Ristempa

Withdrawn

This medicine's authorisation has been withdrawn

pegfilgrastim

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Assessment Report (EPAR) for Ristempa is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Ristempa : EPAR - Summary for the public

Ristempa : EPAR - Risk-management-plan summary

Product information

Ristempa : EPAR - Product Information

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

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)

Authorisation details

• EMA product number:
  EMEA/H/C/003910
• Marketing authorisation holder:
  Amgen Europe B.V.

  Minervum 7061; 4817 ZK Breda; The Netherlands

• Opinion adopted:
  26/02/2015
• Marketing authorisation issued:
  13/04/2015
• Withdrawal of marketing authorisation:
  28/09/2017
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

Ristempa : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Ristempa : EPAR - Public assessment report

AdoptedReference Number: EMA/187414/2015

CHMP summary of positive opinion for Ristempa

AdoptedReference Number: EMA/CHMP/83846/2015