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EMA Product

Onureg

Product approved by European Medicines Agency (EU)

Basic Information

Onureg

Regulatory Information

EMEA/H/C/004761

Authorised

June 17, 2021

April 22, 2021

2

February 18, 2025

Company Information

Ireland

Plaza 254 Blanchardstown Corporate Park 2 Dublin 15 D15 T867

Bristol-Myers Squibb Pharma EEIG

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT).

Overview Summary

Onureg is a cancer medicine used to treat acute myeloid leukaemia (AML), a cancer of white blood cells. It is used for maintenance treatment after the initial cancer treatment has brought the disease under control, in patients who cannot be given haematopoietic stem cell transplantation (a procedure to replace the cells that produce blood cells) to prevent the cancer coming back. Onureg contains the active substance azacitidine.

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