Cenrifki
Authorised
This medicine is authorised for use in the European Union
tolebrutinib
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Cenrifki is a medicine used to treat adults with an advanced form of multiple sclerosis (MS) known as secondary progressive MS.
It is used in patients who have not had relapses in the last two years.
Cenrifki contains the active substance tolebrutinib.
The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the management of MS.
Cenrifki is available as tablets that should be taken once a day with a meal. The doctor will check the patient’s liver function before starting treatment. Treatment should not be started in patients who have abnormal results from these tests. Liver function should be monitored regularly after treatment has started; treatment may have to be temporarily interrupted or discontinued if liver function decreases.
For more information about using Cenrifki, see the package leaflet or contact your doctor or pharmacist.
In MS, the immune system (the body’s defences) attacks and damages the protective sheath around the nerves in the brain and spinal cord.
The active substance in Cenrifki, tolebrutinib, blocks the action of an enzyme known as Bruton's tyrosine kinase (BTK). BTK is important for the growth of a type of immune cells called B cells. In MS, B cells play a key role in driving inflammation in the central nervous system by activating immune responses and producing substances that damage nerve cells and their protective myelin sheath. By blocking BTK, tolebrutinib reduces the activation of these B cells.
In addition, BTK is involved in the activity of microglia and macrophages, which are other immune cells found in the brain and spinal cord and are known to contribute to chronic inflammation and damage in MS. By blocking BTK in these cells, tolebrutinib is expected to reduce inflammation and help slow disease progression.
Cenrifki was shown to be more effective than placebo (a dummy treatment) at delaying the progression of the disease in a main study involving 1,131 patients with secondary progressive MS who did not have relapses in the last two years.
Disease progression was defined as worsening of the disease which is not related to a relapse and lasted for at least 6 months; it was measured using a standard scale called the expanded disability status scale (EDSS). During the study, 26.9% of patients receiving treatment with Cenrifki experienced disease progression compared with 37.2% of patients taking placebo.
Studies carried out with Cenrifki are described in more detail in the medicine’s assessment report.
For the full list of side effects and restrictions with Cenrifki, see the package leaflet.
The most common side effects with Cenrifki (which may affect more than 1 in 10 people) include COVID-19 and upper respiratory tract (nose and throat) infections.
Some side effects can be serious. The most frequent serious side effect with this medicine is COVID-19 pneumonia (infection of the lungs) which may affect more than 1 in 10 people. Liver injury can occur with Cenrifki, especially during the first months of treatment, and regular blood tests are required to check liver function.
Cenrifki must not be used in patients with moderate to severe liver problems, certain abnormal liver blood test results, or a severely weakened immune system.
At the time of approval of Cenrifki, there were limited treatment options for patients with progressive MS. Cenrifki was shown to delay the progression of disability in secondary progressive MS. The main safety concern is liver injury, which can be managed through early detection and close monitoring of liver function.
The European Medicines Agency therefore decided that Cenrifki’s benefits are greater than its risks and it can be authorised for use in the EU.
The company that markets Cenrifki will provide educational material for doctors who are expected to prescribe this medicine. These will include information about the risk of liver problems with Cenrifki and the need to monitor liver function before and during treatment. A card will also be given to patients about the risk of liver injury, the need for liver monitoring and to contact their doctor if they develop symptoms of liver injury.
These materials may be made available by national competent authorities on their websites.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cenrifki have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Cenrifki are continuously monitored. Suspected side effects reported with Cenrifki are carefully evaluated and any necessary action taken to protect patients.
Cenrifki received a marketing authorisation valid throughout the EU on 19-06-2026.
Product information
19/06/2026
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
- Cenrifki
- Active substance
- tolebrutinib
- International non-proprietary name (INN) or common name
- tolebrutinib
- Therapeutic area (MeSH)
- Multiple Sclerosis, Chronic Progressive
- Anatomical therapeutic chemical (ATC) code
- L04AA62
Pharmacotherapeutic group
Selective immunosuppressantsTherapeutic indication
Cenrifki is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) without relapses in the last 2 years.
Assessment history
News on Cenrifki
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