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

Budenofalk 4 mg suppositories

Dr. Falk Pharma GmbHPA0573/008/001

Main Information

Trade NameBudenofalk 4 mg suppositories
Active SubstancesBudesonide
Dosage FormSuppository
Licence HolderDr. Falk Pharma GmbH
Licence NumberPA0573/008/001

Group Information

ATC CodeA07EA06 budesonide


License statusAuthorised
Licence Issued10/02/2023
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 StatusNot marketed


Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
« Back