JAMP-SIMVASTATIN TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

SIMVASTATIN

から入手可能:

JAMP PHARMA CORPORATION

ATCコード:

C10AA01

INN（国際名）:

SIMVASTATIN

投薬量:

20MG

医薬品形態:

TABLET

構図:

SIMVASTATIN 20MG

投与経路:

ORAL

パッケージ内のユニット:

21/30/100/500/1000

処方タイプ:

Prescription

治療領域:

HMG-COA REDUCTASE INHIBITORS

製品概要:

Active ingredient group (AIG) number: 0122415003; AHFS:

認証ステータス:

CANCELLED POST MARKET

承認日:

2013-07-08

製品の特徴

_Jamp-Simvastatin (simvastatin) tablets_
_Page 1 of 47_
PRODUCT MONOGRAPH
PR
JAMP-SIMVASTATIN
Simvastatin Tablets, USP
5 mg, 10 mg, 20 mg, 40 mg and 80 mg
Lipid Metabolism Regulator
JAMP Pharma Corporation
Date of Revision:
1310 rue Nobel
June 14, 2019
Boucherville, Québec,
Canada
J4B 5H3
Submission Control No: 227575
_Jamp-Simvastatin (simvastatin) tablets_
_Page 2 of 47_
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
......................................................................................................
12
DRUG INTERACTIONS
......................................................................................................
15
DOSAGE AND ADMINISTRATION
..................................................................................
19
OVERDOSAGE
.....................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 21
STORAGE AND STABILITY
..............................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 22
PART II: SCIENTIFIC INFORMATION
....................................................................................
23
PHARMACEUTICAL INFORMATION
.............................................................................
23
CLINICAL TRIALS
............................................