Overview

The marketing authorisation for Biograstim has been withdrawn at the request of the marketing-authorisation holder.

Biograstim : EPAR - Summary for the public

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Product information

Biograstim : EPAR - Product Information

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Latest procedure affecting product information: IB/0029

23/09/2015

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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

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español (ES) (467.5 KB - PDF)
čeština (CS) (584.07 KB - PDF)
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română (RO) (533.54 KB - PDF)
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slovenščina (SL) (479.4 KB - PDF)
Suomi (FI) (466.59 KB - PDF)
svenska (SV) (466.49 KB - PDF)

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 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.

Authorisation details

EMA product number
EMEA/H/C/000826

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.

Marketing authorisation holder
AbZ-Pharma GmbH

Graf -Arco-Strase 3
99079 Ulm
Germany

Marketing authorisation issued
15/09/2008
Revision
8

Assessment history

Biograstim : EPAR - Procedural steps taken and scientific information after authorisation

Biograstim : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Biograstim

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