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 11/04/2019

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
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Publication details
Marketing-authorisation holder
Celgene Europe B.V. 
Revision
18
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

02/04/2019 Vidaza - EMEA/H/C/000978 - PSUSA/00000274/201805

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.
  • AML with >30% marrow blasts according to the WHO classification.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating
Average
1 rating
1 rating
2 ratings
1 rating