Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Bayer AG, 51368 Leverkusen, Germany
Xarelto 10 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet (tablet). Light red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and “10” and a triangle on the other side. |
Each film-coated tablet contains 10 mg rivaroxaban.
Excipient with known effect: Each film-coated tablet contains 26.51 mg lactose (as monohydrate), see section 4.4.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Rivaroxaban |
Rivaroxaban is a highly selective direct factor Xa inhibitor with oral bioavailability. Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi. Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated. |
| List of Excipients |
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Tablet core: Microcrystalline cellulose Film-coat: Macrogol 3350 |
PP/Aluminium foil blisters in cartons of 5, 10, 14, 28, 30 or 98 film-coated tablets or perforated unit dose blisters in cartons of 10 × 1, 100 × 1, or in multipacks containing 100 (10 packs of 10 × 1) film-coated tablets.
PVC/PVDC/Aluminium foil blisters in cartons of 5, 10 or 30 film-coated tablets or perforated unit dose blisters in cartons of 10 × 1 or 100 × 1 film-coated tablets.
HDPE bottles with a PP screw cap containing 100 film-coated tablets.
Not all pack sizes may be marketed.
Bayer AG, 51368 Leverkusen, Germany
EU/1/08/472/001-010
EU/1/08/472/022
EU/1/08/472/042-045
Date of first authorisation: 30 September 2008
Date of latest renewal: 22 May 2018
| Drug | Countries | |
|---|---|---|
| XARELTO | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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