Xiapex (collagenase Clostridium histolyticum)
- Region
- 🇪🇺 EU
- Active substance
- collagenase Clostridium histolyticum
- Company
- Swedish Orphan Biovitrum AB
- Status
- Withdrawn
- Therapeutic area
- Dupuytren Contracture
- EU approval
- Mon 28 Feb 2011
- Application
- EMEA/H/C/002048
- ATC
- M09AB02
- Official record
- www.ema.europa.eu
Indication
The treatment of Dupuytren’s contracture in adult patients with a palpable cord. The treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
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.