Xigris (drotrecogin alfa (activated))
Exceptional circumstances
- Region
- 🇪🇺 EU
- Active substance
- drotrecogin alfa (activated)
- Company
- Eli Lilly Nederland B.V.
- Status
- Withdrawn
- Therapeutic area
- Sepsis; Multiple Organ Failure
- EU approval
- Thu 22 Aug 2002
- Designations
- Exceptional circumstances
- Application
- EMEA/H/C/000396
- ATC
- B01AD10
- Official record
- www.ema.europa.eu
Indication
Xigris is indicated for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care. The use of Xigris should be considered mainly in situations when therapy can be started within 24 hours after the onset of organ failure (for further information see section 5.1).
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.