TEVA-FENOFIBRATE-S TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

FENOFIBRATE

Доступна з:

TEVA CANADA LIMITED

Код атс:

C10AB05

ІПН (Міжнародна Ім'я):

FENOFIBRATE

Дозування:

160MG

Фармацевтична форма:

TABLET

Склад:

FENOFIBRATE 160MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

30/100

Тип рецепту:

Prescription

Терапевтична области:

FRIBIC ACID DERIVATIVES

Огляд продуктів:

Active ingredient group (AIG) number: 0118895004; AHFS:

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2018-04-30

Характеристики продукта

1
PRODUCT MONOGRAPH
Pr
TEVA-FENOFIBRATE-S
Fenofibrate
Micronized Formulation
Film-Coated Tablets
100mg and 160mg
Lipid Metabolism Regulator
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 170405
Date of Revision :
June 13, 2014
2
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
....................................................................................................
9
DRUG INTERACTIONS
..................................................................................................
14
DOSAGE AND ADMINISTRATION
..............................................................................
16
OVERDOSAGE
................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 17
STORAGE AND STABILITY
..........................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 19
PART II: SCIENTIFIC INFORMATION
...............................................................................
20
PHARMACEUTICAL INFORMATION
..........................................................................
20
CLINICAL TRIALS
..........................................................................................................
21
DETAILED PHARMACOLOGY
........................................................................