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

Bufomix Easyhaler, 80 micrograms/4.5 micrograms/inhalation, inhalation powder

Orion CorporationPA1327/015/004

Main Information

Trade NameBufomix Easyhaler, 80 micrograms/4.5 micrograms/inhalation, inhalation powder
Active SubstancesBudesonide
Formoterol fumarate dihydrate
Dosage FormInhalation powder
Licence HolderOrion Corporation
Licence NumberPA1327/015/004

Group Information

ATC CodeR03AK Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
R03AK07 formoterol and budesonide


License statusAuthorised
Licence Issued29/04/2016
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 StatusMarketed


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