Azacitidine Celgene
azacitidine
Table of contents
Overview
The marketing authorisation for Medicine has been withdrawn at the request of the marketing-authorisation holder.
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Azacitidine Celgene : EPAR - Medicine overview (PDF/664.65 KB)
First published: 14/08/2019
Last updated: 04/08/2021
EMA/384352/2019 -
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Azacitidine Celgene : EPAR - Risk-management-plan summary (PDF/709.48 KB)
First published: 14/08/2019
Last updated: 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) |
|
| 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 |
Product information
21/05/2021 Azacitidine Celgene - EMEA/H/C/005300 - WITHDRAWAL
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
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.