TEVA-RIVAROXABAN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

RIVAROXABAN

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

B01AF01

DCI (Dénomination commune internationale):

RIVAROXABAN

Dosage:

20MG

forme pharmaceutique:

TABLET

Composition:

RIVAROXABAN 20MG

Mode d'administration:

ORAL

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Descriptif du produit:

Active ingredient group (AIG) number: 0152487003; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2023-11-01

Résumé des caractéristiques du produit

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_Teva-Rivaroxaban Product Monograph _
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_Page 1 of 99 _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-RIVAROXABAN
Rivaroxaban tablets
Tablets; 10 mg, 15 mg and 20 mg, Oral
Teva Standard
Anticoagulant
(ATC Classification: B01AF01)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Initial Authorization: October 26, 2020
Date of Revision: September 27, 2023
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Control No.: 274300
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_Teva-Rivaroxaban Product Monograph _
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_Page 2 of 99 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
09/2023
1 INDICATIONS, 1.1 Pediatrics
09/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
09/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
09/2023
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
09/2023
4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose
09/2023
7 WARNINGS AND PRECAUTIONS, Bleeding
09/2023
7 WARNINGS AND PRECAUTIONS, Drug Interactions
09/2023
7 WARNINGS AND PRECAUTIONS, Surgical / Procedural Interventions,
_Peri-_
_Operative Spinal/Epidural Anesthesia, Lumbar Puncture_
09/2023
7 WARNINGS AND PRECAUTIONS, Renal Impairment
09/2023
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.3 Pediatrics
09/2023
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
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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4
2