EZETIMIBE TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
06-02-2020
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Werkstoffen:
EZETIMIBE
Beschikbaar vanaf:
LABORATOIRE RIVA INC.
ATC-code:
C10AX09
INN (Algemene Internationale Benaming):
EZETIMIBE
Dosering:
10MG
farmaceutische vorm:
TABLET
Samenstelling:
EZETIMIBE 10MG
Toedieningsweg:
ORAL
Eenheden in pakket:
30/100
Prescription-type:
Prescription
Therapeutisch gebied:
CHOLESTEROL ABSORPTION INHIBITORS
Product samenvatting:
Active ingredient group (AIG) number: 0149164001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2018-07-11
Productkenmerken
_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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