My HPRA: Register

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


Fluarix Tetra suspension for injection in pre-filled syringe Influenza vaccine (split virion, inactivated)



GlaxoSmithKline (Ireland) LimitedPA1077/134/001

Main Information

Trade NameFluarix Tetra suspension for injection in pre-filled syringe Influenza vaccine (split virion, inactivated)
Active SubstancesA/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238
A/Darwin/9/2021 (H3N2)-like strain (A/Darwin/6/2021, IVR-227)
B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, BVR-26) [Victoria lineage]
B/PHUKET/3073/2013 -LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE)
Dosage FormSuspension for injection in pre-filled syringe
Licence HolderGlaxoSmithKline (Ireland) Limited
Licence NumberPA1077/134/001

Group Information

ATC CodeJ07BB Influenza vaccines
J07BB02 influenza, inactivated, split virus or surface antigen

Status

License statusAuthorised
Licence Issued01/06/2018
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceConditions Batches of vaccine marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.1 of Directive 2001/83/EC as amended. Commitments The company acknowledges all the CMS comments on the wording in the Product Information (PI) and commits to completing an internal assessment on the request.
Marketing StatusNot marketed

Documents

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

Print