Ryzneuta (efbemalenograstim alfa)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- efbemalenograstim alfa
- Company
- Fisiopharma S.r.l.
- Status
- Authorised
- CHMP opinion
- Wed 25 Jan 2023
- EU approval
- Thu 21 Mar 2024
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005828
- ATC
- L03AA18
- Official record
- www.ema.europa.eu
Indication
Ryzneuta is indicated for the 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.
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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.