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

Febuxostat Mylan

Mylan Pharmaceuticals LimitedEU/1/17/1194/001-008

Main Information

Trade NameFebuxostat Mylan
Active SubstancesFebuxostat
Dosage FormFilm-coated tablet
Licence HolderMylan Pharmaceuticals Limited
Licence NumberEU/1/17/1194/001-008

Group Information

ATC CodeM04AA Preparations inhibiting uric acid production
M04AA03 febuxostat


License statusAuthorised
Licence Issued15/06/2017
Legal statusProduct subject to prescription which may be renewed (B)
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
« Back