Overview
The marketing authorisation for Udenyca has been withdrawn at the request of the marketing-authorisation holder.
Udenyca : EPAR - Medicine overview
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).
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