Flucelvax Tetra
influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Table of contents
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.
-
List item
Flucelvax Tetra : EPAR - Medicine overview (PDF/126.78 KB)
First published: 20/12/2018
Last updated: 18/11/2020
EMA/510023/2020 -
-
List item
Flucelvax Tetra : EPAR - Risk-management-plan summary (PDF/94.54 KB)
First published: 20/12/2018
Last updated: 18/11/2020
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/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 |
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 |
12/12/2018
|
Contact address |
Product information
22/10/2020 Flucelvax Tetra - EMEA/H/C/004814 - II/0013
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Therapeutic indication
Prophylaxis of influenza in adults and children from 2 years of age.
Flucelvax Tetra should be used in accordance with official recommendations.