Vidaza
azacitidine
Table of contents
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.
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Vidaza : EPAR - Summary for the public (PDF/83.5 KB)
First published: 23/01/2009
Last updated: 17/08/2016 -
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Vidaza : EPAR - Risk-management-plan (PDF/1.13 MB)
First published: 15/06/2023
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 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 | |
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Marketing-authorisation holder |
Bristol-Myers Squibb Pharma EEIG
|
Revision |
26
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Date of issue of marketing authorisation valid throughout the European Union |
17/12/2008
|
Contact address |
Plaza 254 |
Product information
28/04/2022 Vidaza - EMEA/H/C/000978 - II/0057
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).
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
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 Organisation (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.