Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Bayer AG, 51368 Leverkusen, Germany
Xarelto 15 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet (tablet). Red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and “15” and a triangle on the other side. |
Each film-coated tablet contains 15 mg rivaroxaban.
Excipient with known effect: Each film-coated tablet contains 24.13 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) |
Cartons containing 10, 14, 28, 42 or 98 film-coated tablets in PP/Alu foil blisters.
Cartons containing 10 × 1 or 100 × 1 film-coated tablets in PP/Alu foil perforated unit dose blisters.
Multipacks containing 10 packs of 10 × 1 (100 film-coated tablets) in PP/Alu foil perforated unit dose blisters.
Cartons containing 14 film-coated tablets in PVC/PVDC/Alu foil blisters.
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/1/08/472/011-016
EU/1/08/472/023
EU/1/08/472/036
EU/1/08/472/038
EU/1/08/472/048
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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