A new formulation of COMIRNATY “12 years of age and older, Ready to use (monovalent Omicron XBB.1.5 Grey Cap and Package, Single-dose or Multi-dose vial)” was approved on 31/08/23 with procedure II/0183.
A new formulation of COMIRNATY “5 to 11 years of age, Ready to use (monovalent Omicron XBB.1.5 Blue Cap and Package, Multi-dose vial)” was approved on 31/08/23 with procedure II/0183.
A new formulation of COMIRNATY “6 months to 4 years of age, Dilute to use (monovalent Omicron XBB.1.5 Maroon Cap and Package, Multi-dose vial)” was approved on 31/08/23 with procedure II/0183.
COMIRNATY Omicron XBB.1.5 (30 micrograms)/dose for dispersion for injection, for 12 years of age and older, Ready to use (Omicron XBB.1.5 Grey Cap and Package, Single-dose of Multi-dose vial)
COMIRNATY Omicron XBB.1.5 (5/5 micrograms)/dose for dispersion for injection, for 5 to 11 years of age, Ready to use (Omicron XBB.1.5 Blue Cap and Package, Multi-dose vial)
COMIRNATY Omicron XBB.1.5 (3 micrograms)/dose for dispersion for injection, for 6 months to 4 years of age, Dilute to use (Omicron XBB.1.5 Maroon Cap and Package, Multi-dose vial)
PP-CMR-EST-0039
Summary of Product Characteristics
Package Leaflet
Contact: +372 666 7500
Marketing Authorisation
Holder: BioNTech
Manufacturing GmbH
COMIRNATY COVID-19 mRNA Vaccine (nucleoside modified), which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.