XARELTO Granules for oral suspension Ref.[114627] Active ingredients: Rivaroxaban

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Bayer AG, 51368 Leverkusen, Germany

Product name and form

Xarelto 1 mg/mL granules for oral suspension.

Pharmaceutical Form

Granules for oral suspension.

White granules.

Qualitative and quantitative composition

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)
Hypromellose (2910)
Mannitol (E421)
Microcrystalline cellulose and carmellose sodium
Sodium benzoate (E211)
Sucralose (E955)
Xanthan gum (E415)
Flavour sweet and creamy: flavouring substances, maltodextrin (maize), propylene glycol (E1520) and acacia gum (E414)

Pack sizes and marketing

Xarelto 1 mg/mL granules for oral suspension is packed in a folding box containing:

For children weighing less than 4 kg:

  • 2.625 g granules, corresponding to 51.7 mg rivaroxaban, in 1 brown glass bottle, for reconstitution in 50 mL water, closed with a child resistant screw cap
  • 2 blue syringes 1 mL with 0.1 mL marked graduations
  • 1 adapter for bottles and blue syringes
  • 1 water syringe 50 mL with 1 mL marked graduations

or

For children weighing 4 kg and more:

  • 5.25 g granules, corresponding to 103.4 mg rivaroxaban, in 1 brown glass bottle, for reconstitution in 100 mL water, closed with a child resistant screw cap
  • 2 blue syringes 5 mL with 0.2 mL marked graduations
  • 2 blue syringes 10 mL with 0.5 mL marked graduations
  • 1 adapter for bottles and blue syringes
  • 1 water syringe 100 mL with 2 mL marked graduations

Not all pack sizes may be marketed.

Marketing authorization holder

Bayer AG, 51368 Leverkusen, Germany

Marketing authorization dates and numbers

EU/1/08/472/050-051

Date of first authorisation: 30 September 2008
Date of latest renewal: 22 May 2018

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