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


Septabene 1.5 mg/ml + 5.0 mg/ml oromucosal spray, solution



KRKA, d.d., Novo mestoPA1347/049/001

Main Information

Trade NameSeptabene 1.5 mg/ml + 5.0 mg/ml oromucosal spray, solution
Active SubstancesBENZYDAMINE HYDROCHLORIDE
Cetylpyridinium chloride
Dosage FormOromucosal spray, solution
Licence HolderKRKA, d.d., Novo mesto
Licence NumberPA1347/049/001

Group Information

ATC CodeR02AA Antiseptics
R02AA20 various

Status

License statusAuthorised
Licence Issued10/07/2015
Legal statusProduct not subject to medical prescription
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to the general public
Conditions of Licence
Marketing StatusMarketed

Documents

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