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.
-
List item
Fluad Tetra : EPAR - Medicine overview (PDF/127.38 KB)
First published: 29/05/2020
EMA/169326/2020 -
-
List item
Fluad Tetra : EPAR - Risk-management-plan summary (PDF/151.84 KB)
First published: 29/05/2020
Authorisation details
Product details | |
---|---|
Name |
Fluad Tetra
|
Agency product number |
EMEA/H/C/004993
|
Active substance |
A/Victoria/2570/2019 (H1N1)pdm09 like strain (A/Victoria/2570/2019 IVR‐215) A/Darwin/9/2021 (H3N2) like strain (A/Darwin/6/2021 IVR-227) B/Austria/1359417/2021 like strain (B/Austria/1359417/2021 BVR-26) B/Phuket/3073/2013 like strain (B/Phuket/3073/2013 BVR‐1B)
|
International non-proprietary name (INN) or common name |
influenza vaccine (surface antigen, inactivated, adjuvanted)
|
Therapeutic area (MeSH) |
Influenza, Human
|
Anatomical therapeutic chemical (ATC) code |
J07BB02
|
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 | |
---|---|
Marketing-authorisation holder |
Seqirus Netherlands B.V.
|
Revision |
6
|
Date of issue of marketing authorisation valid throughout the European Union |
20/05/2020
|
Contact address |
Paasheuvelweg 28 |
Product information
17/05/2023 Fluad Tetra - EMEA/H/C/004993 - N/0044
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
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.