Xgeva

  • Email
  • Help

Questions & Answers

On 22 February 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Xgeva. The marketing authorisation holder for this medicinal product is Amgen Europe B.V.

The CHMP adopted an extension to an existing indication as follows 1:

“Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults withbone metastases from solid tumours advanced malignancies involving bone (see section 5.1).

For information, the full indications for Xgeva will be as follows:

“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.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1New text in bold, removed text as strikethrough

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Xgeva (II-55) (English only) 2018-02-23  

Key facts

Product details for Xgeva
NameXgeva
INN or common name

denosumab

Therapeutic area Neoplasm MetastasisFractures, Bone
Active substance

denosumab

Date opinion adopted22/02/2018
Company name

Amgen Europe B.V.

StatusPositive
Application typePost authorisation