Fluad Tetra
influenza vaccine (surface antigen, inactivated, adjuvanted)
Table of contents
Overview
Fluad Tetra is a vaccine used to protect people aged from 65 years against influenza (flu).
Flu is caused mainly by two types of influenza virus, known as influenza A and B. Each of these circulate as different strains, which change over time.
Fluad Tetra will contain proteins from four different inactivated influenza A and B virus strains (two strains of type A influenza virus of the subtypes H1N1 and H3N2 and two type B strains). They are chosen according to the official recommendation for the annual flu season.
The vaccine also contains an adjuvant, which helps to improve the vaccine's effectiveness. The viruses used for producing Fluad Tetra are grown in fertilized hens’ eggs.
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Fluad Tetra : EPAR - Medicine overview (PDF/127.38 KB)
First published: 29/05/2020
EMA/169326/2020 -
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Fluad Tetra : EPAR - Risk-management-plan summary (PDF/151.84 KB)
First published: 29/05/2020
Authorisation details
Product details | |
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Name |
Fluad Tetra
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Agency product number |
EMEA/H/C/004993
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Active substance |
Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/(H1N1)-like virus antigen / A/(H3N2)-like virus antigen / B (victoria lineage)-like virus antigen B (yamagata lineage)-like virus antigen
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International non-proprietary name (INN) or common name |
influenza vaccine (surface antigen, inactivated, adjuvanted)
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Therapeutic area (MeSH) |
Influenza, Human
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Anatomical therapeutic chemical (ATC) code |
J07BB02
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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 | |
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Marketing-authorisation holder |
Seqirus Netherlands B.V.
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Date of issue of marketing authorisation valid throughout the European Union |
20/05/2020
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Contact address |
Product information
20/05/2020 Fluad Tetra - EMEA/H/C/004993 -
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
Vaccines
Therapeutic indication
Prophylaxis of influenza in the elderly (65 years of age and older).
Fluad Tetra should be used in accordance with official recommendations.