Defitelio (defibrotide)
Exceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- defibrotide
- Company
- Gentium S.r.l.
- Status
- Authorised
- Therapeutic area
- Hepatic Veno-Occlusive Disease
- CHMP opinion
- Thu 25 Jul 2013
- EU approval
- Fri 18 Oct 2013
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/002393
- ATC
- B01AX01
- Official record
- www.ema.europa.eu
Indication
Defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstructive syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy. It is indicated in adults and in adolescents, children and infants over 1 month of age.
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.