MYLAN-EZETIMIBE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
08-01-2015
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Active ingredient:
EZETIMIBE
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
C10AX09
INN (International Name):
EZETIMIBE
Dosage:
10MG
Pharmaceutical form:
TABLET
Composition:
EZETIMIBE 10MG
Administration route:
ORAL
Units in package:
30/100/500
Prescription type:
Prescription
Therapeutic area:
CHOLESTEROL ABSORPTION INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0149164001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2017-05-08
Summary of Product characteristics
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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