Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Dacogen   
Auth. number : EU/1/12/792
Active substance : Decitabine
Orphan market exclusivity for "Treatment of acute myeloid leukaemia" (based on designation EU/3/06/370) started on 24/09/2012
   10 years of market exclusivity
   This orphan market exclusivity will expire on 24/09/2022
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01B - Antimetabolites
Chemical subgroup: L01BC - Pyrimidine analogues
Chemical substance: L01BC08 - decitabine
(See WHO ATC Index)
Indication: Dacogen is indicated for the treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
24/09/2012 Centralised - Authorisation EMEA/H/C/2221 (2012)6705 of 20/09/2012
11/01/2013 Centralised - Notification EMEA/H/C/2221/N/2
Updated with Decision(2014)315 of 16/01/2014
27/09/2013 Centralised - Variation EMEA/H/C/2221/IAIN/6
Updated with Decision(2014)315 of 16/01/2014
21/01/2014 PSUSA - Modification EMEA/H/C/2221/PSUV/8 (2014)315 of 16/01/2014
23/07/2014 PSUSA - Modification EMEA/H/C/2221/PSUV/11 (2014)5260 of 18/07/2014
27/03/2015 Centralised - Variation EMEA/H/C/2221/IB/19
Updated with Decision(2016)1521 of 07/03/2016
9/03/2016 Centralised - Yearly update (2016)1521 of 7/03/2016
4/07/2016 Centralised - 2-Monthly update EMEA/H/C/2221/IB/26 (2016)4241 of 30/06/2016
27/10/2016 Centralised - Variation EMEA/H/C/2221/II/28/G
Updated with Decision(2017)1404 of 23/02/2017
27/02/2017 PSUSA - Modification EMEA/H/C/PSUSA/9118/201605 (2017)1404 of 23/02/2017
24/05/2017 Centralised - Renewal EMEA/H/C/2221/R/30 (2017)3646 of 22/05/2017
28/08/2017 Centralised - 2-Monthly update EMEA/H/C/2221/II/31 (2017)5941 of 24/08/2017
12/10/2018 Centralised - Notification EMEA/H/C/2221/N/38
Updated with Decision(2019)1080 of 07/02/2019
15/11/2018 Centralised - Variation EMEA/H/C/2221/II/35
Updated with Decision(2019)1080 of 07/02/2019
25/01/2019 Centralised - 2-Monthly update EMEA/H/C/002221/II/0033 (2019)678 of 23/01/2019
11/02/2019 PSUSA - Modification EMEA/H/C/PSUSA/00009118/201805 (2019)1080 of 7/02/2019
28/03/2019 Centralised - Variation EMEA/H/C/002221/II/0039