Udenyca is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever).
Udenyca is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in large numbers of abnormal blood cells are produced, , which can develop into leukaemia).
Udenyca is a ‘biosimilar medicine’. This means that Udenyca is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Udenyca is Neulasta.
Udenyca : EPAR - Medicine overview (PDF/68.14 KB)
First published: 23/10/2018
Udenyca : EPAR - Risk-management-plan summary (PDF/94.71 KB)
First published: 29/10/2018
|Agency product number||
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ERA Consulting GmbH
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22/11/2019 Udenyca - EMEA/H/C/004413 - PSUSA/00002326/201901
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Colony stimulating factors
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).