ATORVASTATIN TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Доступна з:

APOTEX INC

Код атс:

C10AA05

ІПН (Міжнародна Ім'я):

ATORVASTATIN

Дозування:

80MG

Фармацевтична форма:

TABLET

Склад:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 80MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

250ML

Тип рецепту:

Prescription

Терапевтична области:

HMG-COA REDUCTASE INHIBITORS

Огляд продуктів:

Active ingredient group (AIG) number: 0133055004; AHFS:

Статус Авторизація:

MARKETED

Дата Авторизація:

2013-01-07

Характеристики продукта

Page 1 of 46
PRODUCT MONOGRAPH
Pr
ATORVASTATIN
(ATORVASTATIN CALCIUM TABLETS)
10 MG, 20 MG, 40 MG AND 80 MG
(ATORVASTATIN AS ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)
LIPID METABOLISM REGULATOR
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
NOVEMBER 5, 2012
TORONTO, ONTARIO
M9L 1T9
SUBMISSION CONTROL NO: 159558
Page 2 of 46
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
3
SUMMARY PRODUCT INFORMATION
...........................................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................................
3
CONTRAINDICATIONS
......................................................................................................................
4
WARNINGS AND PRECAUTIONS
.....................................................................................................
5
ADVERSE REACTIONS
......................................................................................................................
9
DRUG INTERACTIONS
.....................................................................................................................
12
DOSAGE AND ADMINISTRATION
.................................................................................................
16
OVERDOSAGE
...................................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................
18
STORAGE AND STABILITY
.............................................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
..........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................ 21
PART II: SCIENTIFIC INFORMATION