Ziextenzo (pegfilgrastim)
Biosimilar
- Region
- 🇪🇺 EU
- Active substance
- pegfilgrastim
- Company
- Sandoz GmbH
- Status
- Authorised
- CHMP opinion
- Thu 20 Sep 2018
- EU approval
- Thu 22 Nov 2018
- Designations
- Biosimilar
- Application
- EMEA/H/C/004802
- ATC
- L03AA13
- Official record
- www.ema.europa.eu
Indication
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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- 🇪🇺 Fulphila Authorised · Biosimilar Collaborations Ireland Limited
- 🇪🇺 Dyrupeg Authorised · CuraTeQ Biologics (Malta) Limited
- 🇪🇺 Pelgraz Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Lonquex Authorised · Teva B.V.
- 🇪🇺 Pelmeg Authorised · Mundipharma Corporation (Ireland) Limited
- 🇪🇺 Cegfila (previously Pegfilgrastim Mundipharma) Authorised · Mundipharma Corporation (Ireland) Limited
- 🇪🇺 Vivlipeg Authorised · Biosimilar Collaborations Ireland Limited
- 🇺🇸 Ennumo Approved · Accord Biopharma Inc.
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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.