Zemcelpro (allogeneic umbilical cord-derived CD34- cells, non-expanded;dorocubicel)
OrphanPRIMEATMPConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- allogeneic umbilical cord-derived CD34- cells, non-expanded;dorocubicel
- Company
- Cordex Biologics International Limited
- Status
- Authorised
- Therapeutic area
- Hematologic Neoplasms; Hematopoietic Stem Cell Transplantation
- CHMP opinion
- Thu 19 Jun 2025
- EU approval
- Mon 25 Aug 2025
- Designations
- Orphan, PRIME, ATMP, Conditional, Additional monitoring
- Application
- EMEA/H/C/005772
- ATC
- B05AX04
- Official record
- www.ema.europa.eu
Indication
Treatment of adult patients with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available
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.