AA-FENO-SUPER TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
13-08-2021
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Active ingredient:
FENOFIBRATE
Available from:
AA PHARMA INC
ATC code:
C10AB05
INN (International Name):
FENOFIBRATE
Dosage:
200MG
Pharmaceutical form:
TABLET
Composition:
FENOFIBRATE 200MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
FRIBIC ACID DERIVATIVES
Product summary:
Active ingredient group (AIG) number: 0118895001; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-08-17
Summary of Product characteristics
Page 1 of 38
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AA-FENO-SUPER
FENOFIBRATE TABLETS
HOUSE STANDARD
100 MG, 160 MG AND 200 MG
LIPID METABOLISM REGULATOR
AA PHARMA INC.
DATE OF REVISION:
1165 CREDITSTONE ROAD UNIT #1
AUGUST 13, 2021
VAUGHAN, ONTARIO
L4K 4N7
CONTROL # 254380
Page 2 of 38
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
.........................................................................................................................................
8
DRUG INTERACTIONS
........................................................................................................................................
12
DOSAGE AND ADMINISTRATION
....................................................................................................................
16
OVERDOSAGE
......................................................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................................
17
STORAGE AND STABILITY
................................................................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.....................................
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