Q-PRAVASTATIN TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
31-05-2013
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유효 성분:
PRAVASTATIN SODIUM
제공처:
QD PHARMACEUTICALS ULC
ATC 코드:
C10AA03
INN (International Name):
PRAVASTATIN
복용량:
10MG
약제 형태:
TABLET
구성:
PRAVASTATIN SODIUM 10MG
관리 경로:
ORAL
패키지 단위:
30/100
처방전 유형:
Prescription
치료 영역:
HMG-COA REDUCTASE INHIBITORS
제품 요약:
Active ingredient group (AIG) number: 0122563001; AHFS:
승인 상태:
CANCELLED PRE MARKET
승인 날짜:
2015-08-21
제품 특성 요약
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PRODUCT MONOGRAPH
PR
Q-PRAVASTATIN
pravastatin sodium tablets
10 mg, 20 mg and 40 mg
USP
Lipid Metabolism Regulator
QD Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control Number: 164225
Date of Revision: May 31, 2013
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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 ............................................................................
24
PHARMACEUTICAL INFORMATION
.........................................................................
24
CLINICAL TRIALS
.........................................................................................................
25
DETAILED PHARMACOLOGY
....................................................................................
32
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