TEVA-RIVAROXABAN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

RIVAROXABAN

Saatavilla:

TEVA CANADA LIMITED

ATC-koodi:

B01AF01

INN (Kansainvälinen yleisnimi):

RIVAROXABAN

Annos:

10MG

Lääkemuoto:

TABLET

Koostumus:

RIVAROXABAN 10MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2023-11-01

Valmisteyhteenveto

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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