Fluad Tetra

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influenza vaccine (surface antigen, inactivated, adjuvanted)

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 02/08/2022

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 monitoringAdditional 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
4
Date of issue of marketing authorisation valid throughout the European Union
20/05/2020
Contact address

Paasheuvelweg 28
1105 BJ Amsterdam
The Netherlands

Product information

22/07/2022 Fluad Tetra - EMEA/H/C/004993 - II/0030

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

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.

Assessment history

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