Ristempa

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pegfilgrastim

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Ristempa has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 07/03/2018

Authorisation details

Product details
Name
Ristempa
Agency product number
EMEA/H/C/003910
Active substance
pegfilgrastim
International non-proprietary name (INN) or common name
pegfilgrastim
Therapeutic area (MeSH)
Neutropenia
Anatomical therapeutic chemical (ATC) code
L03AA13
Additional monitoring

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

Publication details
Marketing-authorisation holder
Amgen Europe B.V.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
12/04/2015
Contact address
Minervum 7061
4817 ZK Breda
The Netherlands

Product information

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

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.

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

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