Filgrastim ratiopharm

Withdrawn

This medicine's authorisation has been withdrawn

filgrastim

Overview

On 15 September 2009 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Filgrastim ratiopharm (filgrastim) for the treatment of neutropenia. Filgrastim ratiopharm was a biological medicinal product and a biosimilar of the product Neupogen. The marketing authorisation holder (MAH) for Filgrastim ratiopharm was ratiopharm GmbH. 

The European Commission was notified by a letter dated 24 March 2011 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Filgrastim ratiopharm. Filgrastim ratiopharm was not marketed in any EU country. 

On 20 April 2011 the European Commission issued a decision to withdraw the marketing authorisation for Filgrastim ratiopharm. 

Pursuant to this decision the European Public Assessment Report for Filgrastim ratiopharm is updated to reflect that the marketing authorisation is no longer valid.

Filgrastim ratiopharm : EPAR - Summary for the public

Product information

Filgrastim ratiopharm : EPAR - Product Information

Filgrastim ratiopharm : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Filgrastim ratiopharm
• Active substance:
  filgrastim
• International non-proprietary name (INN) or common name:
  filgrastim
• Therapeutic area (MeSH):
  • Hematopoietic Stem Cell Transplantation
  • Cancer
• Anatomical therapeutic chemical (ATC) code:
  L03AA02

Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Filgrastim ratiopharm 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.

Filgrastim ratiopharm 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 Filgrastim ratiopharm is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.

Filgrastim ratiopharm 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/000824
• 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:
  Ratiopharm GmbH

  ratiopharm GmbH; Graf-Arco-Str. 3; D-89079 Ulm; Germany

• Marketing authorisation issued:
  15/09/2008
• Withdrawal of marketing authorisation:
  20/04/2011
• Revision:
  1

Assessment history

Changes since initial authorisation of medicine

Filgrastim ratiopharm : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Filgrastim ratiopharm : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Filgrastim ratiopharm

Reference Number: EMEA/CHMP/67399/2008