Azacitidine Adienne (azacitidine)
Generic
- Region
- 🇪🇺 EU
- Active substance
- azacitidine
- Company
- Adienne S.r.l. S.U.
- Status
- Application withdrawn
- Therapeutic area
- Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Acute
- Designations
- Generic
- Application
- EMEA/H/C/006695
- ATC
- L01BC07
- Official record
- www.ema.europa.eu
Indication
Treatment of myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML).
Regulatory milestones
Mon 13 Jul 2026🇪🇺 Application withdrawn (EU)
Azacitidine Adienne (azacitidine): EU application withdrawn
Same substance in other markets
- 🇪🇺 Onureg Authorised · Bristol-Myers Squibb Pharma EEIG
- 🇪🇺 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- 🇪🇺 Azacitidine Celgene Withdrawn · Celgene Europe BV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.