Vidaza

RSS

azacitidine

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

Overview

This is a summary of the European public assessment report (EPAR) for Vidaza. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Vidaza.

This EPAR was last updated on 30/10/2018

Authorisation details

Product details
Name
Vidaza
Agency product number
EMEA/H/C/000978
Active substance
azacitidine
International non-proprietary name (INN) or common name
azacitidine
Therapeutic area (MeSH)
Myelodysplastic Syndromes
Anatomical therapeutic chemical (ATC) code
L01BC07
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Celgene Europe B.V. 
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
17/12/2008
Contact address

Celgene Europe B.V.
Winthontlaan 6 N
3526KV Utrecht
The Netherlands

Product information

30/07/2018 Vidaza - EMEA/H/C/000978 - T/0042

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Vidaza 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 Organization (WHO) classification.

Vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for HSCT with AML with >30% marrow blasts according to the WHO classification.

Assessment history

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