Biograstim

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filgrastim

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Biograstim has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 19/01/2017

Authorisation details

Product details
Name
Biograstim
Agency product number
EMEA/H/C/000826
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
Biosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
AbZ-Pharma GmbH
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
15/09/2008
Contact address
Graf -Arco-Strase 3
99079 Ulm
Germany

Product information

23/09/2015 Biograstim - EMEA/H/C/000826 - IB/0029

Contents

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Pharmacotherapeutic group

Colony stimulating factors

Therapeutic 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

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