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ACTIVE SUBSTANCE / INN

TRABECTEDIN

Brand name(s): YONDELIS, Trabectedin Accord, TRABECTEDIN, Yondelis
FDA LISTED
EMA LISTED
PRESCRIPTION
REFUSED
AUTHORISED
Sarcoma;Ovarian Neoplasms
NDA207953
ACTIVE SUBSTANCE
Trabectedin
REGULATORS
FDA · EMA
SPONSORS / MAH
NATCO PHARMA LTD, Pharma Mar S.A., JANSSEN PRODS
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
YONDELISNDA207953JANSSEN PRODSPrescription
TRABECTEDINANDA214837NATCO PHARMA LTDNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Trabectedin AccordAccord Healthcare S.L.U.Authorised25/04/2025Sarcoma;Ovarian Neoplasms
YondelisPharma Mar S.A.Authorised17/09/2007Ovarian Neoplasms;Sarcoma
YondelisPharma Mar S.A.RefusedSarcoma

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