SANDOZ ALISKIREN TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
01-09-2016
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유효 성분:
ALISKIREN (ALISKIREN FUMARATE)
제공처:
SANDOZ CANADA INCORPORATED
ATC 코드:
C09XA02
INN (국제 이름):
ALISKIREN
복용량:
300MG
약제 형태:
TABLET
구성:
ALISKIREN (ALISKIREN FUMARATE) 300MG
관리 경로:
ORAL
패키지 단위:
28
처방전 유형:
Prescription
치료 영역:
RENIN INHIBITORS
제품 요약:
Active ingredient group (AIG) number: 0152352002; AHFS:
승인 상태:
CANCELLED PRE MARKET
승인 날짜:
2017-12-06
제품 특성 요약
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_Sandoz Aliskiren Page 1 of 28_
PRODUCT MONOGRAPH
PR
SANDOZ ALISKIREN
aliskiren (as aliskiren fumarate)
Tablets, 150 and 300 mg
Renin inhibitor
Sandoz Canada Inc.
145 Jules-Léger
Boucherville (QC)
J4B 7K8
Date of Revision: August 31, 2016
Submission Control No: 197205
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_Sandoz Aliskiren Page 2 of 28_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..........................................................
3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
.................................................................................................
3
WARNINGS AND PRECAUTIONS
...............................................................................
4
ADVERSE REACTIONS
.................................................................................................
8
DRUG INTERACTIONS
................................................................................................
12
DOSAGE AND ADMINISTRATION
...........................................................................
15
OVERDOSAGE
...............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 16
STORAGE AND STABILITY
.......................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 19
PART II: SCIENTIFIC INFORMATION
...............................................................................
20
PHARMACEUTICAL INFORMATION
.....................................................................
20
CLINICAL TRIALS
.......................................................................................................
21
DETAILED PHARMACOLOGY
........................................................................
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