filgrastim - EPARs for authorised medicinal products for human use - Zarzio

FICHA FARMACOLÓGICA de filgrastim. Contiene la Monografía en distintos idiomas (de la Unión Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. JUNIO 02, 2010.-

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EPARs for authorised medicinal products for human use - Zarzio

Active Substance
filgrastim
International Nonproprietary Name or Common Name
filgrastim
Pharmaco-therapeutic Group
Colony stimulating factors
ATC Code
L03AA02

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 (PBPC).

-In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of
-Treatment of persistent neutropenia (ANC

Date of issue of Marketing Authorisation valid throughout the European Union
06 February 2009

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use