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

Comirnaty Omicron XBB. 1.5

BioNTech Manufacturing GmbHEU/1/20/1528/023

Main Information

Trade NameComirnaty Omicron XBB. 1.5
Active SubstancesTozinameran
Dosage FormDispersion for injection
Licence HolderBioNTech Manufacturing GmbH
Licence NumberEU/1/20/1528/023

Group Information

ATC CodeJ07BN01 covid-19, RNA-based vaccine


License statusAuthorised
Licence Issued31/08/2023
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


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