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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Ristempa has been withdrawn at the request of the marketing authorisation holder.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 monitoringAdditional 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
13/04/2015
Contact address
Minervum 7061
4817 ZK Breda
The Netherlands

Product information

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

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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