Ristempa
pegfilgrastim
Table of contents
Overview
The marketing authorisation for Ristempa has been withdrawn at the request of the marketing authorisation holder.
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List item
Ristempa : EPAR - Summary for the public (PDF/1.39 MB)
First published: 16/04/2015
Last updated: 07/03/2018 -
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List item
Ristempa : EPAR - Risk-management-plan summary (PDF/1.4 MB)
First published: 15/04/2015
Last updated: 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 |
13/04/2015
|
| Contact address |
Minervum 7061
4817 ZK Breda The Netherlands |
Product information
29/09/2017 Ristempa - EMEA/H/C/003910 - IAIN/0010
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).
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)