Udenyca

Withdrawn

This medicine's authorisation has been withdrawn

pegfilgrastim

Overview

The marketing authorisation for Udenyca has been withdrawn at the request of the marketing-authorisation holder.

Udenyca : EPAR - Medicine overview

Reference Number: EMA/518623/2018

Udenyca : EPAR - Risk-management-plan summary

Product information

Udenyca : EPAR - Product information

Latest procedure affecting product information: PSUSA/00002326/201901

22/11/2019

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).

Udenyca : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Udenyca
• Active substance:
  pegfilgrastim
• International non-proprietary name (INN) or common name:
  pegfilgrastim
• Therapeutic area (MeSH):
  Neutropenia
• 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
• 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