Azacitidine betapharm (azacitidine)
- Region
- 🇪🇺 EU
- Active substance
- azacitidine
- Company
- betapharm Arzneimittel GmbH
- Status
- Authorised
- Therapeutic area
- Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
- CHMP opinion
- Thu 30 Jan 2020
- EU approval
- Tue 24 Mar 2020
- Designations
- Generic
- Application
- EMEA/H/C/005075
- ATC
- L01BC07
- Official record
- www.ema.europa.eu
Indication
Azacitidine betapharm is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukaemia (CMML) with 10 % to 29 % marrow blasts without myeloproliferative disorder, acute myeloid leukaemia (AML) with 20 % to 30 % blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification, AML with > 30 % marrow blasts according to the WHO classification.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Onureg Authorised · Bristol-Myers Squibb Pharma EEIG
- 🇪🇺 Azacitidine Adienne Application withdrawn · Adienne S.r.l. S.U.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- 🇪🇺 Azacitidine Celgene Withdrawn · Celgene Europe BV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.