Q-PRAVASTATIN TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

PRAVASTATIN SODIUM

Предлага се от:

QD PHARMACEUTICALS ULC

АТС код:

C10AA03

INN (Международно Name):

PRAVASTATIN

дозиране:

20MG

Лекарствена форма:

TABLET

Композиция:

PRAVASTATIN SODIUM 20MG

Начин на приложение:

ORAL

Броя в опаковка:

30/100/500

Вид предписание :

Prescription

Терапевтична област:

HMG-COA REDUCTASE INHIBITORS

Каталог на резюме:

Active ingredient group (AIG) number: 0122563002; AHFS:

Статус Оторизация:

CANCELLED PRE MARKET

Дата Оторизация:

2015-08-21

Данни за продукта

_Page 1 of _
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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