The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail


Amgen Europe B.V.EU/1/11/703/001-002

Main Information

Trade NameXGEVA
Active SubstancesDenosumab
Dosage FormSolution for injection
Licence HolderAmgen Europe B.V.
Licence NumberEU/1/11/703/001-002

Group Information

ATC CodeM05BX Other drugs affecting bone structure and mineralization
M05BX04 denosumab


License statusAuthorised
Licence Issued
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown


Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website

Educational Materials - Patient

« Back