Table of contents
Xgeva is a medicine used to prevent bone complications in adults with advanced cancer that has spread to the bone. These complications include fractures (breaks in the bone), spinal compression (pressure on the spinal cord caused by damage to the surrounding bone), or bone problems requiring radiotherapy (treatment with radiation) or surgery.
Xgeva is also used to treat a type of bone cancer called giant cell tumour of bone in adults and adolescents whose bones have fully developed. It is used in patients who cannot be treated by surgery or in whom surgery is likely to cause complications.
Xgeva contains the active substance denosumab.
Xgeva: EPAR - Medicine overview (PDF/81 KB)
First published: 15/08/2011
Last updated: 05/08/2019
Xgeva: EPAR - Risk-management plan summary (PDF/122.86 KB)
First published: 05/06/2019
Last updated: 07/07/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Amgen Europe B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
21/07/2022 Xgeva - EMEA/H/C/002173 - IB/0081
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.
Drugs for treatment of bone diseases
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).
Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 201823/02/2018
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 201727/01/2017
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 October 201325/10/2013