MINT-FENOFIBRATE E TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
23-06-2017
이 제품에 대한 일부 문서는 현재 사용할 수 없습니다. 고객 서비스에 요청을 보내면 가능한 빨리 알려 드리겠습니다.
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유효 성분:
FENOFIBRATE
제공처:
MINT PHARMACEUTICALS INC
ATC 코드:
C10AB05
INN (International Name):
FENOFIBRATE
복용량:
145MG
약제 형태:
TABLET
구성:
FENOFIBRATE 145MG
관리 경로:
ORAL
패키지 단위:
90
처방전 유형:
Prescription
치료 영역:
FRIBIC ACID DERIVATIVES
제품 요약:
Active ingredient group (AIG) number: 0118895006; AHFS:
승인 상태:
CANCELLED POST MARKET
승인 날짜:
2020-04-28
제품 특성 요약
PRODUCT MONOGRAPH
Pr
MINT-FENOFIBRATE E
fenofibrate
film-coated tablets (145 mg)
USP
LIPID METABOLISM REGU
LATOR
Mint Pharmaceuticals Inc.
Date of Preparation:
1093 Meyerside Dr., Unit #1
JUNE 15, 2017
Mississauga, Ontario
L5T 1J6
Submission Control No: 186636
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................. 3
SUMMARY PRODUCT
INFORMATION.........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
....................................................................................................
4
WARNINGS AND PRECAUTIONS
..................................................................................
4
ADVERSE REACTIONS
..................................................................................................
10
DRUG INTERACTIONS
..................................................................................................
14
DOSAGE AND ADMINISTRATION
..............................................................................
18
OVERDOSAGE
.................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 19
STORAGE AND STABILITY
..........................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 21
PART II: SCIENTIFIC INFORMATION
........................................................................
23
PHARMACEUTICAL INFORMATION
..........................................................................
23
CLINICAL TRIALS
..........................................................................................................
24
DETAILED PHARMACOLOGY
.....................................................................................
29
TO
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