LIVMARLI SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Osta se nyt

Valmisteyhteenveto Valmisteyhteenveto (SPC)
21-07-2023

Aktiivinen ainesosa:

MARALIXIBAT (MARALIXIBAT CHLORIDE)

Saatavilla:

MIRUM PHARMACEUTICALS, INC.

ATC-koodi:

A05AX04

INN (Kansainvälinen yleisnimi):

MARALIXIMAB CHLORIDE

Annos:

9.5MG

Lääkemuoto:

SOLUTION

Koostumus:

MARALIXIBAT (MARALIXIBAT CHLORIDE) 9.5MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2023-07-21

Valmisteyhteenveto

                                _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
.................................................................................................
                                
                                Lue koko asiakirja
                                
                            

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Valmisteyhteenveto Valmisteyhteenveto ranska 21-07-2023

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