Flucelvax Tetra


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

This medicine is authorised for use in the European Union.


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 18/11/2020

Authorisation details

Product details
Flucelvax Tetra
Agency product number
Active substance
Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Hawaii/70/2019 (H1N1)pdm09-like strain (A/Nebraska/14/2019, wild type); A/Hong Kong/45/2019 (H3N2)-like strain (A/Delaware/39/2019, wild type); B/Washington/02/2019-like strain (B/Darwin/7/2019, 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
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.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Paasheuvelweg 28
1105 BJ Amsterdam
The Netherlands

Product information

22/10/2020 Flucelvax Tetra - EMEA/H/C/004814 - II/0013


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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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