- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 19 May 2021, the European Commission withdrew the marketing authorisation for Azacitidine Celgene (SRD) (azacitidine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Celgene Europe BV, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Azacitidine Celgene was granted marketing authorisation in the EU on 2 August 2019 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 10-29 % marrow blasts without myeloproliferative disorder,
- acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification,
- AML with >30% marrow blasts according to the WHO classification.
The marketing authorisation was initially valid for a 5-year period.
Azacitidine Celgene is identical to Vidaza, which is authorised in the EU for the same indications as Azacitidine Celgene. The marketing authorisation holder will maintain the marketing authorisation for Vidaza.
The European Public Assessment Report (EPAR) for Azacitidine Celgene is updated to indicate that the marketing authorisation is no longer valid.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Azacitidine Celgene
- Active substance
- azacitidine
- International non-proprietary name (INN) or common name
- azacitidine
- Therapeutic area (MeSH)
- Myelodysplastic Syndromes
- Leukemia, Myelomonocytic, Chronic
- Leukemia, Myeloid, Acute
- Anatomical therapeutic chemical (ATC) code
- L01BC07
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Azacitidine Celgene 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 29 % marrow blasts without myeloproliferative disorder,
- acute myeloid leukaemia (AML) with 20 30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification,
- AML with >30% marrow blasts according to the WHO classification.