Lixiana (edoxaban)
- Region
- 🇪🇺 EU
- Active substance
- edoxaban
- Company
- Daiichi Sankyo Europe GmbH
- Status
- Authorised
- Therapeutic area
- Stroke; Venous Thromboembolism
- CHMP opinion
- Thu 23 Apr 2015
- EU approval
- Fri 19 Jun 2015
- Application
- EMEA/H/C/002629
- ATC
- B01
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Roteas Authorised · Berlin-Chemie AG
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.