COMIRNATY

This brand name is authorized in United States. It is also authorized in Austria, Canada, Croatia, Estonia, Finland, France, Ireland, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, South Africa, Spain, Tunisia, UK.

Active ingredients

The drug COMIRNATY contains one active pharmaceutical ingredient (API):

1	Tozinameran UNII 5085ZFP6SJ - TOZINAMERAN
	The nucleoside-modified messenger RNA in COVID-19 mRNA Vaccine BNT162b2 is formulated in lipid nanoparticles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease.
	Read more about Tozinameran

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
COMIRNATY Concentrate for dispersion for injection	MPI, EU: SmPC	European Medicines Agency (EU)
COVID-19 mRNA VACCINE BNT162b2 Concentrate for solution for injection	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)
PFIZER-BIONTECH COVID-19 VACCINE BNT162b2 Suspension for injection	MPI, US: SPL/PLR	FDA, National Drug Code (US)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
J07BN01		J Antiinfectives for systemic use → J07 Vaccines → J07B Viral vaccines → J07BN Covid-19 vaccines
Discover more medicines within J07BN01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
CA	Health Products and Food Branch	02509210
EE	Ravimiamet	1834422, 1864481, 1864492, 1865280, 1865291, 1887947, 1887958, 1888106, 1888117
ES	Centro de información online de medicamentos de la AEMPS	1201528001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	165049, 488024, 516605
FR	Base de données publique des médicaments	60495328
JP	医薬品医療機器総合機構	631341DA1025, 631341DA2021, 631341DA4024, 631341JA1021, 631341JA2028, 631341JA3024
LT	Valstybinė vaistų kontrolės tarnyba	1091557
NL	Z-Index G-Standaard, PRK	206784
NZ	Medicines and Medical Devices Safety Authority	21938, 22857, 22858
PL	Rejestru Produktów Leczniczych	100444490, 100461238, 100462404
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W67224002, W68305001, W68305002, W68306001, W68306002, W69194001, W69194002, W69195001, W69195002, W69238001, W69311001, W69311002
TN	Direction de la Pharmacie et du Médicament	24893012EP
US	FDA, National Drug Code	59267-1000
ZA	Health Products Regulatory Authority	56/30.2/0002