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ACTIVE SUBSTANCE / INN

DAROLUTAMIDE

Brand name(s): NUBEQA, Nubeqa
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
Prostatic Neoplasms, Castration-Resistant
NDA212099
ACTIVE SUBSTANCE
Darolutamide
REGULATORS
FDA · EMA
SPONSORS / MAH
BAYER HEALTHCARE, Bayer AG
TOTAL APPLICATIONS
2
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
NUBEQANDA212099BAYER HEALTHCAREPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
NubeqaBayer AGAuthorised27/03/2020Prostatic Neoplasms, Castration-Resistant

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