Grastofil
Withdrawn
This medicine's authorisation has been withdrawn
filgrastim
MedicineHumanWithdrawn
French is available via eTranslation, the European Commission's machine translation service.
Translate to French | Important information about machine translation
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 13 January 2025, the European Commission withdrew the marketing authorisation for Grastofil (filgrastim) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Accord Healthcare S.L.U., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Grastofil was granted marketing authorisation in the EU on 18 October 2013 for the treatment of neutropenia. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2018.
Grastofil is an identical product to Neupogen, which is authorised in the EU to treat neutropenia.
The European public assessment report (EPAR) for Grastofil will be updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:N/0039
22/12/2021
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Grastofil
- Active substance
- filgrastim
- International non-proprietary name (INN) or common name
- filgrastim
- Anatomical therapeutic chemical (ATC) code
- L03AA02
Pharmacotherapeutic group
ImmunostimulantsTherapeutic 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 indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).
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 Grastofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Grastofil is 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.
News on Grastofil
Thèmes
This page was last updated on