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


Comirnaty Original/Omicron BA.4-5



BioNTech Manufacturing GmbHEU/1/20/1528/012

Main Information

Trade NameComirnaty Original/Omicron BA.4-5
Active SubstancesTozinameran
Dosage FormConcentrate for dispersion for injection
Licence HolderBioNTech Manufacturing GmbH
Licence NumberEU/1/20/1528/012

Group Information

ATC CodeJ07BX03 covid-19 vaccines

Status

License statusAuthorised
Licence Issued10/11/2022
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