ACTIVE SUBSTANCE / INN

DARATUMUMAB

Brand name(s): DARZALEX, Darzalex
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
BLA761036
Multiple Myeloma
ACTIVE SUBSTANCE
Daratumumab
REGULATORS
FDA · EMA
SPONSORS / MAH
Janssen-Cilag International N.V., JANSSEN BIOTECH
TOTAL APPLICATIONS
2
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DARZALEXBLA761036JANSSEN BIOTECHPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
DarzalexJanssen-Cilag International N.V.Authorised20/05/2016Multiple Myeloma

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