CERDELGA CAPSULE

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

ELIGLUSTAT (ELIGLUSTAT TARTRATE)

Tilgjengelig fra:

SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC

ATC-kode:

A16AX10

INN (International Name):

ELIGLUSTAT

Dosering :

84MG

Legemiddelform:

CAPSULE

Sammensetning:

ELIGLUSTAT (ELIGLUSTAT TARTRATE) 84MG

Administreringsrute:

ORAL

Enheter i pakken:

14/56

Resept typen:

Prescription

Terapeutisk område:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2017-04-21

Preparatomtale

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
.........................................................