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 300 mg/5 mL Nebuliser SolutionTobramycin 300 mg/5 ml Nebuliser Solution



Mylan IRE Healthcare LimitedPA2010/063/001

Main Information

Trade NameTOBI 300 mg/5 mL Nebuliser SolutionTobramycin 300 mg/5 ml Nebuliser Solution
Active SubstancesTobramycin
Dosage FormNebuliser solution
Licence HolderMylan IRE Healthcare Limited
Licence NumberPA2010/063/001

Group Information

ATC CodeJ01GB Other aminoglycosides
J01GB01 tobramycin

Status

License statusAuthorised
Licence Issued15/09/2000
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 CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
« Back