EZETIMIBE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

EZETIMIBE

제공처:

LABORATOIRE RIVA INC.

ATC 코드:

C10AX09

INN (국제 이름):

EZETIMIBE

복용량:

10MG

약제 형태:

TABLET

구성:

EZETIMIBE 10MG

관리 경로:

ORAL

패키지 단위:

30/100

처방전 유형:

Prescription

치료 영역:

CHOLESTEROL ABSORPTION INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0149164001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2018-07-11

제품 특성 요약

_Product Monograph – EZETIMIBE _
_Page 1 of 30 _
PRODUCT MONOGRAPH
PR EZETIMIBE
Ezetimibe Tablets, USP
10 mg
Cholesterol Absorption Inhibitor
www.labriva.com
SUBMISSION CONTROL NO:
235246
Canada, J7C 3V4
Blainville, Quebec
660 Boul. Industriel
LABORATOIRE RIVA INC.
February 6, 2020
DATE OF REVISION:
_Product Monograph – EZETIMIBE _
_Page 2 of 30 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
.......................................................................................
3
INFORMATION SUMMARY PRODUCT INFORMATION
.......................................... 3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
13
OVERDOSAGE
...............................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 14
STORAGE AND STABILITY
.........................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 16
PART II: SCIENTIFIC INFORMATION
...............................................................................
17
PHARMACEUTICAL INFORMATION
.........................................................................
17
CLINICAL TRIALS
.........................................................................................................
19
TOXICOLOGY
..........