Azacitidine Celgene

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azacitidine

Authorised
This medicine is authorised for use in the European Union.

Overview

Azacitidine Celgene is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient receives stem cells to restore the bone marrow’s ability to produce healthy blood cells):

  • myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow. In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a cancer affecting white blood cells called myeloid cells). Azacitidine Celgene is used in patients with an intermediate to high risk of progressing to AML or death;
  • chronic myelomonocytic leukaemia (CMML, a cancer affecting white blood cells called monocytes). Azacitidine Celgene is used when the bone marrow consists of 10 to 29% abnormal cells and the bone marrow is not producing large numbers of white blood cells;
  • AML that has developed from a myelodysplastic syndrome and the bone marrow consists of 20 to 30% abnormal cells;
  • AML, when the bone marrow has more than 30% abnormal cells.

Azacitidine Celgene contains the active substance azacitidine.

This medicine is the same as Vidaza, which is already authorised in the EU. The company that makes Vidaza has agreed that its scientific data can be used for Azacitidine Celgene (‘informed consent’).

This EPAR was last updated on 14/08/2019

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
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

02/08/2019 Azacitidine Celgene - EMEA/H/C/005300 -

Contents

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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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