Idelvion (albutrepenonacog alfa)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- albutrepenonacog alfa
- Company
- CSL Behring GmbH
- Status
- Authorised
- Therapeutic area
- Hemophilia B
- CHMP opinion
- Thu 25 Feb 2016
- EU approval
- Wed 11 May 2016
- Designations
- Orphan
- Application
- EMEA/H/C/003955
- ATC
- B02BD04
- Official record
- www.ema.europa.eu
Indication
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
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.