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.
Dacogen : EPAR - Summary for the public (PDF/77.21 KB)Adopted
First published: 16/10/2012
Last updated: 29/07/2016
Dacogen : EPAR - Risk-management-plan summary (PDF/29.78 KB)
First published: 20/02/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Janssen-Cilag International N V
|Date of issue of marketing authorisation valid throughout the European Union||
07/02/2019 Dacogen - EMEA/H/C/002221 - PSUSA/00009118/201805
- 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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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.