PMS-ATORVASTATIN TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

ATORVASTATIN (ATORVASTATIN CALCIUM)

可用日期:

PHARMASCIENCE INC

ATC代码:

C10AA05

INN（国际名称）:

ATORVASTATIN

剂量:

80MG

药物剂型:

TABLET

组成:

ATORVASTATIN (ATORVASTATIN CALCIUM) 80MG

给药途径:

ORAL

每包单位数:

15G/50G

处方类型:

Prescription

治疗领域:

HMG-COA REDUCTASE INHIBITORS

產品總結:

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

授权状态:

APPROVED

授权日期:

2018-06-08

产品特点

_pms-ATORVASTATIN (atorvastatin calcium) _
_Page 1 of 63 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-ATORVASTATIN
Atorvastatin Calcium Tablets
Tablet, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin
calcium trihydrate), Oral
USP
Lipid Metabolism Regulator
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Initial Authorization
JUN 08, 2018
Date of Revision:
MAR 25, 2022
Submission Control Number: 260400
_pms-ATORVASTATIN (atorvastatin calcium) _
_Page 2 of 63 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
10/2021
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
03/2022
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..........................