Dacogen
decitabine
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Dacogen. 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 Dacogen.
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List item
Dacogen : EPAR - Summary for the public (PDF/77.21 KB)
Adopted
First published: 16/10/2012
Last updated: 29/07/2016
EMA/499966/2012 -
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List item
Dacogen : EPAR - Risk-management-plan summary (PDF/29.78 KB)
First published: 20/02/2019
Authorisation details
Product details | |
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Name |
Dacogen
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Agency product number |
EMEA/H/C/002221
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Active substance |
Decitabine
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International non-proprietary name (INN) or common name |
decitabine
|
Therapeutic area (MeSH) |
Leukemia, Myeloid
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Anatomical therapeutic chemical (ATC) code |
L01BC08
|
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 | |
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Marketing-authorisation holder |
Janssen-Cilag International N.V.
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Revision |
13
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Date of issue of marketing authorisation valid throughout the European Union |
20/09/2012
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Contact address |
Product information
28/03/2019 Dacogen - EMEA/H/C/002221 - II/0039
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy.