SANDOZ PRAVASTATIN TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

PRAVASTATIN SODIUM

可用日期:

SANDOZ CANADA INCORPORATED

ATC代码:

C10AA03

INN（国际名称）:

PRAVASTATIN

剂量:

10MG

药物剂型:

TABLET

组成:

PRAVASTATIN SODIUM 10MG

给药途径:

ORAL

每包单位数:

30/100/250/500

处方类型:

Prescription

治疗领域:

HMG-COA REDUCTASE INHIBITORS

產品總結:

Active ingredient group (AIG) number: 0122563001; AHFS:

授权状态:

CANCELLED POST MARKET

授权日期:

2017-05-29

产品特点

PRODUCT MONOGRAPH
PR
SANDOZ PRAVASTATIN
Pravastatin Sodium
10 mg, 20 mg and 40 mg tablets
Lipid Metabolism Regulator
Sandoz Canada Inc.
145 Jules-Léger
Date of Revision: February 16, 2017
Boucherville, QC, Canada
J4B 7K8
Control No. 202280
Sandoz Pravastatin
Page 2 of 41
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
..........................................................................................................
15
DOSAGE AND ADMINISTRATION
......................................................................................
17
OVERDOSAGE
........................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
18
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
.................................................................................
21
CLINICAL TRIALS
............................................................................................................