MYLAN-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:

MYLAN PHARMACEUTICALS ULC

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

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:

2017-08-02

产品特点

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PRODUCT MONOGRAPH
PR
MYLAN-PRAVASTATIN
pravastatin sodium tablets
10 mg, 20 mg and 40 mg
USP
Lipid Metabolism Regulator
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control Number: 205285
Date of Revision: May 12, 2017
_Page 2 of _
_49_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
6
ADVERSE REACTIONS
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
17
DOSAGE AND ADMINISTRATION
.............................................................................
19
OVERDOSAGE
................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION ............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
.........................................................................................................
26
DETAILED PHARMACOLOGY
................................................................................