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ACTIVE SUBSTANCE / INN

ODEVIXIBAT

Brand name(s): Kayfanda, Bylvay, BYLVAY
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
Cholestasis, Intrahepatic
NDA215498
ACTIVE SUBSTANCE
Odevixibat
REGULATORS
FDA · EMA
SPONSORS / MAH
IPSEN, Ipsen Pharma
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
BYLVAYNDA215498IPSENPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
KayfandaIpsen PharmaAuthorised19/09/2024Pruritus;Alagille Syndrome
BylvayIpsen PharmaAuthorised16/07/2021Cholestasis, Intrahepatic

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