Eltrombopag Viatris
Authorised
This medicine is authorised for use in the European Union
eltrombopag
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Eltrombopag Viatris is a medicine that is used for the treatment of:
- primary immune thrombocytopenia (ITP), a disease in which the patient’s immune system destroys platelets (components in the blood that help it to clot). Patients with ITP have low platelet counts in the blood (thrombocytopenia) and are at risk of bleeding. Eltrombopag Viatris is used in patients from 1 year of age for whom treatment with medicines such as corticosteroids or immunoglobulins has not worked. In children and adolescents, the medicine is used when they have had the disease for at least 6 months;
- thrombocytopenia in adults with chronic (long-term) hepatitis C, a liver disease caused by the hepatitis C virus. Eltrombopag Viatris is used when the thrombocytopenia is too severe to allow interferon-based therapy (a type of treatment for hepatitis C).
Eltrombopag Viatris contains the active substance eltrombopag and is a ‘generic medicine’. This means that Eltrombopag 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 Eltrombopag Viatris is Revolade. For more information on generic medicines, see the question-and-answer document here.
Eltrombopag Viatris is available as tablets to be taken by mouth. The medicine can only be obtained with a prescription, and treatment should be started and supervised by a doctor experienced in treating blood diseases or chronic hepatitis C and its complications.
The dose depends on the patient’s age and the disease for which Eltrombopag Viatris is being used; it is adjusted as needed to maintain an appropriate platelet level.
For more information about using Eltrombopag Viatris, see the package leaflet or contact your doctor or pharmacist.
In the body, a hormone called ‘thrombopoietin’ stimulates the production of platelets by attaching to certain receptors (targets) in the bone marrow. The active substance in Eltrombopag Viatris, eltrombopag, also attaches to and stimulates the thrombopoietin receptors. This increases the production of platelets, improving platelet counts.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Revolade, and do not need to be repeated for Eltrombopag Viatris.
As for every medicine, the company provided studies on the quality of Eltrombopag Viatris. The company also carried out a study that showed that it 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.
Because Eltrombopag 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, Eltrombopag Viatris has been shown to have comparable quality and to be bioequivalent to Revolade. Therefore, the Agency’s view was that, as for Revolade, the benefits of Eltrombopag 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 Eltrombopag Viatris have been included in the summary of product characteristics and the package leaflet. Any additional measures in place for Revolade also apply to Eltrombopag Viatris where appropriate.
As for all medicines, data on the use of Eltrombopag Viatris are continuously monitored. Suspected side effects reported with Eltrombopag Viatris are carefully evaluated and any necessary action taken to protect patients.
Eltrombopag Viatris received a marketing authorisation valid throughout the EU on 12 December 2024.
Product information
Latest procedure affecting product information:
VR/0000248123
26/02/2025
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).
Product details
- Name of medicine
- Eltrombopag Viatris
- Active substance
- eltrombopag olamine
- International non-proprietary name (INN) or common name
- eltrombopag
- Therapeutic area (MeSH)
- Purpura, Thrombocytopenic, Idiopathic
- Anemia, Aplastic
- Anatomical therapeutic chemical (ATC) code
- B02BX05
Pharmacotherapeutic group
AntihemorrhagicsTherapeutic indication
Eltrombopag Viatris is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
Eltrombopag Viatris is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).
Eltrombopag Viatris is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4.2 and 5.1).
News on Eltrombopag Viatris
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