SANDOZ APIXABAN SDZ TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
06-12-2019
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Active ingredient:
APIXABAN
Available from:
SANDOZ CANADA INCORPORATED
ATC code:
B01AF02
INN (International Name):
APIXABAN
Dosage:
2.5MG
Pharmaceutical form:
TABLET
Composition:
APIXABAN 2.5MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0153051001; AHFS:
Authorization status:
APPROVED
Authorization date:
2022-09-20
Summary of Product characteristics
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_Sandoz Apixaban SDZ _
_Page 1 of 72_
PRODUCT MONOGRAPH
PR
SANDOZ
® APIXABAN SDZ
Apixaban Tablets
2.5 mg and 5 mg
Anticoagulant
Sandoz Canada Inc.
110 de Lauzon street
Boucherville,
Quebec
J4B 1E6
Date of Preparation:
December 6, 2019
Submission
Control No: 221580, 234041
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_Sandoz Apixaban SDZ _
_Page 2 of 72 _
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
............................................................................................18
DOSAGE AND ADMINISTRATION
.........................................................................22
OVERDOSAGE
..........................................................................................................28
ACTION AND CLINICAL PHARMACOLOGY
.........................................................30
STORAGE AND STABILITY
....................................................................................34
SPECIAL HANDLING INSTRUCTIONS
...................................................................34
DOSAGE FORMS, COMPOSITION AND
PACKAGING...........................................34
PART II: SCIENTIFIC INFORMATION
.........................................................................
36
PHARMACEUTICAL INFORMATION
.....................................................................36
CLINICAL
TRIALS....................................................................................................37
DETAILED PHARMACOLOGY
............
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