EMA — authorised 18 October 2013
- Application: EMEA/H/C/002150
- Marketing authorisation holder: Accord Healthcare S.L.U.
- Local brand name: Grastofil
- Indication: Grastofil 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 Grastofil are similar in adults and children receiving cytotoxic chemotherapy. Grastofil is indicat
- Pathway: biosimilar
- Status: withdrawn