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news.The Committee for Medicinal Products for Human Use or CHMP has recommended marketing authorization of ratiopharm's Filgrastim and Teva's Tevagrastim, solutions for injection or infusion in a pre-filled syringe intended for the treatment of neutropenia.
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Filgrastim and Tevagrastim are 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.
Biograstim is also indicated for the treatment of persistent neutropenia (ANC less than or equal to 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.