Ristempa

pegfilgrastim

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The marketing authorisation for Ristempa has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Ristempa : EPAR - Summary for the public BG = bălgarski 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public ES = español 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public CS = čeština 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public DA = dansk 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public DE = Deutsch 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public ET = eesti keel 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public EL = elliniká 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public FR = français 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public IT = italiano 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public LV = latviešu valoda 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public LT = lietuvių kalba 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public HU = magyar 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public MT = Malti 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public NL = Nederlands 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public PL = polski 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public PT = português 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public RO = română 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public SK = slovenčina 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public SL = slovenščina 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public FI = suomi 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public SV = svenska 2015-04-16 2018-03-07
Ristempa : EPAR - Summary for the public HR = Hrvatski 2015-04-16 2018-03-07
Name Language First published Last updated
Ristempa : EPAR - Risk-management-plan summary (English only) 2015-04-15 2018-03-07

This EPAR was last updated on 07/03/2018 .

Authorisation details

Product details

Product details for Ristempa
NameRistempa
Agency product numberEMEA/H/C/003910
Active substance

pegfilgrastim

International non-proprietary name (INN) or common name

pegfilgrastim

Therapeutic area Neutropenia
Anatomical therapeutic chemical (ATC) code L03AA13
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Ristempa
Marketing-authorisation holder

Amgen Europe B.V.

Revision3
Date of issue of marketing authorisation valid throughout the European Union13/04/2015

Contact address:

Amgen Europe B.V.
Minervum 7061
4817ZK Breda
The Netherlands

Product information

Product information

29/09/2017  Ristempa -EMEA/H/C/003910 -IAIN/0010

Name Language First published Last updated
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - Product Information EN = English 2015-04-16 2018-03-07

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
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07
Ristempa : EPAR - All Authorised presentations EN = English 2015-04-16 2018-03-07

Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Ristempa : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2015-11-17 2018-03-07

Initial marketing-authorisation documents

Name Language First published Last updated
Ristempa : EPAR - Public assessment report EN = English 2015-04-16 2018-03-07
CHMP summary of positive opinion for Ristempa EN = English 2015-02-27 2018-03-07

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Ristempa