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

Bupivacaine 5 mg / mL Solution for injection

Noridem Enterprises LimitedPA1122/029/002

Main Information

Trade NameBupivacaine 5 mg / mL Solution for injection
Active SubstancesBupivacaine hydrochloride, anhydrous
Dosage FormSolution for injection
Licence HolderNoridem Enterprises Limited
Licence NumberPA1122/029/002

Group Information

ATC CodeN01BB01 bupivacaine


License statusAuthorised
Licence Issued14/05/2021
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 StatusNot marketed


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