FENOFIBRATE-S TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

FENOFIBRATE

Доступна с:

SANIS HEALTH INC

код АТС:

C10AB05

ИНН (Международная Имя):

FENOFIBRATE

дозировка:

100MG

Фармацевтическая форма:

TABLET

состав:

FENOFIBRATE 100MG

Администрация маршрут:

ORAL

Штук в упаковке:

30/100/500

Тип рецепта:

Prescription

Терапевтические области:

FRIBIC ACID DERIVATIVES

Обзор продуктов:

Active ingredient group (AIG) number: 0118895002; AHFS:

Статус Авторизация:

CANCELLED POST MARKET

Дата Авторизация:

2017-07-31

Характеристики продукта

1
PRODUCT MONOGRAPH
Pr
FENOFIBRATE-S
Fenofibrate
Micronized Formulation
Film-Coated Tablets
100mg and 160mg
Lipid Metabolism Regulator
Sanis Health Inc.
333 Champlain Street, Suite 102
Dieppe, New Brunswick
Canada, E1A 1P2
Submission Control No: 176107
Date of Preparation:
August 1, 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
..................................................