Supemtek
Quadrivalent influenza vaccine (recombinant, prepared in cell culture)
Table of contents
Overview
Supemtek is a vaccine used to protect adults 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.
Supemtek contains proteins of four different 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.
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Supemtek : EPAR - Medicine overview (PDF/132.83 KB)
First published: 25/11/2020
EMA/506492/2020 -
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Supemtek : EPAR - Risk-management-plan summary (PDF/98.56 KB)
First published: 25/11/2020
Authorisation details
Product details | |
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Name |
Supemtek
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Agency product number |
EMEA/H/C/005159
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Active substance |
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International non-proprietary name (INN) or common name |
Quadrivalent influenza vaccine (recombinant, prepared in cell culture)
|
Therapeutic area (MeSH) |
Influenza, Human
|
Anatomical therapeutic chemical (ATC) code |
J07BB02
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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 | |
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Marketing-authorisation holder |
Sanofi Pasteur
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Revision |
3
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Date of issue of marketing authorisation valid throughout the European Union |
16/11/2020
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Contact address |
14 Espace Henry Vallée |
Product information
20/07/2023 Supemtek - EMEA/H/C/005159 - II/0011/G
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Supemtek is indicated for active immunization for the prevention of influenza disease in adults.
Supemtek should be used in accordance with official recommendations.