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Pharmaceuticals - Union Register
Union Register of medicinal products for human use |
AUTHORISED |
Product information |
Invented name: | Dacogen
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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 procedures |
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 |