LIVMARLI SOLUTION

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

MARALIXIBAT (MARALIXIBAT CHLORIDE)

Fáanlegur frá:

MIRUM PHARMACEUTICALS, INC.

ATC númer:

A05AX04

INN (Alþjóðlegt nafn):

MARALIXIMAB CHLORIDE

Skammtar:

9.5MG

Lyfjaform:

SOLUTION

Samsetning:

MARALIXIBAT (MARALIXIBAT CHLORIDE) 9.5MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2023-07-21

Vara einkenni

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