Hemgenix (etranacogene dezaparvovec)
OrphanPRIMEATMPConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- etranacogene dezaparvovec
- Company
- CSL Behring GmbH
- Status
- Authorised
- Therapeutic area
- Hemophilia B
- CHMP opinion
- Thu 15 Dec 2022
- EU approval
- Mon 20 Feb 2023
- Designations
- Orphan, PRIME, ATMP, Conditional, Additional monitoring
- Application
- EMEA/H/C/004827
- ATC
- B02BD
- Official record
- www.ema.europa.eu
Indication
Treatment of severe and moderately severe Haemophilia B (congenital Factor IX deficiency) in adult patients without a history of Factor IX inhibitors.
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.