CERDELGA CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ELIGLUSTAT (ELIGLUSTAT TARTRATE)

제공처:

SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC

ATC 코드:

A16AX10

INN (국제 이름):

ELIGLUSTAT

복용량:

84MG

약제 형태:

CAPSULE

구성:

ELIGLUSTAT (ELIGLUSTAT TARTRATE) 84MG

관리 경로:

ORAL

패키지 단위:

14/56

처방전 유형:

Prescription

치료 영역:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

제품 요약:

Active ingredient group (AIG) number: 0158970001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2017-04-21

제품 특성 요약

CERDELGA (eliglustat capsules)_ _
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_Page 1 of 45_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
CERDELGA™
Eliglustat capsules
84 mg eliglustat (as eliglustat tartrate), for oral administration
Various Alimentary Tract and Metabolism Product
Sanofi Genzyme, a division of sanofi-aventis Canada Inc.
1755 Steeles Avenue WestToronto, ON M2R 3T4
Date of Initial Authorization:
APR 21, 2017
Date of Revision:
NOV 29, 2023
Submission Control Number: 275984
RECENT MAJOR LABEL CHANGES
Not Applicable
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics
.................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
.........................................................................................................
9
4.5
Missed Dose
............................................................................................................
9
5
OVERDOSAGE
.........................................................