AURO-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:

AURO PHARMA INC

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:

APPROVED

承認日:

2016-11-21

製品の特徴

Page 1 of 40
PRODUCT MONOGRAPH
PR
AURO-PRAVASTATIN
Pravastatin Tablets, BP
10 mg, 20 mg and 40 mg of pravastatin sodium
Lipid Metabolism Regulator
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
CANADA
Date of Revision:
August 7, 2020
SUBMISSION CONTROL NO:
239425
Page 2 of 40
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
.............................……………................ 16
DOSAGE AND ADMINISTRATION .............…............................
18
OVERDOSAGE
......................................………….........................
19
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 ..............................……………..
30
TOXICOLOGY
...........................…………………………............
31
REFERENCE…...................................………………………….....
36
PART III:
CONSUMER INFORMATION.....................………………….......
41
Page 3 of 40
PR
AURO-PRAVASTATIN
Pravastatin Tablets, BP
10 mg, 20 mg and 40 mg of pravastatin sodium
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
ALL NON-MEDICINAL INGREDIENTS