Xgeva

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denosumab

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 05/08/2019

Authorisation details

Product details
Name
Xgeva
Agency product number
EMEA/H/C/002173
Active substance
denosumab
International non-proprietary name (INN) or common name
denosumab
Therapeutic area (MeSH)
  • Fractures, Bone
  • Neoplasm Metastasis
Anatomical therapeutic chemical (ATC) code
M05BX04
Publication details
Marketing-authorisation holder
Amgen Europe B.V.
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
13/07/2011
Contact address

Minervum 7061
NL-4817 ZK Breda
The Netherlands

Product information

11/04/2019 Xgeva - EMEA/H/C/002173 - II/0068

Contents

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Pharmacotherapeutic group

DRUGS FOR TREATMENT OF BONE DISEASES

Therapeutic indication

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.  

Assessment history

Changes since initial authorisation of medicine

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