Basic Information
Eltrombopag Accord
Regulatory Information
EMEA/H/C/006459
March 28, 2025
January 30, 2025
2
May 20, 2025
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication 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.
Overview Summary
Eltrombopag Accord is a medicine 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 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 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. For more information on generic medicines, see the question-and-answer document [here](https://www.ema.europa.eu/en/documents/other/questions-and-answers-generic-medicines_en.pdf).