EZETIMIBE TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
10-01-2018
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Aktiv bestanddel:
EZETIMIBE
Tilgængelig fra:
PRO DOC LIMITEE
ATC-kode:
C10AX09
INN (International Name):
EZETIMIBE
Dosering:
10MG
Lægemiddelform:
TABLET
Sammensætning:
EZETIMIBE 10MG
Indgivelsesvej:
ORAL
Enheder i pakken:
30/100
Recept type:
Prescription
Terapeutisk område:
CHOLESTEROL ABSORPTION INHIBITORS
Produkt oversigt:
Active ingredient group (AIG) number: 0149164001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2018-01-10
Produktets egenskaber
_Ezetimibe _
_Page 1 of 28_
PRODUCT MONOGRAPH
Pr
EZETIMIBE
Ezetimibe Tablets
10 mg ezetimibe
Cholesterol Absorption Inhibitor
Pro Doc Ltée
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Date of Revision:
January 10, 2018
Submission Control No.: 211911
_Ezetimibe _
_Page 2 of 28_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT
INFORMATION........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
11
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
.........................................................................................................
17
TOXICOLOGY
.....................................................................................
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