Grastofil

Withdrawn

This medicine's authorisation has been withdrawn

filgrastim

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European public assessment report (EPAR) for Grastofil will be updated to indicate that the marketing authorisation is no longer valid.

Grastofil : EPAR - Medicine overview

Reference Number: EMA/569200/2018

Grastofil : EPAR - Risk-management-plan summary

Product information

Grastofil : EPAR - Product Information

Grastofil : EPAR - All Authorised presentations

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

Immunostimulants

Therapeutic 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.

Authorisation details

• EMA product number:
  EMEA/H/C/002150
• 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:
  Accord Healthcare S.L.U.

  Edificio Este Planta 6a; World Trade Center; Moll De Barcelona S/n; 08039 Barcelona; SPAIN

• Opinion adopted:
  25/07/2003
• Marketing authorisation issued:
  18/10/2013
• Withdrawal of marketing authorisation:
  13/01/2025
• Revision:
  14

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Grastofil : EPAR - Public assessment report

Adopted Reference Number: EMEA/CHMP/303037/2013

CHMP summary of positive opinion for Grastofil

Adopted Reference Number: EMA/CHMP/304525/2013