MYLAN-EZETIMIBE TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
08-01-2015
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Werkstoffen:
EZETIMIBE
Beschikbaar vanaf:
MYLAN PHARMACEUTICALS ULC
ATC-code:
C10AX09
INN (Algemene Internationale Benaming):
EZETIMIBE
Dosering:
10MG
farmaceutische vorm:
TABLET
Samenstelling:
EZETIMIBE 10MG
Toedieningsweg:
ORAL
Eenheden in pakket:
30/100/500
Prescription-type:
Prescription
Therapeutisch gebied:
CHOLESTEROL ABSORPTION INHIBITORS
Product samenvatting:
Active ingredient group (AIG) number: 0149164001; AHFS:
Autorisatie-status:
CANCELLED POST MARKET
Autorisatie datum:
2017-05-08
Productkenmerken
Page 1 of 30
PRODUCT MONOGRAPH
PR MYLAN-EZETIMIBE
Ezetimibe Tablets
10 mg
Cholesterol Absorption Inhibitor
Professed
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke ON
M9Z 2S6
Date of Revision: January 08, 2015
Submission Control No: 180299
Page 2 of 30
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
OVEROSAGE
.................................................................................................................
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
.......................................................................................................
18
TOXICOLOGY
...............................................................................................................
22
REFERENCES
........................
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