SmPC Updates
Updates to Summary of Product Characteristics include the following:
ADDITION OF 'XFG' VARIANT (EMA/VR/0000355113):
- 12 years of age and older, Ready to use, XFG, Grey Cap
- 6 months to 11 years old, Ready to use, XFG, Blue Cap
For details, please refer to Summary of Product Characteristics for each formulation.
IMPORTANT INFORMATION REGARDING 3mcg FORMULATION
(EMA/VR/0000320534 - 26/05/2026)
Current inventory of COMIRNATY 3mcg can continue to be used until the expiry date on the carton and vial. SmPC and Package Leaflet for the 3mcg formulation can be accessed here:
SmPC: 6 months to 4 years old, Dilute to use, LP.8.1 3 mcg/dose, Yellow Cap
Package Leaflet: 6 months to 4 years old, Dilute to use, LP.8.1 3 mcg/dose, Yellow Cap
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
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Summary of Product Characteristics
Package Leaflet
12 years of age and older, Ready to use, XFG, Grey Cap Package Leaflet
12 years of age and older, Ready to use, LP.8.1, Grey Cap Package Leaflet
12 years and older, Ready to use, Grey Cap Package Leaflet
6 months to 11 years old, Ready to use, XFG, Blue Cap Package Leaflet
6 months to 11 years old, Ready to use, LP.8.1, Blue Cap Package Leaflet
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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.