Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Lixiana   
Auth. number : EU/1/15/993
Active substance : edoxaban
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AF - Direct factor Xa inhibitors
Chemical substance: B01AF03 - Edoxaban
(See WHO ATC Index)
Indication: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).
Marketing Authorisation Holder: Daiichi Sankyo Europe GmbH
Zielstattstraße 48, 81379 München, Deutschland
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 Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
23/06/2015 Centralised - Authorisation EMEA/H/C/2629 (2015)4308 of 19/06/2015
08/10/2015 Centralised - Variation EMEA/H/C/2629/IB/2
Updated with Decision(2016) 6717 of 14/10/2016
22/03/2016 Centralised - Notification EMEA/H/C/2629/N/7
Updated with Decision(2016) 6717 of 14/10/2016
16/06/2016 Centralised - Notification EMEA/H/C/2629/N/8
Updated with Decision(2016) 6717 of 14/10/2016
12/08/2016 Centralised - Variation EMEA/H/C/2629/IB/9/G
Updated with Decision(2016) 6717 of 14/10/2016
18/10/2016 Centralised - Yearly update (2016) 6717 of 14/10/2016
15/06/2017 Centralised - Variation EMEA/H/C/2629/II/12
17/07/2017 PSUSA - Modification EMEA/H/C/2629/PSUSA/10387/201610 (2017) 5099 of 13/07/2017