This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine. If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).
Therapeutic Indication
* Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone\-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. * Mobilisation of peripheral blood progenitor cells (PBPCs). * In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of of ? 0\.5 x 109/l, and a history of severe or recurrent infections, long\-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection\-related events. * Treatment of persistent neutropenia (ANC ? 0\.5 x 109/l), and a history of severe or recurrent infections, long\-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection\-related events. * in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.
Therapeutic Area (MeSH)
ATC Code
L03AA02
ATC Item
N/A
Pharmacotherapeutic Group
Immunostimulants
Active Substance (Summary)
INN / Common Names
EMA Name
Filgrastim Hexal
Medicine Name
Filgrastim Hexal
Aliases
N/ANo risk management plan link.
