TARO-APIXABAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
30-12-2020
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Active ingredient:
APIXABAN
Available from:
SUN PHARMA CANADA INC
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
_TARO-APIXABAN (Apixaban Tablets) Product Monograph_
_Page 1 of 79_
PRODUCT MONOGRAPH
PR
TARO-APIXABAN
Apixaban Tablets
2.5 mg and 5 mg
ANTICOAGULANT
Sun Pharma Canada Inc.
126 East Drive
Brampton, ON
L6T 1C1.
Date of Preparation: December 30, 2020
Submission Control No.: 229728
_TARO-APIXABAN (Apixaban Tablets) Product Monograph_
_Page 2 of 79_
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
..............................................................................................
10
DRUG INTERACTIONS
..............................................................................................
19
DOSAGE AND
ADMINISTRATION............................................................................
23
OVERDOSAGE............................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 31
STORAGE AND
STABILITY.......................................................................................
36
SPECIAL HANDLING
INSTRUCTIONS......................................................................
36
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 37
PART II: SCIENTIFIC INFORMATION
............................................................................38
PHARMACEUTICAL INFORMATION
.......................................................................
38
CLINICAL
TRIALS.................................................................
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