Overview
The marketing authorisation for Biograstim has been withdrawn at the request of the marketing-authorisation holder.
Biograstim : EPAR - Summary for the public
Product information
Biograstim : EPAR - Product Information
Latest procedure affecting product information: IB/0029
23/09/2015
This medicine’s product information is available in all official EU languages.
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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).
Biograstim : EPAR - All Authorised presentations
Product details
- Name of medicine
- Biograstim
- Active substance
- filgrastim
- International non-proprietary name (INN) or common name
- filgrastim
- Therapeutic area (MeSH)
- Neutropenia
- Hematopoietic Stem Cell Transplantation
- Cancer
- Anatomical therapeutic chemical (ATC) code
- L03AA02
Pharmacotherapeutic group
Colony stimulating factorsTherapeutic indication
Biograstim 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.
Biograstim 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 Biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Biograstim 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.
Assessment history
Biograstim : EPAR - Procedural steps taken and scientific information after authorisation