Filgrastim ratiopharm

filgrastim

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The marketing authorisation for Filgrastim ratiopharm has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Filgrastim ratiopharm : EPAR - Summary for the public BG = bălgarski 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public ES = español 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public CS = čeština 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public DA = dansk 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public DE = Deutsch 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public ET = eesti keel 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public EL = elliniká 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public EN = English 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public FR = français 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public IT = italiano 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public LV = latviešu valoda 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public LT = lietuvių kalba 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public HU = magyar 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public MT = Malti 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public NL = Nederlands 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public PL = polski 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public PT = português 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public RO = română 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public SK = slovenčina 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public SL = slovenščina 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public FI = suomi 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Summary for the public SV = svenska 30/09/2008 20/07/2011

This EPAR was last updated on 20/07/2011 .

More detail is available in the summary of product characteristics

Authorisation details

Product details

Product details for Filgrastim ratiopharm
NameFilgrastim ratiopharm
Agency product numberEMEA/H/C/000824
Active substance

filgrastim

International non-proprietary name (INN) or common name

filgrastim

Therapeutic area NeutropeniaHematopoietic Stem Cell TransplantationCancer
Anatomical therapeutic chemical (ATC) code L03AA02
Biosimilar

A biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorised (the ‘biological reference medicine’). The active substance of a biosimilar medicine similar to the one of the biological reference medicine. Biosimilar and biological reference medicines are used in general at the same dose to treat the same disease.

Publication details

Publication details for Filgrastim ratiopharm
Marketing-authorisation holder

Ratiopharm GmbH

Revision1
Date of issue of marketing authorisation valid throughout the European Union15/09/2008

Contact address:

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

Product information

Product information

20/04/2011  Filgrastim ratiopharm -EMEA/H/C/000824 -IB/0001/G

Name Language First published Last updated
Filgrastim ratiopharm : EPAR - Product Information BG = bălgarski 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information ES = español 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information CS = čeština 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information DA = dansk 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information DE = Deutsch 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information ET = eesti keel 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information EL = elliniká 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information EN = English 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information FR = français 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information IT = italiano 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information LV = latviešu valoda 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information LT = lietuvių kalba 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information HU = magyar 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information MT = Malti 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information NL = Nederlands 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information PL = polski 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information PT = português 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information RO = română 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information SK = slovenčina 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information SL = slovenščina 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information FI = suomi 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information SV = svenska 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information IS = Islenska 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - Product Information NO = Norsk 30/09/2008 20/07/2011

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Name Language First published Last updated
Filgrastim ratiopharm : EPAR - All Authorised presentations BG = bălgarski 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations ES = español 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations CS = čeština 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations DA = dansk 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations DE = Deutsch 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations ET = eesti keel 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations EL = elliniká 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations EN = English 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations FR = français 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations IT = italiano 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations LV = latviešu valoda 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations LT = lietuvių kalba 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations HU = magyar 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations MT = Malti 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations NL = Nederlands 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations PL = polski 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations PT = português 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations RO = română 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations SK = slovenčina 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations SL = slovenščina 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations FI = suomi 30/09/2008 20/07/2011
Filgrastim ratiopharm : EPAR - All Authorised presentations SV = svenska 30/09/2008 20/07/2011

Pharmacotherapeutic group

L03 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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Filgrastim ratiopharm : EPAR - Procedural steps taken and scientific information after authorisation (English only) 07/03/2011 20/07/2011

Initial marketing-authorisation documents

Name Language First published Last updated
Filgrastim ratiopharm : EPAR - Public assessment report (English only) 30/09/2008 20/07/2011

Withdrawn

This medicine is now withdrawn from use in the European Union

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