PDP-ATORVASTATIN TABLET
国家: 加拿大
语言: 英文
来源: Health Canada
产品特点
(SPC)
03-02-2020
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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:
20MG
药物剂型:
TABLET
组成:
ATORVASTATIN (ATORVASTATIN CALCIUM) 20MG
给药途径:
ORAL
每包单位数:
100
处方类型:
Prescription
治疗领域:
HMG-COA REDUCTASE INHIBITORS
產品總結:
Active ingredient group (AIG) number: 0133055002; AHFS:
授权状态:
APPROVED
授权日期:
2020-02-04
产品特点
PRODUCT MONOGRAPH
Pr
pdp-ATORVASTATIN
Atorvastatin Calcium Tablets
10 mg, 20 mg, 40 mg and 80 mg
Lipid Metabolism Regulator
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Revision:
February 3, 2020
Submission Control No: 235024
pdp-ATORVASTATIN Product Monograph
Page 2 of 53
Table of Contents
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT INFORMATION
....................................................................3
INDICATIONS AND CLINICAL USE
.........................................................................3
CONTRAINDICATIONS
.............................................................................................5
WARNINGS AND PRECAUTIONS
.............................................................................5
ADVERSE
REACTIONS............................................................................................
11
DRUG INTERACTIONS
............................................................................................
14
DOSAGE AND ADMINISTRATION
.........................................................................
20
OVERDOSAGE
.........................................................................................................
21
ACTION AND CLINICAL
PHARMACOLOGY.........................................................
21
STORAGE AND STABILITY
....................................................................................
25
SPECIAL HANDLING INSTRUCTIONS
................................................................... 25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 25
PART II: SCIENTIFIC INFORMATION
..........................................................................
27
PHARMACEUTICAL INFORMATION
.....................................................................
27
CLINICAL TRIALS
...................................................................................................
28
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