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Registers Irish medicines Comirnaty XFG 30 micrograms/dose dispersion for injection
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Comirnaty XFG 30 micrograms/dose dispersion for injection

Authorisation EU/1/20/1528/052-055 · BioNTech Manufacturing GmbH

Source: Health Products Regulatory Authority (HPRA), open dataset, CC BY 4.0. Published 16 Sep 2026
Licence holder
BioNTech Manufacturing GmbH (all products →)
Active substance
Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation
Dosage form
Dispersion for injection in pre-filled syringe
ATC code
J07BN01
First authorised
21/12/2020
Prescription status
Product subject to prescription which may not be renewed (A)
Supply
Supply through pharmacies only
Legal basis
New active substance (Article 8(3) of Directive No 2001/83/EC)

This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.