Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
RIVAROXABAN
BAYER INC
B01AF01
RIVAROXABAN
2.5MG
TABLET
RIVAROXABAN 2.5MG
ORAL
100
Prescription
Direct Factor Xa Inhibitors
Active ingredient group (AIG) number: 0152487004; AHFS:
CANCELLED PRE MARKET
2023-01-19
_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 Baca dokumen lengkapnya