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

Ursofalk 250 mg hard capsules

Primecrown 2010 LimitedPPA1633/016/001

Main Information

Trade NameUrsofalk 250 mg hard capsules
Active SubstancesUrsodeoxycholic acid
Dosage FormCapsule, hard
Licence HolderPrimecrown 2010 Limited
Licence NumberPPA1633/016/001

Group Information

ATC CodeA05AA02 ursodeoxycholic acid


License statusAuthorised
Licence Issued21/12/2011
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 CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
« Back