Eltrombopag Accord (eltrombopag)
- Region
- 🇪🇺 EU
- Active substance
- eltrombopag
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Purpura, Thrombocytopenic, Idiopathic
- CHMP opinion
- Thu 30 Jan 2025
- EU approval
- Fri 28 Mar 2025
- Designations
- Generic
- Application
- EMEA/H/C/006459
- ATC
- B02BX05
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Eltrombopag Viatris Authorised · Viatris Limited
- 🇪🇺 Revolade Authorised · Novartis Europharm Limited
Follow Eltrombopag Accord
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.