RIVA RIVAROXABAN TABLET

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

RIVAROXABAN

Fáanlegur frá:

LABORATOIRE RIVA INC.

ATC númer:

B01AF01

INN (Alþjóðlegt nafn):

RIVAROXABAN

Skammtar:

2.5MG

Lyfjaform:

TABLET

Samsetning:

RIVAROXABAN 2.5MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Vörulýsing:

Active ingredient group (AIG) number: 0152487004; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2023-11-01

Vara einkenni

_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
..............................................................................