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🇪🇺EU · EMAAuthorisedATC: J07BN01

Comirnaty(single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2)

COVID-19 virus infection

Marketing Authorisation Holder: BioNTech Manufacturing GmbH

EMA Authorisation: 21/12/2020

INN: COVID-19 mRNA vaccine

Indication

Comirnaty JN.1 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Comirnaty JN.1 concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in infants and children aged 6 months to 11 years. The use of this vaccine should be in accordance with official recommendations. Comirnaty KP.2 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Comirnaty LP.8.1 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.