EZETIMIBE TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
11-01-2022
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Werkstoffen:
EZETIMIBE
Beschikbaar vanaf:
SANIS HEALTH INC
ATC-code:
C10AX09
INN (Algemene Internationale Benaming):
EZETIMIBE
Dosering:
10MG
farmaceutische vorm:
TABLET
Samenstelling:
EZETIMIBE 10MG
Toedieningsweg:
ORAL
Eenheden in pakket:
15G/50G
Prescription-type:
Prescription
Therapeutisch gebied:
CHOLESTEROL ABSORPTION INHIBITORS
Product samenvatting:
Active ingredient group (AIG) number: 0149164001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2015-01-07
Productkenmerken
1
PRODUCT MONOGRAPH
PR
EZETIMIBE
EZETIMIBE TABLETS
10 MG
MANUFACTURER’S STANDARD
Cholesterol Absorption Inhibitor
Sanis Health Inc.
Date of Revision:
1 President’s Choice Circle
January 11, 2022
Brampton, Ontario
L6Y 5S5
Submission Control No.: 259721
2
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
..............................................................................................................
7
DRUG INTERACTIONS
............................................................................................................
10
DOSAGE AND ADMINISTRATION
........................................................................................
12
OVERDOSAGE
..........................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
13
STORAGE AND STABILITY
....................................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 15
PART II: SCIENTIFIC INFORMATION
...................................................................................16
PHARMACEUTICAL INFORMATION
....................................................................................
16
CLINICAL TRIALS
.........................................................................................
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