Eltrombopag Viatris (eltrombopag)
- Region
- 🇪🇺 EU
- Active substance
- eltrombopag
- Company
- Viatris Limited
- Status
- Authorised
- Therapeutic area
- Purpura, Thrombocytopenic, Idiopathic
- CHMP opinion
- Thu 17 Oct 2024
- EU approval
- Thu 12 Dec 2024
- Designations
- Generic, Additional monitoring
- Application
- EMEA/H/C/006417
- ATC
- B02BX05
- Official record
- www.ema.europa.eu
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 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 4.2 and 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Eltrombopag Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Revolade Authorised · Novartis Europharm 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.