ATORVASTATIN-10 TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Доступна с:

SIVEM PHARMACEUTICALS ULC

код АТС:

C10AA05

ИНН (Международная Имя):

ATORVASTATIN

дозировка:

10MG

Фармацевтическая форма:

TABLET

состав:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 10MG

Администрация маршрут:

ORAL

Штук в упаковке:

90/100/500

Тип рецепта:

Prescription

Терапевтические области:

HMG-COA REDUCTASE INHIBITORS

Обзор продуктов:

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

Статус Авторизация:

APPROVED

Дата Авторизация:

2013-08-29

Характеристики продукта

_Product Monograph - ATORVASTATIN-10, -20, -40, -80 _
_ _
_ _
_ _
_Page 1 of 55 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ATORVASTATIN-10
PR
ATORVASTATIN-20
PR
ATORVASTATIN-40
PR
ATORVASTATIN-80
Atorvastatin Calcium Tablets
Tablet, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin
(as atorvastatin calcium propylene glycol solvate), Oral
USP
Lipid Metabolism Regulator
Sivem Pharmaceuticals ULC
Date of Initial Authorization:
4705 Dobrin Street
August 29, 2013
Saint-Laurent, Quebec, Canada
H4R 2P7
Date of Revision:
www.sivem.ca
March 14, 2023
Submission Control Number: 268525
_Product Monograph - ATORVASTATIN-10, -20, -40, -80 _
_ _
_ _
_ _
_Page 2 of 55 _
RECENT MAJOR LABEL CHANGES
2 Contraindications
03/2023
7 Warnings and Precautions, Musculoskeletal
03/2023
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
..........................