Država: Kanada
Jezik: angleščina
Source: Health Canada
MARALIXIBAT (MARALIXIBAT CHLORIDE)
MIRUM PHARMACEUTICALS, INC.
A05AX04
MARALIXIMAB CHLORIDE
9.5MG
SOLUTION
MARALIXIBAT (MARALIXIBAT CHLORIDE) 9.5MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0164842001; AHFS:
APPROVED
2023-07-21
_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 ................................................................................................. Preberite celoten dokument