Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany
Lixiana 15 mg film-coated tablets.
Lixiana 30 mg film-coated tablets.
Lixiana 60 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. 15 mg film-coated tablet: Orange, round-shaped film-coated tablets (6.7 mm diameter) debossed with “DSC L15”. 30 mg film-coated tablet: Pink, round-shaped film-coated tablets (8.5 mm diameter) debossed with “DSC L30”. 60 mg film-coated tablet: Yellow, round-shaped film-coated tablets (10.5 mm diameter) debossed with “DSC L60”. |
Each 15 mg film-coated tablet contains 15 mg edoxaban (as tosilate).
Each 30 mg film-coated tablet contains 30 mg edoxaban (as tosilate).
Each 60 mg film-coated tablet contains 60 mg edoxaban (as tosilate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Edoxaban |
Edoxaban is a highly selective, direct and reversible inhibitor of factor Xa, the serine protease located in the final common pathway of the coagulation cascade. Edoxaban inhibits free factor Xa, and prothrombinase activity. Inhibition of factor Xa in the coagulation cascade reduces thrombin generation, prolongs clotting time and reduces the risk of thrombus formation. |
| List of Excipients |
|---|
|
Tablet core: Mannitol (E421) Film-coat: Hypromellose (E464) |
15 mg film-coated tablets: PVC/Aluminium blisters. Cartons of 10 film-coated tablets. PVC/Aluminium perforated unit dose blisters of 10 × 1 film-coated tablets.
30 mg and 60 mg film-coated tablets: PVC/Aluminium blisters. Cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98, 100 film-coated tablets. PVC/Aluminium perforated unit dose blisters of 10 × 1, 50 × 1 and 100 × 1 film-coated tablets.
Not all pack sizes may be marketed.
Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany
15 mg film-coated tablets: EU/1/15/993/001, EU/1/15/993/016
30 mg film-coated tablets: EU/1/15/993/002, EU/1/15/993/004-015
60 mg film-coated tablets: EU/1/15/993/003, EU/1/15/993/017-028
Date of first authorisation: 19 June 2015
| Drug | Countries | |
|---|---|---|
| LIXIANA | Austria, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Turkey, United Kingdom |
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