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ACTIVE SUBSTANCE / INN

ECULIZUMAB

Brand name(s): Bekemv, SOLIRIS, Epysqli, Soliris
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
Hemoglobinuria, Paroxysmal
BLA125166
ACTIVE SUBSTANCE
Eculizumab
REGULATORS
FDA · EMA
SPONSORS / MAH
ALEXION PHARM, Amgen Technology (Ireland) UC, Alexion Europe SAS
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
SOLIRISBLA125166ALEXION PHARMPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
SolirisAlexion Europe SASAuthorised20/06/2007Hemoglobinuria, Paroxysmal
EpysqliSamsung Bioepis NL B.V.Authorised26/05/2023Hemoglobinuria, Paroxysmal
BekemvAmgen Technology (Ireland) UCAuthorised19/04/2023Hemoglobinuria, Paroxysmal

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