TARO-RIVAROXABAN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

RIVAROXABAN

Disponible depuis:

TARO PHARMACEUTICALS INC

Code ATC:

B01AF01

DCI (Dénomination commune internationale):

RIVAROXABAN

Dosage:

10MG

forme pharmaceutique:

TABLET

Composition:

RIVAROXABAN 10MG

Mode d'administration:

ORAL

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Descriptif du produit:

Active ingredient group (AIG) number: 0152487001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2023-11-01

Résumé des caractéristiques du produit

_Taro-Rivaroxaban (rivaroxaban tablets, Ph. Eur) _
_Page 1 of 100_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-RIVAROXABAN
Rivaroxaban tablets Ph.Eur
Tablets 2.5 mg, 10 mg, 15 mg and 20 mg; Oral
Ph. Eur.
Anticoagulant
(ATC Classification: B01AF01)
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, ON
L6T 1C1
Date of Initial Authorization:
December 06, 2018
Date of Revision:
October 26, 2023
Submission Control Number: 276334
_Taro-Rivaroxaban (rivaroxaban tablets, Ph. Eur) _
_Page 2 of 100_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
04/2022
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
04/2022
4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose
04/2022
7 WARNINGS AND PRECAUTIONS, Bleeding
04/2022
7 WARNINGS AND PRECAUTIONS, Drug Interactions
04/2022
7 WARNINGS AND PRECAUTIONS, Surgery / Procedural
Interventions, Peri-Operative Spinal/Epidural Anesthesia, Lumbar
Puncture
04/2022
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.4
Geriatrics
04/2022
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
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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