Ruxolitinib Viatris
Authorised
This medicine is authorised for use in the European Union
ruxolitinib hemifumarate
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Introduction
Ruxolitinib Viatris is a medicine used to treat the following conditions:
- splenomegaly (enlarged spleen) or other disease-related symptoms such as fever, night sweats, bone pain and weight loss in adults who have myelofibrosis. Myelofibrosis is a disease in which the bone marrow becomes very dense and rigid and produces abnormal, immature blood cells;
- polycythaemia vera in adults in whom the medicine hydroxycarbamide (also known as hydroxyurea) does not work or causes unacceptable side effects. In polycythaemia vera, too many red blood cells are produced, which can cause reduced blood flow to the organs due to ‘thickening’ of the blood and occasionally the formation of blood clots;
- acute graft-versus-host disease (GvHD, when donor cells attack the body shortly after a transplant) in adults and children aged 28 days and older for whom corticosteroids or other systemic therapies (treatments given by mouth or injection) did not work well enough;
- chronic graft-versus-host-disease (which usually develops later than acute GvHD, within several weeks to months after a transplant) in adults and children aged 6 months and older for whom corticosteroids or other systemic therapies did not work well enough.
Ruxolitinib Viatris contains the active substance ruxolitinib and is a ‘generic medicine’. This means that Ruxolitinib Viatris contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Ruxolitinib Viatris is Jakavi. For more information on generic medicines, see the question-and-answer document here.
Ruxolitinib Viatris can only be obtained with a prescription and treatment should only be started by a doctor who is experienced with the use of cancer medicines.
Ruxolitinib Viatris is available as tablets to be taken by mouth twice daily. The recommended dose depends on the condition it is used for.
Ruxolitinib Viatris tablets are not suitable for patients who cannot swallow tablets whole and children less than 6 years old. Other medicines containing ruxolitinib are available for these patients.
The doctor should reduce the dose, or stop treatment if certain side effects occur.
For more information about using Ruxolitinib Viatris, see the package leaflet or contact your doctor or pharmacist.
The active substance in Ruxolitinib Viatris, ruxolitinib, works by blocking a group of enzymes known as Janus kinases (JAKs), which are involved in the production and growth of blood cells.
In myelofibrosis and polycythaemia vera, there is too much JAK activity, leading to the abnormal production of blood cells. These blood cells can build-up in organs, including the spleen, causing them to become enlarged.
JAKs are also involved in the development and activation of cells of the immune system (the body’s natural defences) that play a role in GvHD. By blocking JAKs, ruxolitinib helps to reduce inflammation, thereby reducing the symptoms of acute and chronic GvHD.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Jakavi, and do not need to be repeated for Ruxolitinib Viatris.
As for every medicine, the company provided studies on the quality of Ruxolitinib Viatris. The company also carried out studies that showed that Ruxolitinib Viatris is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Studies carried out with Ruxolitinib Viatris are described in more detail in the medicine’s assessment report.
Because Ruxolitinib Viatris is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
The European Medicines Agency concluded that, in accordance with EU requirements, Ruxolitinib Viatris has been shown to have comparable quality and to be bioequivalent to Jakavi. Therefore, the Agency’s view was that, as for Jakavi, the benefits of Ruxolitinib Viatris outweigh the identified 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 Ruxolitinib Viatris have been included in the summary of product characteristics and the package leaflet. Any additional measures in place for Jakavi also apply to Ruxolitinib Viatris where appropriate.
As for all medicines, data on the use of Ruxolitinib Viatris are continuously monitored. Suspected side effects reported with Ruxolitinib Viatris are carefully evaluated and any necessary action taken to protect patients.
Ruxolitinib Viatris received a marketing authorisation valid throughout the EU on 18 September 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
- Ruxolitinib Viatris
- Active substance
- ruxolitinib hemifumarate
- International non-proprietary name (INN) or common name
- ruxolitinib hemifumarate
- Therapeutic area (MeSH)
- Primary Myelofibrosis
- Polycythemia Vera
- Graft vs Host Disease
- Anatomical therapeutic chemical (ATC) code
- L01EJ01
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Myelofibrosis (MF)
Ruxolitinib Viatris is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.
Polycythaemia vera (PV)
Ruxolitinib Viatris is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.
Graft versus host disease (GvHD)
Acute GvHD
Ruxolitinib Viatris is indicated for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).
Chronic GvHD
Ruxolitinib Viatris is indicated for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).
Assessment history
News on Ruxolitinib Viatris
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