XARELTO TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

RIVAROXABAN

Доступна с:

BAYER INC

код АТС:

B01AF01

ИНН (Международная Имя):

RIVAROXABAN

дозировка:

15MG

Фармацевтическая форма:

TABLET

состав:

RIVAROXABAN 15MG

Администрация маршрут:

ORAL

Штук в упаковке:

28/42/90

Тип рецепта:

Prescription

Терапевтические области:

Direct Factor Xa Inhibitors

Обзор продуктов:

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

Статус Авторизация:

APPROVED

Дата Авторизация:

2012-01-16

Характеристики продукта

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