ACTIVE SUBSTANCE / INN

EPOETIN ALFA

Brand name(s): EPOGEN/PROCRIT, Epostim, Binocrit, Abseamed, Epoetin Alfa Hexal
FDA LISTED
EMA LISTED
PRESCRIPTION
APPLICATION WITHDRAWN
AUTHORISED
Anemia
BLA103234
ACTIVE SUBSTANCE
Epoetin Alfa
REGULATORS
FDA · EMA
SPONSORS / MAH
AMGEN, Reliance GeneMedix Plc, Hexal AG
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
EPOGEN/PROCRITBLA103234AMGENPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Epoetin Alfa HexalHexal AGAuthorised27/08/2007Anemia;Kidney Failure, Chronic;Blood Transfusion, Autologous;Myelodysplastic Syn…
BinocritSandoz GmbHAuthorised28/08/2007Anemia;Kidney Failure, Chronic;Blood Transfusion, Autologous;Myelodysplastic Syn…
AbseamedMedice Arzneimittel Pütter GmbH Co. KGAuthorised27/08/2007Anemia;Kidney Failure, Chronic;Blood Transfusion, Autologous;Myelodysplastic Syn…
EpostimReliance GeneMedix PlcApplication withdrawnAnemia

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