ACH-EZETIMIBE TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
03-07-2019
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Aktiva substanser:
EZETIMIBE
Tillgänglig från:
ACCORD HEALTHCARE INC
ATC-kod:
C10AX09
INN (International namn):
EZETIMIBE
Dos:
10MG
Läkemedelsform:
TABLET
Sammansättning:
EZETIMIBE 10MG
Administreringssätt:
ORAL
Enheter i paketet:
30/100
Receptbelagda typ:
Prescription
Terapiområde:
CHOLESTEROL ABSORPTION INHIBITORS
Produktsammanfattning:
Active ingredient group (AIG) number: 0149164001; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2014-09-15
Produktens egenskaper
_ACH-Ezetimibe Product Monograph_
Page 1 of 28
PRODUCT MONOGRAPH
PR
ACH-EZETIMIBE
Ezetimibe Tablets
10 mg
USP
Cholesterol Absorption Inhibitor
Accord Healthcare, Inc.,
3535 boul. St. Charles, suite 704,
Kirkland, QC, H9H 5B9,
Canada
Date of revision:
July 3, 2019
SUBMISSION CONTROL NO: 227193
_ACH-Ezetimibe Product Monograph_
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
.......................................................................................................
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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