EZETIMIBE TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
20-01-2017
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Aktiva substanser:
EZETIMIBE
Tillgänglig från:
SIVEM PHARMACEUTICALS ULC
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
PRODUCT MONOGRAPH
PR
EZETIMIBE
EZETIMIBE TABLETS
10 MG
MANUFACTURER’S STANDARD
Cholesterol Absorption Inhibitor
Sivem Pharmaceuticals ULC
Date of Revision:
4705 Dobrin Street
January 17, 2017
St. Laurent, Quebec
H4R 2P7
www.sivem.ca
SUBMISSION CONTROL NO.: 200952
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
............................................................................................................
11
DOSAGE AND ADMINISTRATION
........................................................................................
12
OVERDOSAGE
..........................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
14
STORAGE AND STABILITY
....................................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 15
PART II: SCIENTIFIC INFORMATION
...................................................................................17
PHARMACEUTICAL INFORMATION
....................................................................................
17
CLINICAL TRIALS
.................................................................................
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