RIVAROXABAN TABLET

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

RIVAROXABAN

Fáanlegur frá:

BAYER INC

ATC númer:

B01AF01

INN (Alþjóðlegt nafn):

RIVAROXABAN

Skammtar:

20MG

Lyfjaform:

TABLET

Samsetning:

RIVAROXABAN 20MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

Direct Factor Xa Inhibitors

Vörulýsing:

Active ingredient group (AIG) number: 0152487003; AHFS:

Leyfisstaða:

CANCELLED PRE MARKET

Leyfisdagur:

2023-01-19

Vara einkenni

_RIVAROXABAN (rivaroxaban tablets; rivaroxaban granules for oral
suspension)_
_Page 1 of 117_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RIVAROXABAN
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
Submission Control Number:
261903
© 2022, Bayer Inc.
®
TM see www.bayer.ca/tm-mc
Date of Initial Authorization:
SEP 9, 2020
Date of Revision:
March 24, 2022
_RIVAROXABAN (rivaroxaban tablets; rivaroxaban granules for oral
suspension) _
_Page 2 of 117_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
08/2021
1 INDICATIONS, 1.1 Pediatrics
08/2021
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
08/2021
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
08/2021
4 DOSAGE AND ADMINISTRATION, 4.3 Reconstitution
08/2021
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
08/2021
4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose
08/2021
7 WARNINGS AND PRECAUTIONS, Bleeding
7 WARNINGS AND PRECAUTIONS, Drug Interactions
08/2021
7 WARNINGS AND PRECAUTIONS, Surgery / Procedural Interventions,
_Peri-Operative Spinal/Epidural Anesthesia, Lumbar Puncture_
08/2021
7 WARNINGS AND PRECAUTIONS, Renal Impairment
08/2021
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.3
Pediatrics
08/2021
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.4
Geriatrics
08/2021
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