BEZALIP SR TABLET (EXTENDED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
31-10-2019
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Active ingredient:
BEZAFIBRATE
Available from:
ALLERGAN INC
ATC code:
C10AB02
INN (International Name):
BEZAFIBRATE
Dosage:
400MG
Pharmaceutical form:
TABLET (EXTENDED-RELEASE)
Composition:
BEZAFIBRATE 400MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
FRIBIC ACID DERIVATIVES
Product summary:
Active ingredient group (AIG) number: 0122820001; AHFS:
Authorization status:
APPROVED
Authorization date:
1998-06-01
Summary of Product characteristics
_Page 1 of 34_
PRODUCT MONOGRAPH
PR
BEZALIP
®
SR
Bezafibrate
Sustained release tablet - 400 mg
Lipid Metabolism Regulator
Allergan Inc.
85 Enterprise Blvd., Suite 500
Markham, Ontario
L6G 0B5
Imported and Marketed By:
Aralez Pharmaceuticals Canada Inc.
Mississauga, Ontario
L5N 0E4
www.aralez.com
Date of Preparation:
October 31, 2019
Submission Control No.: 232456
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_Page 2 of 34_
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
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
..........................................................................................................15
DETAILED PHARMACOLOGY
.....................................................................................20
TOXI
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