- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 28 September 2017 the European Commission withdrew the marketing authorisation for Ristempa (pegfilgrastim) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Amgen Europe B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Ristempa was granted marketing authorisation in the EU on 13 April 2015 for the treatment of neutropenia.
Ristempa was a duplicate application to Neulasta, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Neulasta.
The European Public Assessment Report (EPAR) for Ristempa is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
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).
Product details
- Name of medicine
- Ristempa
- Active substance
- pegfilgrastim
- International non-proprietary name (INN) or common name
- pegfilgrastim
- Anatomical therapeutic chemical (ATC) code
- L03AA13
Pharmacotherapeutic group
ImmunostimulantsTherapeutic 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)