Overview

The marketing authorisation for Udenyca has been withdrawn at the request of the marketing-authorisation holder.

Udenyca : EPAR - Medicine overview

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Udenyca : EPAR - Risk-management-plan summary

Product information

Udenyca : EPAR - Product information

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Latest procedure affecting product information: PSUSA/00002326/201901

22/11/2019

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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

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italiano (IT) (574.99 KB - PDF)
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português (PT) (574.96 KB - PDF)
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slovenščina (SL) (597.97 KB - PDF)
Suomi (FI) (574.78 KB - PDF)
svenska (SV) (575.02 KB - PDF)

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

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

Udenyca : EPAR - Public assessment report

CHMP summary of positive opinion for Udenyca

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