Indication
Zefylti is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of Zefylti are similar in adults and children receiving cytotoxic chemotherapy. Zefylti is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Zefylti is indicated to increase neutrophil counts and to reduce the incidence and duration of infection related events.
Zefylti is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
In other countries
The same active substances on other registers, the same brand first.
National listings
The national registers that list this EU medicine.
- ZefyltiCroatiaSame brand
- ZefyltiItaly · Soluzione iniettabile/infusione in siringa pre-riempita · Curateq Biologics (Malta) LimitedSame brand
- Zefylti 30 MU/0,5 ml oplossing voor injectie / infusie in een voorgevulde spuitNetherlands · Oplossing voor injectie of infusie · CuraTeQ Biologics (Malta) LimitedSame brand
- Zefylti 48 MU/0,5 ml oplossing voor injectie / infusie in een voorgevulde spuitNetherlands · Oplossing voor injectie of infusie · CuraTeQ Biologics (Malta) LimitedSame brand
- FilBrazil · Accord Farmacêutica LtdaSame form
- FilgrastimBrazil · Aché Laboratórios Farmacêuticos S.ASame form
- FilgrastineBrazil · Blau Farmacêutica S.A.Same form
- AccofilCroatiaSame form
- NivestimCroatiaSame form
- Neupogen 30 MuSaudi Arabia · RocheSame form
- Neupogen 30 MuSaudi Arabia · Amgen Manufacturing LimitedSame form
- Neupogen 30 MuSaudi Arabia · Amgen Manufacturing LimitedSame form
- Filgrastim Injection 150 μG/0.6MLTaiwan · 注射劑 · 台灣大昌華嘉股份有限公司Same form
- Filgrastim Injection 75 μG/0.3MLTaiwan · 注射劑 · 台灣大昌華嘉股份有限公司Same form
- FILGRASTIM INJECTION M300,300µg/0.7MLTaiwan · 注射劑 · 台灣大昌華嘉股份有限公司Same form
- FilraCanada · 480 MCG / 0.8 ML · Solution · Jamp Pharma CorporationSame substance
- FilraCanada · 300 MCG / 0.5 ML · Solution · Jamp Pharma CorporationSame substance
- GrastofilCanada · 300 MCG / 0.5 ML · Solution · Apotex INCSame substance
- Accofil 12 Mu/0,2 ML Solucion Inyectable y Para Perfusion en Jeringa PrecargadaSpain · 0,12 mg · solución inyectable y para perfusión en jeringa precargada · Accord Healthcare S.L.U.Same substance
- Accofil 30 MU/0,5 ml solucion inyectable y para perfusion en jeringa precargadaSpain · 0,3 mg · solución inyectable y para perfusión en jeringa precargada · Accord Healthcare S.L.U.Same substance
- Accofil 30 MU/0,5 ml solucion inyectable y para perfusion en jeringa precargadaSpain · 0,3 mg · solución inyectable y para perfusión en jeringa precargada · Accord Healthcare S.L.U.Same substance
- AccofilItaly · Soluzione iniettabile o per infusione · Accord Healthcare, S.L.U.Same substance
- GranulokineItaly · soluzione · Amgen Europe B.V.Same substance
- Accofil 30MU/0,5ml solution for injection or infusionNetherlands · Oplossing voor injectie of infusie · Accord Healthcare S.L.U.Same substance
- NeupogenNew Zealand · Inj 300 mcg in 1 ml vialSame substance
- NivestimNew Zealand · Inj 300 mcg per 0.5 ml prefilled syringeSame substance
- NivestimNew Zealand · Inj 480 mcg per 0.5 ml prefilled syringeSame substance
- ACCOFIL 30 MU/0,5 mlRomania · 30MU/0,5 ml · sol. inj./perf. in seringa preumpluta · Accord Healthcare S.L.U.Same substance
- ACCOFIL 30MU/0,5ml SOL. INJ. SAU PERFUZABILA IN SERINGA PREUMPLUTARomania · 30MU/0,5ml · sol. inj. sau perf. in seringa preumpluta · Accord Healthcare LimitedSame substance
- ACCOFIL 48 MU/0,5 mlRomania · 48MU/0,5 ml · sol. inj./perf. in seringa preumpluta · Accord Healthcare S.L.U.Same substance
- Accofil®Serbia · 48MU/0.5ml · rastvor za injekciju/infuziju u napunjenom injekcionom špricu · Evropa Lek Pharma D.O.O. BeogradSame substance
- Accofil®Serbia · 30MU/0.5ml · rastvor za injekciju/infuziju u napunjenom injekcionom špricu · Evropa Lek Pharma D.O.O. BeogradSame substance
- Accofil®Serbia · 48MU/0.5ml · rastvor za injekciju/infuziju u napunjenom injekcionom špricu · Evropa Lek Pharma D.O.O. BeogradSame substance
- Accofil 30 Solution for Injection or Infusion in A Pre-Filled Syringe 30 Mu/0.5 MLSingapore · 300 mcg/0.5 mL · injection, solution · Accord Healthcare Private LimitedSame substance
- Accofil 48 Solution for Injection or Infusion in A Pre-Filled Syringe 48 Mu/0.5 MLSingapore · 480 mcg/0.5 mL · injection, solution · Accord Healthcare Private LimitedSame substance
- NEUPOGEN PRE-FILLED SYRINGE 30 mu/0.5 mlSingapore · 30 mu/0.5 ml · injection · Amgen Biotechnology Singapore Pte LTDSame substance
- NeupogenUnited States · 300MGC/0.5ML, 480MCG/0.8ML · syringe · AmgenSame substance
- NeupogenUnited States · 300MCG/1ML, 480MCG/1.6ML · vial · AmgenSame substance
- NypoziUnited States · 300MCG/0.5ML, 480MCG/0.8ML · injectable · Tanvex Biopharma USA INCSame substance
Documents
The official texts, at the regulator.
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
Source: European Medicines Agency, EPAR list (imported 10 June 2026).
Licence: EMA content, reuse with acknowledgement · Added 10 Jun 2026
Report an error or request removalCorrections from the holder or the register are welcome.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Active substance
- Filgrastim
- Register
- European Union (EMA)
- Status
- Authorised
- Authorised
- 12 Feb 2025
- Registration
- EMEA/H/C/006400
- Marketing authorisation holder
- CuraTeQ Biologics s.r.o
- ATC code
- L03AA02
- Therapeutic area
- Neutropenia;Hematopoietic Stem Cell Transplantation;Cancer
- Procedure
- EU centralised
- EMA product number
- EMEA/H/C/006400



