SANDOZ 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:

SANDOZ CANADA INCORPORATED

ATC代码:

C10AA05

INN（国际名称）:

ATORVASTATIN

剂量:

10MG

药物剂型:

TABLET

组成:

ATORVASTATIN (ATORVASTATIN CALCIUM) 10MG

给药途径:

ORAL

每包单位数:

30/100/500

处方类型:

Prescription

治疗领域:

HMG-COA REDUCTASE INHIBITORS

產品總結:

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

授权状态:

APPROVED

授权日期:

2010-05-19

产品特点

_Sandoz Atorvastatin _
_ _
_Page 1 of 63_
_ _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ ATORVASTATIN
Atorvastatin Calcium Tablets
Tablets, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin
calcium trihydrate), Oral
Manufacturer’s Standard
Lipid Metabolism Regulator
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Québec, Canada
J4B 1E6
Date of Initial Authorization:
May 19, 2010
Date of Revision:
September 11, 2023
Submission Control Number: 274576
_Sandoz Atorvastatin _
_ _
_Page 2 of 63_
_ _
RECENT MAJOR LABEL CHANGES
2 Contraindications
7 Warnings and Precautions, Musculoskeletal
09/2023
7 Warnings and Precautions, Musculoskeletal
09/2023
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
......................................................................................
6
4.1
Dosing Considerations
...............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
.......................................................... 6
4.4