My HPRA: Register

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 info@hpra.ie


Evenity



UCB Pharma S.A.EU/1/19/1411/001-002

Main Information

Trade NameEvenity
Active SubstancesROMOSOZUMAB
Dosage FormSolution for injection in pre-filled pen
Licence HolderUCB Pharma S.A.
Licence NumberEU/1/19/1411/001-002

Group Information

ATC CodeM05BX Other drugs affecting bone structure and mineralization
M05BX06 romosozumab

Status

License statusAuthorised
Licence Issued09/12/2019
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back
Follow medicine

Print