Udenyca
pegfilgrastim
Table of contents
Overview
The marketing authorisation for Udenyca has been withdrawn at the request of the marketing-authorisation holder.
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List item
Udenyca : EPAR - Medicine overview (PDF/630.11 KB)
First published: 23/10/2018
EMA/518623/2018 -
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List item
Udenyca : EPAR - Risk-management-plan summary (PDF/659.71 KB)
First published: 29/10/2018
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 |
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
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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Immunostimulants
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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).