Azacitidine Celgene

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azacitidine

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Medicine has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 04/08/2021

Authorisation details

Product details
Name
Azacitidine Celgene
Agency product number
EMEA/H/C/005300
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
Publication details
Marketing-authorisation holder
Celgene Europe BV
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
02/08/2019
Contact address

Winthontlaan 6 N
3526KV Utrecht
The Netherlands

Product information

21/05/2021 Azacitidine Celgene - EMEA/H/C/005300 - WITHDRAWAL

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

Assessment history

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