Zemcelpro
What Zemcelpro is used for
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
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
- Advanced therapy: a gene, cell or tissue-engineered medicine.
- PRIME: a priority medicine that the EMA supported early because it may meet an unmet need.
- Conditional approval: approved on less complete data because the need is high; more data must follow.
Key facts
- Brand
- Zemcelpro
- Active substance
- allogeneic umbilical cord-derived CD34- cells, non-expanded;dorocubicel
- Disease area
- Hematologic Neoplasms; Hematopoietic Stem Cell Transplantation
- Medicine group
- Other blood products
- ATC code
- B05AX04
- Marketing authorisation holder
- Cordex Biologics International Limited
- Authorised in the EU since
- 2025
Official information
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Zemcelpro used for?
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
What is the active substance in Zemcelpro?
Zemcelpro contains allogeneic umbilical cord-derived CD34- cells, non-expanded;dorocubicel.
Who makes Zemcelpro?
The EU marketing authorisation holder is Cordex Biologics International Limited.
Is Zemcelpro an orphan medicine?
Yes. Zemcelpro is designated an orphan medicine in the EU, for a rare disease (Hematologic Neoplasms; Hematopoietic Stem Cell Transplantation).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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