Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Bayer AG, 51368 Leverkusen, Germany
Xarelto 1 mg/mL granules for oral suspension.
Pharmaceutical Form |
---|
Granules for oral suspension. White granules. |
The granules contain 19.7 mg rivaroxaban per gram.
Each bottle contains 51.7 mg rivaroxaban or 103.4 mg rivaroxaban.
Following reconstitution the oral suspension contains 1 mg rivaroxaban per mL.
Excipient with known effect: Each mL of the reconstituted oral suspension contains 1.8 mg sodium benzoate (E211), 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 |
---|
Citric acid, anhydrous (E330) |
Xarelto 1 mg/mL granules for oral suspension is packed in a folding box containing:
For children weighing less than 4 kg:
or
For children weighing 4 kg and more:
Not all pack sizes may be marketed.
Bayer AG, 51368 Leverkusen, Germany
EU/1/08/472/050-051
Date of first authorisation: 30 September 2008
Date of latest renewal: 22 May 2018
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.