PMS-RIVAROXABAN TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

RIVAROXABAN

Dostupné s:

PHARMASCIENCE INC

ATC kód:

B01AF01

INN (Mezinárodní Name):

RIVAROXABAN

Dávkování:

2.5MG

Léková forma:

TABLET

Složení:

RIVAROXABAN 2.5MG

Podání:

ORAL

Jednotky v balení:

15G/50G

Druh předpisu:

Prescription

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2023-11-01

Charakteristika produktu

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-RIVAROXABAN
Rivaroxaban Tablets
Tablets, 2.5 mg, 10 mg, 15 mg and 20 mg, Oral
House standard
Anticoagulant
(ATC Classification: B01AF01)
PHARMASCIENCE INC.
Date of Initial Authorization:
6111 Royalmount Ave. Suite 100
February 1, 2021
Montréal, Canada
H4P 2T4
Date of revision:
June 2, 2023
www.pharmascience.com
Submission Control Number: 273389
_pms-RIVAROXABAN _
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RECENT MAJOR LABEL CHANGES
1 INDICATIONS
08/2022
1 INDICATIONS, 1.1 Pediatrics
08/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
08/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
08/2022
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
08/2022
4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose
08/2022
7 WARNINGS AND PRECAUTIONS, Bleeding
08/2022
7 WARNINGS AND PRECAUTIONS, Drug Interactions
08/2022
7 WARNINGS AND PRECAUTIONS, Surgery / Procedural Interventions,
_Peri-Operative _
_Spinal/Epidural Anesthesia, Lumbar Puncture _
08/2022
7 WARNINGS AND PRECAUTIONS, Renal Impairment
08/2022
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.3 Pediatrics
08/2022
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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5
1.2
Geriatrics.................................................................