Cegfila (previously Pegfilgrastim Mundipharma) (pegfilgrastim)
Biosimilar
- Region
- 🇪🇺 EU
- Active substance
- pegfilgrastim
- Company
- Mundipharma Corporation (Ireland) Limited
- Status
- Authorised
- CHMP opinion
- Thu 17 Oct 2019
- EU approval
- Thu 19 Dec 2019
- Designations
- Biosimilar
- Application
- EMEA/H/C/005312
- 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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- 🇺🇸 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.