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


Medice Arzneimittel Putter GmbH & Co. K.GEU/1/23/1725/001-002

Main Information

Trade NameVafseo
Active SubstancesVadadustat
Dosage FormFilm-coated tablet
Licence HolderMedice Arzneimittel Putter GmbH & Co. K.G
Licence NumberEU/1/23/1725/001-002

Group Information

ATC CodeB03XA Other antianemic preparations
B03XA08 vadadustat


License statusAuthorised
Licence Issued24/04/2023
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


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