Udenyca

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pegfilgrastim

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Udenyca has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 15/02/2021

Authorisation details

Product details
Name
Udenyca
Agency product number
EMEA/H/C/004413
Active substance
pegfilgrastim
International non-proprietary name (INN) or common name
pegfilgrastim
Therapeutic area (MeSH)
Neutropenia
Anatomical therapeutic chemical (ATC) code
L03AA13
Additional monitoringAdditional 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.

BiosimilarBiosimilar

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.

Publication details
Marketing-authorisation holder
ERA Consulting GmbH
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
21/09/2018
Contact address
Lange Strasse 70
29664 Walsrode
Germany

Product information

22/11/2019 Udenyca - EMEA/H/C/004413 - PSUSA/00002326/201901

Contents

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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).

Assessment history

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