XARELTO TABLET

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

RIVAROXABAN

มีจำหน่ายจาก:

BAYER INC

รหัส ATC:

B01AF01

INN (ชื่อสากล):

RIVAROXABAN

ปริมาณ:

2.5MG

แบบฟอร์มเภสัชกรรม:

TABLET

องค์ประกอบ:

RIVAROXABAN 2.5MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

14/100

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

Direct Factor Xa Inhibitors

สรุปสินค้า:

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

สถานะการอนุญาต:

APPROVED

วันที่อนุญาต:

2018-09-14

สรุปลักษณะสินค้า

_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:
MAR 27, 2024
Submission Control Number: 280484
© 2024, 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, Anticoagulant-Related Nephropathy
03/2024
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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