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ACTIVE SUBSTANCE / INN

IVOSIDENIB

Brand name(s): Tidhesco, Tibsovo, TIBSOVO
FDA LISTED
EMA LISTED
PRESCRIPTION
APPLICATION WITHDRAWN
AUTHORISED
Leukemia, Myeloid, Acute
NDA211192
ACTIVE SUBSTANCE
Ivosidenib
REGULATORS
FDA · EMA
SPONSORS / MAH
SERVIER, Agios Netherlands B.V., Les Laboratoires Servier
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
TIBSOVONDA211192SERVIERPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
TibsovoLes Laboratoires ServierAuthorised04/05/2023Leukemia, Myeloid, Acute;Cholangiocarcinoma
TidhescoLes Laboratoires ServierApplication withdrawnLeukemia, Myeloid, Acute
TibsovoAgios Netherlands B.V.Application withdrawnLeukemia, Myeloid, Acute

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