SANDOZ ROSUVASTATIN TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

ROSUVASTATIN (ROSUVASTATIN CALCIUM)

Доступна с:

SANDOZ CANADA INCORPORATED

код АТС:

C10AA07

ИНН (Международная Имя):

ROSUVASTATIN

дозировка:

40MG

Фармацевтическая форма:

TABLET

состав:

ROSUVASTATIN (ROSUVASTATIN CALCIUM) 40MG

Администрация маршрут:

ORAL

Штук в упаковке:

30/100

Тип рецепта:

Prescription

Терапевтические области:

HMG-COA REDUCTASE INHIBITORS

Обзор продуктов:

Active ingredient group (AIG) number: 0148963003; AHFS:

Статус Авторизация:

APPROVED

Дата Авторизация:

2012-03-15

Характеристики продукта

_Sandoz Rosuvastatin (rosuvastatin calcium) Product Monograph _
_Page 1 of 57_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ ROSUVASTATIN
Rosuvastatin Calcium Tablets
Tablets, 5, 10, 20 and 40 mg rosuvastatin (as rosuvastatin calcium),
Oral
Manufacturer’s Standard
Lipid Metabolism Regulator
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, (Québec), Canada
J4B 1K6
Date of Initial Authorization:
SEP 29, 2020
Date of Revision:
December 13, 2023
Submission Control Number: 278851
_Sandoz Rosuvastatin (rosuvastatin calcium) Product Monograph _
_Page 2 of 57_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
02/2023
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
12/2023
4.2 Recommended Dose and Dosage Adjustment
12/2023
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
..........................................................................................................................
4
2
CONTRAINDICATIONS
.............................................................................................................
5
4
DOSAGE AND ADMINISTRATION
.............................................................................................
5
4.1
Dosing Considerations
..............................................................................