EMA — authorised 12 December 2024
- Application: EMEA/H/C/006417
- Marketing authorisation holder: Viatris Limited
- Local brand name: Eltrombopag Viatris
- 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
- Status: approved
The European Medicines Agency (EMA) approved Revolade (Eltrombopag Viatris) for marketing in the European Union on 12 December 2024. This approval is for the treatment of adult patients with primary immune thrombocytopenia (ITP) who have not responded to other treatments, as well as for paediatric patients aged 1 year and above with ITP lasting 6 months or longer. Additionally, Revolade is indicated for adult patients with chronic hepatitis C virus (HCV) infection who have thrombocytopenia that prevents or limits interferon-based therapy.