XARELTO TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RIVAROXABAN

Available from:

BAYER INC

ATC code:

B01AF01

INN (International Name):

RIVAROXABAN

Dosage:

15MG

Pharmaceutical form:

TABLET

Composition:

RIVAROXABAN 15MG

Administration route:

ORAL

Units in package:

28/42/90

Prescription type:

Prescription

Therapeutic area:

Direct Factor Xa Inhibitors

Product summary:

Active ingredient group (AIG) number: 0152487002; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-01-16

Summary of Product characteristics

_XARELTO (rivaroxaban tablets; rivaroxaban granules for oral
suspension) _
_Page 1 of 119_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
XARELTO®
Rivaroxaban tablets
Tablets 2.5 mg, 10 mg, 15 mg and 20 mg, Oral
Rivaroxaban granules for oral suspension
Granules for oral suspension, 1mg/mL when reconstituted, Oral
Anticoagulant
(ATC Classification: B01AF01)
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
http://www.bayer.ca
Date of Initial Authorization:
SEP 15, 2008
Date of Revision:
April 17, 2023
Submission Control Number: 268349
© 2023, Bayer Inc.
®
TM see www.bayer.ca/tm-mc
_XARELTO (rivaroxaban tablets; rivaroxaban granules for oral
suspension) _
_Page 2 of 119_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.3 Reconstitution
04/2023
7 WARNINGS AND PRECAUTIONS, Bleeding
12/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1 INDICATIONS
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4
1.1 Pediatrics
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4
1.2 Geriatrics
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5
2 CONTRAINDICATIONS
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5
4 DOSAGE AND ADMINISTRATION
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