Basic Information
Nyvepria
Regulatory Information
EMEA/H/C/005085
November 18, 2020
September 17, 2020
7
August 19, 2024
Company Information
Belgium
Boulevard de la Plaine 17 1050 Bruxelles
Pfizer Europe MA EEIG
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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).
Overview Summary
Nyvepria 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 chemotherapy 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 due to an infection). Nyvepria is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia). Nyvepria is a ‘biosimilar medicine’. This means that Nyvepria is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Nyvepria is Neulasta. Nyvepria contains the active substance pegfilgrastim.