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


Tobi Podhaler



Viatris LimitedEU/1/10/652/001-003

Main Information

Trade NameTobi Podhaler
Active SubstancesTobramycin
Dosage FormInhalation powder, hard capsule
Licence HolderViatris Limited
Licence NumberEU/1/10/652/001-003

Group Information

ATC CodeJ01GB Other aminoglycosides
J01GB01 tobramycin

Status

License statusAuthorised
Licence Issued
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown

Documents

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