CERDELGA CAPSULE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ELIGLUSTAT (ELIGLUSTAT TARTRATE)

Διαθέσιμο από:

SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC

Φαρμακολογική κατηγορία (ATC):

A16AX10

INN (Διεθνής Όνομα):

ELIGLUSTAT

Δοσολογία:

84MG

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

ELIGLUSTAT (ELIGLUSTAT TARTRATE) 84MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

14/56

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2017-04-21

Αρχείο Π.Χ.Π.

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