Supemtek Tetra (previously Supemtek) | European Medicines Agency (EMA)

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Overview

Supemtek Tetra 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 Tetra 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.

Supemtek Tetra is available as a solution for injection in a pre-filled syringe. The recommended dose is a single injection into a muscle, preferably in the upper arm.

The vaccine can only be obtained with a prescription and should be used according to official recommendations.

For more information about using Supemtek Tetra, see the package leaflet or contact your doctor or pharmacist.

Supemtek Tetra is a vaccine. Vaccines work by preparing the immune system (the body’s natural defences) to defend the body against a specific disease.

Supemtek Tetra contains proteins of four different strains of flu virus. When a person is given the vaccine, the immune system recognises the proteins as ‘foreign’ and makes defences against them. The immune system will then be able to respond more quickly when it is exposed to the virus. This will help to protect against the disease caused by the virus.

Each year, the World Health Organization (WHO) makes recommendations on which flu strains should be included in vaccines for the upcoming flu season in the northern hemisphere. The composition of Supemtek Tetra will be updated annually according to WHO and EU recommendations.

Supemtek Tetra was compared with another influenza vaccine that protects against the same four influenza A and B virus strains in 2 main studies involving over 10,000 people 18 years or more of age.

One study looked at the number of people who caught flu at least 14 days after receiving either vaccine; the other study assessed the ability of the vaccines to stimulate an immune response against influenza, by measuring the production of protective antibodies. Taken together, results of the two studies showed that Supemtek Tetra was at least as effective as the comparator vaccine at protecting against influenza in adults.

For the full list of side effects and restrictions of Supemtek Tetra, see the package leaflet.

The most common side effects with Supemtek Tetra (which may affect more than 1 in 10 people) include reactions at the site of injection such as tenderness and pain. In the studies, these side effects occurred within three days of vaccination and resolved without consequences.

Supemtek Tetra was shown to be as effective as a comparator vaccine at protecting against the 4 strains included in the vaccine. In terms of safety, side effects with Supemtek Tetra are similar to those observed with other influenza vaccines and are mostly mild to moderate in severity.

The European Medicines Agency therefore decided that Supemtek Tetra’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Supemtek Tetra have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Supemtek Tetra are continuously monitored. Side effects reported with Supemtek Tetra are carefully evaluated and any necessary action taken to protect patients.

Supemtek received a marketing authorisation valid throughout the EU on 16 November 2020.

The name of the medicine was changed to Supemtek Tetra on 24 January 2025.

English (EN)
(78.87 KB – PDF)

First published: 25/11/2020Last updated: 07/03/2025

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English (EN)
(98.56 KB – PDF)

First published: 25/11/2020

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Product information

English (EN)
(391.3 KB – PDF)

First published: 25/11/2020Last updated: 29/01/2025

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Latest procedure affecting product information:
VR/0000245320

24/01/2025

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).

English (EN)
(59.79 KB – PDF)

First published: 25/11/2020Last updated: 29/01/2025

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Product details

Name of medicine

Supemtek Tetra (previously Supemtek)

Active substance

Influenza A virus subtype H1N1 haemagglutinin, recombinant
Influenza A virus subtype H3N2 haemagglutinin, recombinant
Influenza B virus Victoria lineage haemagglutinin, recombinant
Influenza B virus Yamagata lineage haemagglutinin, recombinant

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

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.

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