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Zarzio (filgrastim)

Biosimilar
Region
🇪🇺 EU
Active substance
filgrastim
Company
Sandoz GmbH
Status
Authorised
Therapeutic area
Hematopoietic Stem Cell Transplantation; Cancer
EU approval
Fri 06 Feb 2009
Designations
Biosimilar
Application
EMEA/H/C/000917
ATC
L03AA02
Official record
www.ema.europa.eu

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 ?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 ? 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.