![]() ![]() Clinical particulars 4.1 Therapeutic indicationsĬomirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years. The vaccine is a white to off-white frozen dispersion (pH: 6.9 - 7.9). Pharmaceutical formĬoncentrate for dispersion for injection (sterile concentrate). Tozinameran is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.įor the full list of excipients, see section 6.1. One dose (0.2 mL) contains 10 micrograms of tozinameran, a COVID-19 mRNA Vaccine (embedded in lipid nanoparticles). One vial (1.3 mL) contains 10 doses of 0.2 mL after dilution, see sections 4.2 and 6.6. ![]() This is a multidose vial with an orange cap and must be diluted before use. Name of the medicinal productĬomirnaty 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) 2. See section 4.8 for how to report adverse reactions. Healthcare professionals are asked to report any suspected adverse reactions. This will allow quick identification of new safety information. This medicinal product is subject to additional monitoring. The Summary of Product Characteristics for individuals aged 12+ years old can be found here here. This information is for the formulation of the COVID-19 Vaccine Pfizer/BioNTech for individuals aged 5-11 years old.
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