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 info@hpra.ie


Pheburane



Eurocept International BVEU/1/13/822/001

Main Information

Trade NamePheburane
Active SubstancesSodium 4-phenylbutyrate
Dosage FormGranules
Licence HolderEurocept International BV
Licence NumberEU/1/13/822/001

Group Information

ATC CodeA16AX Various alimentary tract and metabolism products
A16AX03 sodium phenylbutyrate

Status

License statusAuthorised
Licence Issued31/07/2013
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 products on restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

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