Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Bayer AG, 51368 Leverkusen, Germany
Xarelto 15 mg film-coated tablets.
Xarelto 20 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). 15 mg film-coated 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. 20 mg film-coated tablet: brown-red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and “20” and a triangle on the other side. |
Each 15 mg film-coated tablet contains 15 mg rivaroxaban.
Each 20 mg film-coated tablet contains 20 mg rivaroxaban.
Excipient with known effect:
Each 15 mg film-coated tablet contains 24.13 mg lactose (as monohydrate), see section 4.4.
Each 20 mg film-coated tablet contains 21.76 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 |
|---|
|
Tablet core: Microcrystalline cellulose Film-coat: Macrogol 3350 |
Treatment initiation pack for the first 4 weeks of treatment:
PP/Aluminium foil blisters in a wallet containing 49 film-coated tablets: 42 film-coated tablets Xarelto 15 mg and 7 film-coated tablets Xarelto 20 mg.
Bayer AG, 51368 Leverkusen, Germany
EU/1/08/472/040
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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