Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Berlin-Chemie AG, Glienicker Weg 125, 12489 Berlin, Germany
Roteas 15 mg film-coated tablets.
Roteas 30 mg film-coated tablets.
Roteas 60 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Roteas 15 mg film-coated tablets: Orange, round-shaped film-coated tablets (6.7 mm diameter) debossed with “DSC L15”. Roteas 30 mg film-coated tablets: Pink, round-shaped film-coated tablets (8.5 mm diameter) debossed with “DSC L30”. Roteas 60 mg film-coated tablets: Yellow, round-shaped film-coated tablets (10.5 mm diameter) debossed with “DSC L60”. |
Roteas 15 mg film-coated tablets: Each 15 mg film-coated tablet contains 15 mg edoxaban (as tosilate).
Roteas 30 mg film-coated tablets: Each 30 mg film-coated tablet contains 30 mg edoxaban (as tosilate).
Roteas 60 mg film-coated tablets: 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) Roteas 15 mg film-coated tablets: Iron oxide yellow (E172) Roteas 30 mg film-coated tablets: Iron oxide red (E172) Roteas 60 mg film-coated tablets: Iron oxide yellow (E172) |
Roteas 15 mg film-coated tablets:
PVC/Aluminium blisters in cartons of 10 film-coated tablets.
PVC/Aluminium perforated unit dose blisters in cartons of 10 × 1 film-coated tablets.
Roteas 30 mg film-coated tablets:
PVC/Aluminium blisters in cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98, 100 film-coated tablets.
PVC/Aluminium perforated unit dose blisters in cartons of 10 × 1, 50 × 1 and 100 × 1 film-coated tablets.
HDPE bottles with a PP screw cap containing 90 film-coated tablets.
Roteas 60 mg film-coated tablets:
PVC/Aluminium blisters in cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98, 100 film-coated tablets.
PVC/Aluminium perforated unit dose blisters in cartons of 10 × 1, 50 × 1 and 100 × 1 film-coated tablets.
HDPE bottles with a PP screw cap containing 90 film-coated tablets.
Not all pack sizes may be marketed.
Berlin-Chemie AG, Glienicker Weg 125, 12489 Berlin, Germany
Roteas 15 mg film-coated tablets: EU/1/16/1152/001-002
Roteas 30 mg film-coated tablets: EU/1/16/1152/003-015, EU/1/16/1152/029
Roteas 60 mg film-coated tablets: EU/1/16/1152/016-028, EU/1/16/1152/030
Date of first authorisation: 20 April 2017
| Drug | Countries | |
|---|---|---|
| ROTEAS | Austria, Brazil, Estonia, Croatia, Ireland, Lithuania, Poland, Romania |
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