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.
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 |
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)
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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 |
19
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Date of issue of marketing authorisation valid throughout the European Union |
04/12/2013
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Contact address |
Product information
27/07/2020 Fluenz Tetra - EMEA/H/C/002617 - II/0101
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
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Influenza vaccines
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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.