Azacitidine Celgene

Withdrawn

This medicine's authorisation has been withdrawn

azacitidine

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Public Assessment Report (EPAR) for Azacitidine Celgene is updated to indicate that the marketing authorisation is no longer valid.

Azacitidine Celgene : EPAR - Medicine overview

Reference Number: EMA/384352/2019

Azacitidine Celgene : EPAR - Risk-management-plan summary

Product information

Azacitidine Celgene : EPAR - Product information

Azacitidine Celgene : EPAR - All authorised presentations

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 agents

Therapeutic 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.

Authorisation details

• EMA product number:
  EMEA/H/C/005300
• Marketing authorisation holder:
  Celgene Europe BV

  Winthontlaan 6 N; 3526KV Utrecht; The Netherlands

• Opinion adopted:
  27/06/2019
• Marketing authorisation issued:
  02/08/2019
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Azacitidine Celgene : EPAR - Procedural steps taken and scientific information after the authorisation

Initial marketing authorisation documents

Azacitidine Celgene : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/445484/2019

CHMP summary of positive opinion for Azacitidine Celgene

Adopted Reference Number: EMA/CHMP/332005/2019