MINT-FENOFIBRATE E TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-06-2017
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Active ingredient:
FENOFIBRATE
Available from:
MINT PHARMACEUTICALS INC
ATC code:
C10AB05
INN (International Name):
FENOFIBRATE
Dosage:
145MG
Pharmaceutical form:
TABLET
Composition:
FENOFIBRATE 145MG
Administration route:
ORAL
Units in package:
90
Prescription type:
Prescription
Therapeutic area:
FRIBIC ACID DERIVATIVES
Product summary:
Active ingredient group (AIG) number: 0118895006; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2020-04-28
Summary of Product characteristics
PRODUCT MONOGRAPH
Pr
MINT-FENOFIBRATE E
fenofibrate
film-coated tablets (145 mg)
USP
LIPID METABOLISM REGU
LATOR
Mint Pharmaceuticals Inc.
Date of Preparation:
1093 Meyerside Dr., Unit #1
JUNE 15, 2017
Mississauga, Ontario
L5T 1J6
Submission Control No: 186636
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
..................................................................................................
10
DRUG INTERACTIONS
..................................................................................................
14
DOSAGE AND ADMINISTRATION
..............................................................................
18
OVERDOSAGE
.................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 19
STORAGE AND STABILITY
..........................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 21
PART II: SCIENTIFIC INFORMATION
........................................................................
23
PHARMACEUTICAL INFORMATION
..........................................................................
23
CLINICAL TRIALS
..........................................................................................................
24
DETAILED PHARMACOLOGY
.....................................................................................
29
TO
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