Supemtek
Authorised
This medicine is authorised for use in the European Union
trivalent influenza vaccine (recombinant, prepared in cell culture)
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Supemtek is a vaccine used to protect adults and children from 9 years of age against influenza (flu).
Influenza is mainly caused by two types of influenza virus, known as influenza A and B, which circulate as different strains and subtypes that change over time.
Supemtek contains proteins from three different influenza A and B virus strains (one A(H1N1) strain, one A(H3N2) strain and one B strain), chosen based on the official recommendation for the annual flu season.
The vaccine can only be obtained with a prescription.
Supemtek 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 should be used according to official recommendations issued at national level by public health bodies.
For more information about using Supemtek, see the package leaflet or contact your doctor or pharmacist.
Supemtek is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Supemtek contains proteins from the surface of three different strains of the flu virus.
When a person is given the vaccine, the immune system will treat the virus proteins as ‘foreign’ and make defences against them. If, later on, the person comes into contact with the flu virus, the immune system will recognise the virus proteins and be prepared to defend the body against the virus. This will help to protect against flu.
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 will be updated annually according to WHO and EU recommendations.
The company that developed the vaccine provided data from 3 main studies carried out with a similar influenza vaccine called Supemtek Tetra. This vaccine contains proteins from the 3 virus strains used in Supemtek, as well as from an additional influenza B strain. Supemtek Tetra has an overlapping composition and is made using the same process as Supemtek.
The first study found that Supemtek Tetra was more effective at preventing flu in adults aged 50 or above than a comparator flu vaccine that also protects against 4 strains. The study, which involved around 8,600 adults aged 50 or above, found that 2.2% (96 out of 4,303) of people given Supemtek Tetra developed flu-like illness compared with 3.2% (138 out of 4,301) of those given the comparator. This means that Supemtek Tetra is 30% more effective at preventing flu than the comparator vaccine.
The second study involved 1,350 adults aged 18 to 49 who received either Supemtek Tetra or the comparator vaccine. The study evaluated the immune response triggered by the vaccines based on the level of antibodies against the flu strains targeted by the vaccines. The results showed that the immune response to Supemtek Tetra was comparable to that seen with the comparator vaccine for 3 of the 4 strains.
The third study involved 641 children aged 9 and above and 658 adults aged 18 to 49. Following vaccination with Supemtek Tetra, the immune response in children was comparable to that seen in adults for all 4 virus strains targeted by the vaccine.
For the full list of side effects and restrictions with Supemtek, see the package leaflet.
Based on data from the main studies, the most common side effects with Supemtek in adults (which may affect more than 1 in 10 people) are expected to include tenderness and pain at the site of injection, headache, tiredness and, in adults below 50 years of age, muscle pain.
The most common side effects with Supemtek in children aged 9 to 17 (which may affect more than 1 in 10 children) include pain at the injection site, muscle pain, headache and feeling generally unwell.
Supemtek must not be used in people who are allergic to the active substance, any of the other ingredients or substances used during the manufacturing process that may be present in the vaccine in trace amounts such as octylphenol ethoxylate.
The efficacy of Supemtek in people aged 9 years and above is supported by studies with a similar vaccine, Supemtek Tetra. These studies showed that Supemtek Tetra is effective at preventing flu in people aged 50 or above and at triggering an immune response to protect against flu in younger adults and children over 9 years of age. As Supemtek has a similar composition and is made using the same process as Supemtek Tetra, it is expected to behave in the same way as Supemtek Tetra. In terms of safety, side effects with Supemtek are expected to be similar to those observed with Supemtek Tetra and are mostly mild to moderate in severity.
The European Medicines Agency therefore decided that Supemtek’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 have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Supemtek are continuously monitored. Suspected side effects reported with Supemtek are carefully evaluated and any necessary action taken to protect patients.
Supemtek received a marketing authorisation valid throughout the EU on 30 March 2026.
Product information
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).
Product details
- Name of medicine
- Supemtek
- Active substance
- A/California/07/2009 (H1N1)pdm09-like strain (A/California/07/2009)
- A/Texas/50/2012 (H3N2)-like strain (A/Texas/50/2012)
- B/Brisbane/60/2008-like strain (B/Brisbane/60/2008)
- International non-proprietary name (INN) or common name
- trivalent influenza vaccine (recombinant, prepared in cell culture)
- Therapeutic area (MeSH)
- Influenza, Human
- Anatomical therapeutic chemical (ATC) code
- J07BB02
Pharmacotherapeutic group
VaccinesTherapeutic indication
Supemtek is indicated for active immunisation for the prevention of influenza disease in adults and children from 9 years of age and older.
Supemtek should be used in accordance with official recommendations.
News on Supemtek
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