RATIO-ATORVASTATIN TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Доступна з:

TEVA CANADA LIMITED

Код атс:

C10AA05

ІПН (Міжнародна Ім'я):

ATORVASTATIN

Дозування:

10MG

Фармацевтична форма:

TABLET

Склад:

ATORVASTATIN (ATORVASTATIN CALCIUM) 10MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

30/100/500

Тип рецепту:

Prescription

Терапевтична области:

HMG-COA REDUCTASE INHIBITORS

Огляд продуктів:

Active ingredient group (AIG) number: 0133055001; AHFS:

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2018-06-18

Характеристики продукта

PRODUCT MONOGRAPH
Pr
RATIO-ATORVASTATIN
Atorvastatin Calcium Tablets
10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin calcium)
LIPID METABOLISM REGULATOR
Teva Canada Limited.
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Revision:
September 8, 2017
Submission Control: 208763
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................14
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
STORAGE AND STABILITY
..........................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................23
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
..........................................................................25
CLINICAL TRIALS
..........................................................................................................26
DETAILED PHARMACOLOGY
.....................................................................................39
TOXICOLOGY
........................................................................