EZETIMIBE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
06-02-2020
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Active ingredient:
EZETIMIBE
Available from:
LABORATOIRE RIVA INC.
ATC code:
C10AX09
INN (International Name):
EZETIMIBE
Dosage:
10MG
Pharmaceutical form:
TABLET
Composition:
EZETIMIBE 10MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
CHOLESTEROL ABSORPTION INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0149164001; AHFS:
Authorization status:
APPROVED
Authorization date:
2018-07-11
Summary of Product characteristics
_Product Monograph – EZETIMIBE _
_Page 1 of 30 _
PRODUCT MONOGRAPH
PR EZETIMIBE
Ezetimibe Tablets, USP
10 mg
Cholesterol Absorption Inhibitor
www.labriva.com
SUBMISSION CONTROL NO:
235246
Canada, J7C 3V4
Blainville, Quebec
660 Boul. Industriel
LABORATOIRE RIVA INC.
February 6, 2020
DATE OF REVISION:
_Product Monograph – EZETIMIBE _
_Page 2 of 30 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
.......................................................................................
3
INFORMATION SUMMARY PRODUCT INFORMATION
.......................................... 3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
13
OVERDOSAGE
...............................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 14
STORAGE AND STABILITY
.........................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 16
PART II: SCIENTIFIC INFORMATION
...............................................................................
17
PHARMACEUTICAL INFORMATION
.........................................................................
17
CLINICAL TRIALS
.........................................................................................................
19
TOXICOLOGY
..........
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