Udenyca

Withdrawn

This medicine's authorisation has been withdrawn

pegfilgrastim

Overview

On 4 February 2021, the European Commission withdrew the marketing authorisation for Udenyca (pegfilgrastim) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, ERA Consulting GmbH, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Udenyca was granted marketing authorisation in the EU on 21 September 2018 for treatment of neutropenia. The marketing authorisation was initially valid for a 5-year period. Udenyca is a biosimilar of Neulasta, which is authorised in the EU to treat neutropenia. 

The European Public Assessment Report (EPAR) for Udenyca is updated to indicate that the marketing authorisation is no longer valid.

Udenyca : EPAR - Medicine overview

Reference Number: EMA/518623/2018

Udenyca : EPAR - Risk-management-plan summary

Product information

Udenyca : EPAR - Product information

Udenyca : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Udenyca
• Active substance:
  pegfilgrastim
• International non-proprietary name (INN) or common name:
  pegfilgrastim
• Anatomical therapeutic chemical (ATC) code:
  L03AA13

Pharmacotherapeutic group

• Immunostimulants
• Colony stimulating factors

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/004413
• Biosimilar:

  This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

• Marketing authorisation holder:
  ERA Consulting GmbH

  Lange Strasse 70; 29664 Walsrode; Germany

• Opinion adopted:
  25/07/2018
• Marketing authorisation issued:
  21/09/2018
• Withdrawal of marketing authorisation:
  04/02/2021
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

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

Udenyca-H-C-4413-PSUSA-00002326-201901 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/562284/2019

Initial marketing authorisation documents

Udenyca : EPAR - Public assessment report

AdoptedReference Number: EMA/552721/2018

CHMP summary of positive opinion for Udenyca

AdoptedReference Number: EMA/490650/2018