Coagadex (human coagulation factor X)
OrphanAccelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- human coagulation factor X
- Company
- Kedrion S.p.A.
- Status
- Authorised
- Therapeutic area
- Factor X Deficiency
- CHMP opinion
- Thu 28 Jan 2016
- EU approval
- Wed 16 Mar 2016
- Designations
- Orphan, Accelerated assessment
- Application
- EMEA/H/C/003855
- ATC
- B02BD13
- Official record
- www.ema.europa.eu
Indication
Coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency. Coagadex is indicated in all age groups.
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.