LIVMARLI SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

MARALIXIBAT (MARALIXIBAT CHLORIDE)

Saadav alates:

MIRUM PHARMACEUTICALS, INC.

ATC kood:

A05AX04

INN (Rahvusvaheline Nimetus):

MARALIXIMAB CHLORIDE

Annus:

9.5MG

Ravimvorm:

SOLUTION

Koostis:

MARALIXIBAT (MARALIXIBAT CHLORIDE) 9.5MG

Manustamisviis:

ORAL

Ühikuid pakis:

15G/50G

Retsepti tüüp:

Prescription

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2023-07-21

Toote omadused

_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
.................................................................................................