PRO-RIVAROXABAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
30-08-2023
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
RIVAROXABAN
Available from:
PRO DOC LIMITEE
ATC code:
B01AF01
INN (International Name):
RIVAROXABAN
Dosage:
2.5MG
Pharmaceutical form:
TABLET
Composition:
RIVAROXABAN 2.5MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0152487004; AHFS:
Authorization status:
APPROVED
Authorization date:
2023-11-01
Summary of Product characteristics
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRO-RIVAROXABAN
Rivaroxaban Tablets
Tablets, 2.5 mg, 10 mg, 15 mg and 20 mg, Oral
House standard
Anticoagulant
(ATC Classification: B01AF01)
PRO DOC LTÉE
2925, boul. Industriel
Laval, Québec
H7L 3W9
Submission Control Number: 276861
Date of Initial Authorization:
AUG 30, 2023
_PRO-RIVAROXABAN _
_ _
_Page 2 of 119_
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
.......................................................................................................................................
5
1.2
Geriatrics
.......................................................................................................................................
5
2 CONTRAINDICATIONS
...................................................................................................................5
4 DOSAGE AND ADMINISTRATION
...................................................................................................6
4.1
Dosing Considerations
...................................................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
..............................................................................
8
4.4
Administration
.............................................................................................................................
13
4.
Read the complete document
