Q-PRAVASTATIN TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

PRAVASTATIN SODIUM

Доступна с:

QD PHARMACEUTICALS ULC

код АТС:

C10AA03

ИНН (Международная Имя):

PRAVASTATIN

дозировка:

40MG

Фармацевтическая форма:

TABLET

состав:

PRAVASTATIN SODIUM 40MG

Администрация маршрут:

ORAL

Штук в упаковке:

30/100

Тип рецепта:

Prescription

Терапевтические области:

HMG-COA REDUCTASE INHIBITORS

Обзор продуктов:

Active ingredient group (AIG) number: 0122563003; AHFS:

Статус Авторизация:

CANCELLED PRE MARKET

Дата Авторизация:

2015-08-21

Характеристики продукта

_Page 1 of _
_47_
PRODUCT MONOGRAPH
PR
Q-PRAVASTATIN
pravastatin sodium tablets
10 mg, 20 mg and 40 mg
USP
Lipid Metabolism Regulator
QD Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control Number: 164225
Date of Revision: May 31, 2013
_Page 2 of _
_47_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
6
ADVERSE REACTIONS
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
18
OVERDOSAGE
................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION ............................................................................
24
PHARMACEUTICAL INFORMATION
.........................................................................
24
CLINICAL TRIALS
.........................................................................................................
25
DETAILED PHARMACOLOGY
....................................................................................
32