEA/H/C/002617
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Active substance |
A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) / A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020, MEDI 340505) / B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) / B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444)
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International non-proprietary name (INN) or common name |
influenza vaccine (live attenuated, nasal)
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Therapeutic area (MeSH) |
Influenza, Human
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Anatomical therapeutic chemical (ATC) code |
J07BB03
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Publication details | |
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Marketing-authorisation holder |
AstraZeneca AB
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Revision |
24
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Date of issue of marketing authorisation valid throughout the European Union |
04/12/2013
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Contact address |
SE-151 85 Södertälje
Sweden |
Product information
28/07/2023 Fluenz Tetra - EMEA/H/C/002617 - II/0132
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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Influenza vaccines
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Influenza, live attenuated
Therapeutic indication
Prophylaxis of influenza in children and adolescents from 24 months to less than 18 years of age. The use of Fluenz Tetra should be based on official recommendations.