Filgrastim ratiopharm

Withdrawn

This medicine's authorisation has been withdrawn

filgrastim

Overview

The marketing authorisation for Filgrastim ratiopharm has been withdrawn at the request of the marketing authorisation holder.

Filgrastim ratiopharm : EPAR - Summary for the public

Product information

Filgrastim ratiopharm : EPAR - Product Information

Latest procedure affecting product information: IB/0001/G

20/04/2011

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

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).

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):
  • Neutropenia
  • 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
• 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