Onureg (azacitidine)
- Region
- 🇪🇺 EU
- Active substance
- azacitidine
- Company
- Bristol-Myers Squibb Pharma EEIG
- Status
- Authorised
- Therapeutic area
- Leukemia, Myeloid, Acute
- CHMP opinion
- Thu 22 Apr 2021
- EU approval
- Thu 17 Jun 2021
- Application
- EMEA/H/C/004761
- ATC
- L01BC07
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Azacitidine Adienne Application withdrawn · Adienne S.r.l. S.U.
- 🇪🇺 Azacitidine Mylan Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Azacitidine Kabi Authorised · Fresenius Kabi Deutschland GmbH
- 🇪🇺 Azacitidine Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Vidaza Authorised · Bristol-Myers Squibb Pharma EEIG
- 🇪🇺 Azacitidine betapharm Authorised · betapharm Arzneimittel GmbH
- 🇪🇺 Azacitidine Celgene Withdrawn · Celgene Europe BV
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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.