Livmarli (maralixibat chloride)
- Region
- 🇪🇺 EU
- Active substance
- maralixibat chloride
- Company
- Mirum Pharmaceuticals International B.V.
- Status
- Authorised
- Therapeutic area
- Alagille Syndrome
- CHMP opinion
- Thu 13 Oct 2022
- EU approval
- Fri 09 Dec 2022
- Designations
- Orphan, Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/005857
- ATC
- A05AX04
- Official record
- www.ema.europa.eu
Indication
Livmarli is indicated for the treatment of: Cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older, Progressive familial intrahepatic cholestasis (PFIC) in patients 3 months of age and older. Livmarli tablets is indicated in adults and adolescents 12 years and older for the treatment of: Cholestatic pruritus in patients with Alagille syndrome (ALGS), Progressive familial intrahepatic cholestasis (PFIC).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.