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ACTIVE SUBSTANCE / INN

PEGFILGRASTIM

Brand name(s): Pelgraz Paediatric, Pelgraz, Fulphila, Pelmeg, Vivlipeg, Cegfila (previously Pegfilgrastim Mundipharma), Grasustek, Ristempa, Efgratin, Neulasta, Ziextenzo, Nyvepria, Neupopeg, Udenyca, Dyrupeg, NEULASTA, Zioxtenzo, Stimufend, Cavoley
FDA LISTED
EMA LISTED
PRESCRIPTION
APPLICATION WITHDRAWN
WITHDRAWN
BLA125031
Neutropenia;Cancer
ACTIVE SUBSTANCE
Pegfilgrastim
REGULATORS
FDA · EMA
SPONSORS / MAH
AMGEN, Dompé Biotec S.p.A., Gedeon Richter Plc.
TOTAL APPLICATIONS
23
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
NEULASTABLA125031AMGENPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
VivlipegBiosimilar Collaborations Ireland LimitedAuthorised18/08/2025Neutropenia;Febrile Neutropenia;Chemotherapy-Induced Febrile Neutropenia;Cancer
FulphilaBiosimilar Collaborations Ireland LimitedAuthorised20/11/2018—
NyvepriaPfizer Europe MA EEIGAuthorised18/11/2020—
NeulastaAmgen Europe B.V.Authorised22/08/2002Cancer;Neutropenia;Febrile Neutropenia;Chemotherapy-Induced Febrile Neutropenia
GrasustekJuta Pharma GmbHAuthorised20/06/2019—
PelmegMundipharma Corporation (Ireland) LimitedAuthorised20/11/2018—
Cegfila (previously Pegfilgrastim Mundipharma)Mundipharma Corporation (Ireland) LimitedAuthorised19/12/2019—
DyrupegCuraTeQ Biologics s.r.oAuthorised28/03/2025Neutropenia;Cancer
Pelgraz PaediatricAccord Healthcare S.L.U.Application withdrawnNeutropenia;Febrile Neutropenia;Cancer
PelgrazAccord Healthcare S.L.U.Authorised21/09/2018—

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