MYLAN-ATORVASTATIN TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Доступна с:

MYLAN PHARMACEUTICALS ULC

код АТС:

C10AA05

ИНН (Международная Имя):

ATORVASTATIN

дозировка:

20MG

Фармацевтическая форма:

TABLET

состав:

ATORVASTATIN (ATORVASTATIN CALCIUM) 20MG

Администрация маршрут:

ORAL

Штук в упаковке:

90/500

Тип рецепта:

Prescription

Терапевтические области:

HMG-COA REDUCTASE INHIBITORS

Обзор продуктов:

Active ingredient group (AIG) number: 0133055002; AHFS:

Статус Авторизация:

APPROVED

Дата Авторизация:

2012-10-30

Характеристики продукта

_MYLAN-ATORVASTATIN _
_Atorvastatin (as Atorvastatin Calcium Trihydrate) _
_Page 1 of 55_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR MYLAN-ATORVASTATIN
Atorvastatin Calcium Tablets
Tablets, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin
calcium trihydrate), Oral
USP
Lipid Metabolism Regulator
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
OCT 30, 2012
Date of Revision:
OCT 23, 2023
Submission Control Number: 275378
_MYLAN-ATORVASTATIN _
_Atorvastatin (as Atorvastatin Calcium Trihydrate) _
_Page 2 of 55_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
10/2023
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
10/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics
.................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
5
2
CONTRAINDICATIONS
..................................................................................................
5
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 6
4.4
Administration