SIMVASTATIN TABLETS

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

SIMVASTATIN

제공처:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC 코드:

C10AA01

INN (국제 이름):

SIMVASTATIN

복용량:

10MG

약제 형태:

TABLET

구성:

SIMVASTATIN 10MG

관리 경로:

ORAL

패키지 단위:

21/30/1000

처방전 유형:

Prescription

치료 영역:

HMG-COA REDUCTASE INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0122415004; AHFS:

승인 상태:

APPROVED

승인 날짜:

2009-08-13

제품 특성 요약

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_Page 1 of 45_
PRODUCT MONOGRAPH
SIMVASTATIN TABLETS
(SIMVASTATIN)
USP
5 MG, 10 MG, 20 MG, 40 MG AND 80 MG
LIPID METABOLISM REGULATOR
Ranbaxy Pharmaceuticals Canada Inc., Date of Preparation: August 21,
2009
2680 Matheson Blvd. East, Suite 200
Mississauga, ON L4W 0A5
Canada
SUBMISSION CONTROL NO: 131952
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_Page 2 of 45_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
......................................................................3
INDICATIONS AND CLINICAL
USE.............................................................................3
CONTRAINDICATIONS
.................................................................................................4
WARNINGS AND
PRECAUTIONS.................................................................................5
ADVERSE
REACTIONS..................................................................................................12
DRUG
INTERACTIONS..................................................................................................14
DOSAGE AND
ADMINISTRATION..............................................................................17
OVERDOSAGE
...............................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
...........................................................19
STORAGE AND
STABILITY.........................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
...........................................19
PART II: SCIENTIFIC
INFORMATION................................................................................21
PHARMACEUTICAL
INFORMATION.........................................................................21
CLINICAL
TRIALS.........................................................................................................22
DETAILED
PHARMACOLOGY................................................