EMA — authorised 25 August 2025
- Application: EMEA/H/C/005772
- Marketing authorisation holder: Cordex Biologics International Limited
- Local brand name: Zemcelpro
- 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
- Pathway: conditional, orphan, ATMP, PRIME
- Status: approved
On 25 August 2025, the European Medicines Agency (EMA) granted marketing authorisation for DOROCUBICEL (Zemcelpro), a medicinal product developed by Cordex Biologics International Limited. DOROCUBICEL is indicated for the treatment of adult patients with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning. This treatment is for patients who have no other suitable donor cells available.