Dacogen

RSS

decitabine

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 20/07/2021

Authorisation details

Product details
Name
Dacogen
Agency product number
EMEA/H/C/002221
Active substance
decitabine
International non-proprietary name (INN) or common name
decitabine
Therapeutic area (MeSH)
Leukemia, Myeloid
Anatomical therapeutic chemical (ATC) code
L01BC08
OrphanOrphan

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
Marketing-authorisation holder
Janssen-Cilag International N.V.  
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
20/09/2012
Contact address

Janssen-Cilag International N.V.
Turnhoutseweg 30
BE-2340 Beerse
Belgium

Product information

10/06/2021 Dacogen - EMEA/H/C/002221 - II/0044

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Product information documents contain:

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

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.

Assessment history

Changes since initial authorisation of medicine

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