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 9 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 06/08/2019

Authorisation details

Product details
Name
Flucelvax Tetra
Agency product number
EMEA/H/C/004814
Active substance
Influenza virus surface antigens (haemagglutinin and neuraminidase)* , inactivated, of the following strains: A/xxxxx (H3N2)-like strain (reassortant used)/ A/xxxxx H1N1- like strain (reassortant used)/ B/xxxxx (Yamagata Lineage) – like strain (reassortant used)/ B/xxxxx (Victoria Lineage) – like strain (reassortant used)
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
2
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

27/06/2019 Flucelvax Tetra - EMEA/H/C/004814 - II/0003

Contents

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Pharmacotherapeutic group

influenza, inactivated, split virus or surface antigen

Therapeutic indication

Prophylaxis of influenza in adults and children from 9 years of age.
Flucelvax Tetra should be used in accordance with official recommendations.

Assessment history

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