Azacitidine Celgene

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Withdrawn

This medicine's authorisation has been withdrawn

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Public Assessment Report (EPAR) for Azacitidine Celgene is updated to indicate that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: WITHDRAWAL
21/05/2021
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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).

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slovenščina (SL) (652.52 KB - PDF)

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Suomi (FI) (633.48 KB - PDF)

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svenska (SV) (638.06 KB - PDF)

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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

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