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Irish Medicines Database · HPRA register

Comirnaty LP.8.1 30 micrograms/dose dispersion for injection in pre-filled syringe

Authorisation EU/1/20/1528/051 · BioNTech Manufacturing GmbH

← All medicines

Comirnaty LP.8.1 30 micrograms/dose dispersion for injection in pre-filled syringe

Licence EU/1/20/1528/051 · Unknown

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)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 04 Jul 2026. 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.