ATORVASTATIN TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

から入手可能:

SANIS HEALTH INC

ATCコード:

C10AA05

INN（国際名）:

ATORVASTATIN

投薬量:

10MG

医薬品形態:

TABLET

構図:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 10MG

投与経路:

ORAL

パッケージ内のユニット:

500

処方タイプ:

Prescription

治療領域:

HMG-COA REDUCTASE INHIBITORS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2012-12-18

製品の特徴

_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
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Initial Authorization:
July 30, 2020
Date of Revision:
August 22, 2022
Submission Control Number: 265202
_ATORVASTATIN (atorvastatin calcium) _
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_ Page 2 of 55 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
08/2022
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
08/2022
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
...........................................