An overview of Xgeva and why it is authorised in the EU
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/82.08 KB)
First published: 15/08/2011
Last updated: 24/05/2018
Xgeva: EPAR - Risk-management plan summary (PDF/84.44 KB)
First published: 05/06/2019
|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||
11/04/2019 Xgeva - EMEA/H/C/002173 - II/0068
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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