TARO-FENOFIBRATE E TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

FENOFIBRATE

Pieejams no:

SUN PHARMA CANADA INC

ATĶ kods:

C10AB05

SNN (starptautisko nepatentēto nosaukumu):

FENOFIBRATE

Deva:

145MG

Zāļu forma:

TABLET

Kompozīcija:

FENOFIBRATE 145MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

10/30/500

Receptes veids:

Prescription

Ārstniecības joma:

FRIBIC ACID DERIVATIVES

Produktu pārskats:

Active ingredient group (AIG) number: 0118895006; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2016-05-12

Produkta apraksts

_Page 1 of 41_
_Pr_
_TARO-FENOFIBRATE E (Fenofibrate Tablets, Mfr. Std.) Product Monograph
_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-FENOFIBRATE E
Fenofibrate Tablets, Mfr. Std.
145 mg
LIPID METABOLISM REGULATOR
Sun Pharma Canada Inc.
126 East Drive
Brampton, ON
L6T 1C1
Date of Revision:
July 13, 2020
Submission Control No: 234145
_Page 2 of 41_
_Pr_
_TARO-FENOFIBRATE E (Fenofibrate Tablets, Mfr. Std.) Product Monograph
_
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
........................................................................................
15
OVERDOSAGE
..........................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
17
STORAGE AND STABILITY
....................................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 19
PART II: SCIENTIFIC INFORMATION
..............................................................................
20
PHARMACEUTICAL INFORMATION
......