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ACTIVE SUBSTANCE / INN

DINUTUXIMAB

Brand name(s): Unituxin, UNITUXIN
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
BLA125516
Neuroblastoma
ACTIVE SUBSTANCE
Dinutuximab
REGULATORS
FDA · EMA
SPONSORS / MAH
United Therapeutics Europe Ltd, UNITED THERAP
TOTAL APPLICATIONS
2
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
UNITUXINBLA125516UNITED THERAPPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
UnituxinUnited Therapeutics Europe LtdWithdrawn14/08/2015Neuroblastoma

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