ACTIVE SUBSTANCE / INN

FILGRASTIM

Brand name(s): Zarzio, Biograstim, Tevagrastim, Accofil, Filgrastim ratiopharm, NEUPOGEN, Nivestim, Filgrastim Hexal, Ratiograstim, Zefylti, Grastofil
FDA LISTED
EMA LISTED
PRESCRIPTION
APPLICATION WITHDRAWN
WITHDRAWN
Neutropenia;Hematopoietic Stem Cell Transplantation;Cancer
BLA103353
ACTIVE SUBSTANCE
Filgrastim
REGULATORS
FDA · EMA
SPONSORS / MAH
AMGEN, AbZ-Pharma GmbH, Hexal AG
TOTAL APPLICATIONS
12
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
NEUPOGENBLA103353AMGENPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
NivestimPfizer Europe MA EEIGAuthorised07/06/2010Hematopoietic Stem Cell Transplantation;Cancer
AccofilAccord Healthcare S.L.U.Authorised17/09/2014
ZefyltiCuraTeQ Biologics s.r.oAuthorised12/02/2025Neutropenia;Hematopoietic Stem Cell Transplantation;Cancer
GrastofilAccord Healthcare S.L.U.Withdrawn18/10/2013
Filgrastim HexalHexal AGAuthorised06/02/2009Hematopoietic Stem Cell Transplantation;Cancer
ZarzioSandoz GmbHAuthorised06/02/2009Hematopoietic Stem Cell Transplantation;Cancer
TevagrastimTeva GmbHAuthorised15/09/2008Hematopoietic Stem Cell Transplantation;Cancer
RatiograstimRatiopharm GmbHAuthorised15/09/2008Hematopoietic Stem Cell Transplantation;Cancer
ZefyltiCuraTeQ Biologics s.r.oApplication withdrawn
BiograstimAbZ-Pharma GmbHWithdrawn15/09/2008Hematopoietic Stem Cell Transplantation;Cancer

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