PRAVASTATIN TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

PRAVASTATIN SODIUM

から入手可能:

COBALT PHARMACEUTICALS COMPANY

ATCコード:

C10AA03

INN（国際名）:

PRAVASTATIN

投薬量:

10MG

医薬品形態:

TABLET

構図:

PRAVASTATIN SODIUM 10MG

投与経路:

ORAL

パッケージ内のユニット:

30/100/500

処方タイプ:

Prescription

治療領域:

HMG-COA REDUCTASE INHIBITORS

製品概要:

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

認証ステータス:

CANCELLED PRE MARKET

承認日:

2017-09-01

製品の特徴

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_Page 1 of 44_
PRODUCT MONOGRAPH
Pr
PRAVASTATIN
Pravastatin Sodium
10 mg, 20 mg and 40 mg Tablets
USP
Lipid Metabolism Regulator
Manufactured by:
Cobalt Pharmaceuticals Company
6500 Kitimat Road
Mississauga, Ontario
L5N 2B8
Date of Revision:
February 20, 2012
Submission Control No: 153301
_ _
_Page 2 of 44_
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
........................................................... 19
STORAGE AND
STABILITY.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL
INFORMATION.........................................................................
23
CLINICAL
TRIALS.........................................................................................................
24
DETAILED
PHARMACOLOGY.................................................