RIVA APIXABAN TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

APIXABAN

Beschikbaar vanaf:

LABORATOIRE RIVA INC.

ATC-code:

B01AF02

INN (Algemene Internationale Benaming):

APIXABAN

Dosering:

2.5MG

farmaceutische vorm:

TABLET

Samenstelling:

APIXABAN 2.5MG

Toedieningsweg:

ORAL

Eenheden in pakket:

15G/50G

Prescription-type:

Prescription

Product samenvatting:

Active ingredient group (AIG) number: 0153051001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2022-10-04

Productkenmerken

_RIVA APIXABAN - Product Monograph _
_Page 1 of 77_
PRODUCT MONOGRAPH
PR
RIVA APIXABAN
Apixaban Tablets
2.5 mg and 5 mg
Anticoagulant
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Submission Control No.: 268218
DATE OF
INITIAL APPROVAL:
FEB 25, 2022
DATE OF REVISION:
OCT 4, 2022
_RIVA APIXABAN - Product Monograph _
_Page 2 of 77_
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
.................................................................................................
19
DOSAGE AND ADMINISTRATION
.............................................................................
24
OVERDOSAGE
...............................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 32
STORAGE AND STABILITY
.........................................................................................
36
SPECIAL HANDLING INSTRUCTIONS
......................................................................
36
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 37
PART II: SCIENTIFIC INFORMATION
...............................................................................
38
PHARMACEUTICAL INFORMATION
.........................................................................
38
CLINICAL TRIALS
..........