Elzonris (tagraxofusp)
OrphanExceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- tagraxofusp
- Company
- Stemline Therapeutics B.V.
- Status
- Authorised
- Therapeutic area
- Lymphoma
- CHMP opinion
- Thu 12 Nov 2020
- EU approval
- Thu 07 Jan 2021
- Designations
- Orphan, Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/005031
- ATC
- L01XX67
- Official record
- www.ema.europa.eu
Indication
Elzonris is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
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.