Revolade (eltrombopag)
- Region
- 🇪🇺 EU
- Active substance
- eltrombopag
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Purpura, Thrombocytopenic, Idiopathic; Anemia, Aplastic
- CHMP opinion
- Thu 17 Dec 2009
- EU approval
- Thu 11 Mar 2010
- Application
- EMEA/H/C/001110
- ATC
- B02BX05
- Official record
- www.ema.europa.eu
Indication
Revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1). Revolade 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). Revolade 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 4.4 and 5.1). Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Eltrombopag Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Eltrombopag Viatris Authorised · Viatris Limited
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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.