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Xofigo



Bayer AGEU/1/13/873/001

Main Information

Trade NameXofigo
Active SubstancesRadium-223 chloride
Dosage FormSolution for injection
Licence HolderBayer AG
Licence NumberEU/1/13/873/001

Group Information

ATC CodeV10XX Various therapeutic radiopharmaceuticals
V10XX03 radium (223Ra) dichloride

Status

License statusAuthorised
Licence Issued13/11/2013
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 StatusNot marketed

Documents

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