LIVMARLI SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

MARALIXIBAT (MARALIXIBAT CHLORIDE)

Tersedia dari:

MIRUM PHARMACEUTICALS, INC.

Kode ATC:

A05AX04

INN (Nama Internasional):

MARALIXIMAB CHLORIDE

Dosis:

9.5MG

Bentuk farmasi:

SOLUTION

Komposisi:

MARALIXIBAT (MARALIXIBAT CHLORIDE) 9.5MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2023-07-21

Karakteristik produk

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