M-EZETIMIBE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
30-05-2023
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Active ingredient:
EZETIMIBE
Available from:
MANTRA PHARMA INC
ATC code:
C10AX09
INN (International Name):
EZETIMIBE
Dosage:
10MG
Pharmaceutical form:
TABLET
Composition:
EZETIMIBE 10MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
CHOLESTEROL ABSORPTION INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0149164001; AHFS:
Authorization status:
APPROVED
Authorization date:
2017-08-18
Summary of Product characteristics
Page
1
of
30
PRODUCT MONOGRAPH
PR
M-EZETIMIBE
Ezetimibe Tablets, USP
10 mg
Cholesterol Absorption Inhibitor
Mantra Pharma Inc.,
1000 du Lux, suite 201
Brossard, Quebec
J4Y 0E3
Control # 275104
Date
of
Revision:
MAY
30, 2023
Page
2
of
30
TABLE OF CONTENT
Table of Content
.....................................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................3
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
..............................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
..........................................................................14
STORAGE AND STABILITY
........................................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
...........................................................16
PART II: SCIENTIFIC INFORMATION
............................................................................................17
PHARMACEUTICAL INFORMATION
.......
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