Udenyca

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pegfilgrastim

Authorised
This medicine is authorised for use in the European Union.

Overview

Udenyca is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.

It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever).

Udenyca is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in large numbers of abnormal blood cells are produced, , which can develop into leukaemia).

Udenyca is a ‘biosimilar medicine’. This means that Udenyca is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Udenyca is Neulasta.

This EPAR was last updated on 27/07/2018

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 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.

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.

Publication details
Marketing-authorisation holder
ERA Consulting GmbH
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
20/09/2018
Contact address
Lange Strasse 70
29664 Walsrode
Germany

Product information

20/09/2018 Udenyca - EMEA/H/C/004413 - -

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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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