MYLAN-SIMVASTATIN TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
31-07-2019
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유효 성분:
SIMVASTATIN
제공처:
MYLAN PHARMACEUTICALS ULC
ATC 코드:
C10AA01
INN (International Name):
SIMVASTATIN
복용량:
10MG
약제 형태:
TABLET
구성:
SIMVASTATIN 10MG
관리 경로:
ORAL
패키지 단위:
30/100
처방전 유형:
Prescription
치료 영역:
HMG-COA REDUCTASE INHIBITORS
제품 요약:
Active ingredient group (AIG) number: 0122415004; AHFS:
승인 상태:
CANCELLED POST MARKET
승인 날짜:
2019-09-17
제품 특성 요약
PRODUCT MONOGRAPH
PR
MYLAN-SIMVASTATIN
(Simvastatin Tablets)
5 mg, 10 mg, 20 mg, 40 mg and 80 mg
USP
Lipid Metabolism Regulator
Mylan Pharmaceuticals ULC
DATE OF REVISION: July 31, 2019
85 Advance Road
Etobicoke, ON
Canada
M8Z 2S6
Submission Number: 230095
_ _
_Product Monograph –Mylan_-_Simvastatin _
_Page 2 of 50 _
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
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
20
OVERDOSAGE
...............................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 22
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
.........................................................................................................
27
DETAILED PHARMACOLOGY
...................................
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