Zefylti (filgrastim)
- Region
- 🇪🇺 EU
- Active substance
- filgrastim
- Company
- CuraTeQ Biologics s.r.o
- Status
- Application withdrawn
- Application
- EMEA/H/C/005888
- ATC
- L03AA02
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇺🇸 Armlupeg Approved · Lupin Ltd
- 🇪🇺 Nylaspeg Authorised · Qilu Pharma Spain S.L.
- 🇪🇺 Filgrastim Hexal Authorised · Hexal AG
- 🇪🇺 Zarzio Authorised · Sandoz GmbH
- 🇪🇺 Cavoley Authorised · CuraTeQ Biologics s.r.o
- 🇪🇺 Neuzafy Opinion · CuraTeQ Biologics (Malta) Limited
- 🇪🇺 Ratiograstim Authorised · Ratiopharm GmbH
- 🇪🇺 Tevagrastim Authorised · Teva GmbH
- 🇪🇺 Ziextenzo Authorised · Sandoz GmbH
- 🇺🇸 Filkri Approved · Accord Biopharma Inc.
- 🇪🇺 Grasustek Authorised · Juta Pharma GmbH
- 🇪🇺 Nivestim Authorised · Pfizer Europe MA EEIG
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.