MYLAN-ATORVASTATIN TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

ATORVASTATIN (ATORVASTATIN CALCIUM)

から入手可能:

MYLAN PHARMACEUTICALS ULC

ATCコード:

C10AA05

INN（国際名）:

ATORVASTATIN

投薬量:

80MG

医薬品形態:

TABLET

構図:

ATORVASTATIN (ATORVASTATIN CALCIUM) 80MG

投与経路:

ORAL

パッケージ内のユニット:

90

処方タイプ:

Prescription

治療領域:

HMG-COA REDUCTASE INHIBITORS

製品概要:

Active ingredient group (AIG) number: 0133055004; AHFS:

認証ステータス:

APPROVED

承認日:

2012-10-30

製品の特徴

_MYLAN-ATORVASTATIN _
_Atorvastatin (as Atorvastatin Calcium Trihydrate) _
_Page 1 of 55_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR MYLAN-ATORVASTATIN
Atorvastatin Calcium Tablets
Tablets, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin
calcium trihydrate), Oral
USP
Lipid Metabolism Regulator
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
OCT 30, 2012
Date of Revision:
OCT 23, 2023
Submission Control Number: 275378
_MYLAN-ATORVASTATIN _
_Atorvastatin (as Atorvastatin Calcium Trihydrate) _
_Page 2 of 55_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
10/2023
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
10/2023
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
........................................................ 6
4.4
Administration