LIVMARLI SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

MARALIXIBAT (MARALIXIBAT CHLORIDE)

Διαθέσιμο από:

MIRUM PHARMACEUTICALS, INC.

Φαρμακολογική κατηγορία (ATC):

A05AX04

INN (Διεθνής Όνομα):

MARALIXIMAB CHLORIDE

Δοσολογία:

9.5MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

MARALIXIBAT (MARALIXIBAT CHLORIDE) 9.5MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0164842001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2023-07-21

Αρχείο Π.Χ.Π.

_Product Monograph _
_July 2023 _
_LIVMARLI (maralixibat oral solution) _
_Page 1 of 27_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
LIVMARLI
®
Maralixibat oral solution
solution, 9.5 mg/mL maralixibat (as maralixibat chloride), oral
Ileal bile acid transporter inhibitor
Mirum Pharmaceuticals, Inc.
950 Tower Lane, Suite 1050
Foster City, CA 94404
United States of America
Date of Initial Authorization:
JUL 21, 2023
Submission Control Number: 271030
_ _
_Product Monograph _
_July 2023 _
_LIVMARLI (maralixibat oral solution) _
_Page 2 of 27_
RECENT MAJOR LABEL CHANGES
None
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
......................................................................................................
2
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
..........................................................................................
4
4.1
Dosing Considerations
.........................................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
.................................................................... 5
4.3
Administration
.................................................................................................