RIVA RIVAROXABAN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RIVAROXABAN

Available from:

LABORATOIRE RIVA INC.

ATC code:

B01AF01

INN (International Name):

RIVAROXABAN

Dosage:

15MG

Pharmaceutical form:

TABLET

Composition:

RIVAROXABAN 15MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2023-11-01

Summary of Product characteristics

_Page 1 of 111_
_RIVA RIVAROXABAN (rivaroxaban)_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RIVA RIVAROXABAN
Rivaroxaban Tablets
Tablets, 2.5 mg, 10 mg, 15 mg and 20 mg, Oral
House standard
Anticoagulant
(ATC Classification: B01AF01)
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Submission Control Number: 276851
Date of Initial Authorization:
AUG
25, 2023
_RIVA RIVAROXABAN (rivaroxaban) _
_ _
_Page 2 of 111_
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 7
4.4
Administration
........................................................................................................
11
4.5
Missed Dose
..............................................................................