EMA — authorised 21 March 2024
- Application: EMEA/H/C/005828
- Marketing authorisation holder: Evive Biotechnology Ireland Limited
- Local brand name: Ryzneuta
- 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).
- Status: approved
The European Medicines Agency (EMA) has approved Ryzneuta, a medicinal product developed by Evive Biotechnology Ireland Limited, for use in the European Union. Ryzneuta is indicated for reducing the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy, excluding chronic myeloid leukaemia and myelodysplastic syndromes. This approval was granted on 21 March 2024, following a standard marketing authorisation application.