XARELTO 15mg/20mg Film-coated tablet Ref.[7444] Active ingredients: Rivaroxaban

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Bayer AG, 51368 Leverkusen, Germany

Product name and form

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.

Qualitative and quantitative composition

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
Croscarmellose sodium
Lactose monohydrate
Hypromellose 2910
Sodium laurilsulphate
Magnesium stearate

Film-coat:

Macrogol 3350
Hypromellose 2910
Titanium dioxide (E171)
Iron oxide red (E172)

Pack sizes and marketing

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.

Marketing authorization holder

Bayer AG, 51368 Leverkusen, Germany

Marketing authorization dates and numbers

EU/1/08/472/040

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

Drugs

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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