Flucelvax Tetra

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influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

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

Overview

Flucelvax Tetra is a vaccine used to protect adults and children from 2 years of age against influenza (flu).

Influenza is mainly caused by two kinds of influenza virus, known as influenza A and B. Each of these circulate as different strains and subtypes, which change over time.

Flucelvax Tetra contains proteins from four different inactivated influenza A and B virus strains (type A-H1N1, type A-H3N2 and two type B strains), chosen based on the official recommendation for the annual flu season. 

This EPAR was last updated on 01/08/2022

Authorisation details

Product details
Name
Flucelvax Tetra
Agency product number
EMEA/H/C/004814
Active substance
A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type)
International non-proprietary name (INN) or common name
influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
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
11
Date of issue of marketing authorisation valid throughout the European Union
12/12/2018
Contact address

Paasheuvelweg 28
1105 BJ Amsterdam
The Netherlands

Product information

27/07/2022 Flucelvax Tetra - EMEA/H/C/004814 - II/0027

Other EU languages available icon 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:

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

influenza, inactivated, split virus or surface antigen

Therapeutic indication

Prophylaxis of influenza in adults and children from 2 years of age.

Flucelvax Tetra should be used in accordance with official recommendations.

Assessment history

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