Doptelet (avatrombopag)
- Region
- 🇪🇺 EU
- Active substance
- avatrombopag
- Company
- Swedish Orphan Biovitrum AB (publ)
- Status
- Authorised
- Therapeutic area
- Thrombocytopenia
- CHMP opinion
- Fri 26 Apr 2019
- EU approval
- Thu 20 Jun 2019
- Application
- EMEA/H/C/004722
- ATC
- B02BX
- Official record
- www.ema.europa.eu
Indication
Doptelet is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure. Doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
Regulatory milestones
No milestones recorded in the last year.
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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.