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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal PRODUCT is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section for how to report adverse reactions. 1. NAME OF THE medicinal PRODUCT Comirnaty c oncentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION This is a multidose vial and must be diluted before use. One vial ( mL) contains 5 doses of mL after dilution. 1 dose ( mL) contains 30 micrograms of COVID-19 mRNA V accine (embedded in lipid nanoparticles).

This medicinal product is subject to additional monitoring. This will allow quick identification of ... In order to improve the traceability of biological medicinal products, the name and the batch number . ... baseline, was similar to that seen in the general population. Reporting of suspected adverse reactions .

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