Ratiograstim (filgrastim)
- Region
- 🇪🇺 EU
- Active substance
- filgrastim
- Company
- Ratiopharm GmbH
- Status
- Authorised
- Therapeutic area
- Hematopoietic Stem Cell Transplantation; Cancer
- CHMP opinion
- Thu 24 Jul 2008
- EU approval
- Mon 15 Sep 2008
- Designations
- Biosimilar
- Application
- EMEA/H/C/000825
- ATC
- L03AA02
- Official record
- www.ema.europa.eu
Indication
Ratiograstim is indicated for the 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 for the 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. Ratiograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC). In patients, children or 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 Ratiograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Ratiograstim is indicated for the 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 options to manage neutropenia are inappropriate.
Regulatory milestones
No milestones recorded in the last year.
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