ATORVASTATIN TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Предлага се от:

PRO DOC LIMITEE

АТС код:

C10AA05

INN (Международно Name):

ATORVASTATIN

дозиране:

10MG

Лекарствена форма:

TABLET

Композиция:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 10MG

Начин на приложение:

ORAL

Броя в опаковка:

100/500

Вид предписание :

Prescription

Терапевтична област:

HMG-COA REDUCTASE INHIBITORS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2010-06-03

Данни за продукта

_ATORVASTATIN (atorvastatin calcium) _
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_Page 1 of 55 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ATORVASTATIN
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
PRO DOC LTÉE.
2925, Boul. Industriel
Laval, Québec
Canada H7L 3W9
Date of Initial Authorization:
July 27, 2010
Date of Revision:
June 27, 2022
Submission Control Number: 264735
_ATORVASTATIN (atorvastatin calcium) _
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_Page 2 of 55 _
RECENT MAJOR LABEL CHANGES
2 Contraindications
06/2022
7 Warnings and Precautions, Musculoskeletal
06/2022
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
...................................................