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 30/08/2017

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
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
Marketing-authorisation holder
Janssen-Cilag International N V  
Revision
10
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

24/08/2017 Dacogen - EMEA/H/C/002221 - II/0031

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

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