TEVA-APIXABAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
16-09-2022
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Active ingredient:
APIXABAN
Available from:
TEVA CANADA LIMITED
ATC code:
B01AF02
INN (International Name):
APIXABAN
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
APIXABAN 5MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0153051002; AHFS:
Authorization status:
APPROVED
Authorization date:
2022-09-20
Summary of Product characteristics
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_Teva-Apixaban Tablets _
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PRODUCT MONOGRAPH
Pr
TEVA-APIXABAN
Apixaban tablets
2.5 mg and 5 mg
Teva Standard
Anticoagulant
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Initial Approval:
January 21, 2019
Date of Revision:
September 16, 2022
Submission Control No: 266721
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_Teva-Apixaban Tablets _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................25
OVERDOSAGE
................................................................................................................33
ACTION AND CLINICAL PHARMACOLOGY
............................................................34
STORAGE AND STABILITY
..........................................................................................40
SPECIAL HANDLING INSTRUCTIONS
.......................................................................40
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................40
PART II: SCIENTIFIC INFORMATION
...............................................................................41
PHARMACEUTICAL INFORMATION
..........................................................................41
CLINICAL TRIALS
.........................
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