Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
U.S. Food and Drug Administration
FDA Purple Book, September 2026 release; acquired 2026-10-10T15:29:54.330165+00:00; exact source fields retained with source-key projections.
Licence: FDA-created structured factual administrative metadata; public-domain policy with third-party exceptions · Added 11 Oct 2026
Report an error or request removalCorrections from the holder or the register are welcome.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Active substances
- Allogeneic regulatory t cell immunotherapy with hspc, T cells
- Strength
- >=1.0 10^6HSPC CELLS,0.9-3.510^6 TREG CELLS,0.9-6.910^6 TCON CELLS /PATIENT KG
- Dosage form
- Solution
- Route
- Intravenous
- Register
- United States (FDA)
- Status
- Marketed
- Status in the register
- Licensed / Rx
- Authorised
- 30 Jun 2026