Human medicines European public assessment report (EPAR): Eltrombopag Accord, eltrombopag, Date of authorisation: 28/03/2025, Revision: 6, Status: Authorised

Full Article Content

Eltrombopag Accord is a medicine used for the treatment of: Eltrombopag Accord contains the active substance eltrombopag and is a ‘generic medicine’. This means that Eltrombopag Accord 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 Accord is Revolade. Application under evaluation European Commission decision 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 Accord 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 Accord is used when the thrombocytopenia is too severe to allow interferon-based therapy (a type of treatment for hepatitis C). Eltrombopag Accord is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e. g. corticosteroids, immunoglobulins). Eltrombopag Accord 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). Eltrombopag Accord 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. Product information – with tracked changes The approved product information for this medicine is available below showing the changes since the previous procedure affecting the product information. The same document without tracked changes is above under '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: English (EN) (1.89 MB – PDF) English (EN) (161.45 KB – PDF) summary of product characteristics (annex I);

manufacturing authorisation holder responsible for batch release (annex IIA); conditions of the marketing authorisation (annex IIB);

package leaflet (annex IIIB). English (EN) (87.03 KB – PDF) This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona SPAIN English (EN) (297.93 KB – DOCX) Eltrombopag Accord: EPAR – Medicine overview Eltrombopag Accord: EPAR – Risk management plan Eltrombopag Accord: EPAR – Product information Eltrombopag Accord: EPAR – All authorised presentations Eltrombopag Accord 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 who has experience 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 Accord is being used;

it is adjusted as needed to maintain an appropriate platelet level. For more information about using Eltrombopag Accord, 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 Accord, 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 Accord. As for every medicine, the company provided studies on the quality of Eltrombopag Accord. 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 Accord 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.