APO-ATORVASTATIN TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Предлага се от:

APOTEX INC

АТС код:

C10AA05

INN (Международно Name):

ATORVASTATIN

дозиране:

40MG

Лекарствена форма:

TABLET

Композиция:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 40MG

Начин на приложение:

ORAL

Броя в опаковка:

90/100/500

Вид предписание :

Prescription

Терапевтична област:

HMG-COA REDUCTASE INHIBITORS

Каталог на резюме:

Active ingredient group (AIG) number: 0133055003; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2010-05-19

Данни за продукта

_APO-ATORVASTATIN (atorvastatin calcium) _
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_Page 1 of 56 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-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
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Canada M9L 1T9
Date of Initial Authorization:
MAY 19, 2010
Date of Revision:
APR 19,
2022
Submission Control Number: 260660
_APO-ATORVASTATIN (atorvastatin calcium) _
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_Page 2 of 56 _
_APO-ATORVASTATIN (atorvastatin calcium) _
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_Page 3 of 56 _
RECENT MAJOR LABEL CHANGES
2 Contraindications
04/2022
7 Warnings and Precautions, Musculoskeletal
04/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
....................................................................................
3
TABLE OF CONTENTS
.........................................................................................................
3
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................
5
1
INDICATIONS
.................................................................................................................
5
1.1
Pediatrics
...............................................................................................................
5
1.2
Geriatrics
................................................................................................................
6
2
CONTRAINDICATIONS
..................................................................................................
6
4
DOSAGE AND ADMINISTRATION
.................................................................................
6
4.1
Dosing Considerations
............................................................................................
6
4.2
Recommended Dose and Dosage
Adjustment......................................................... 7