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
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  
 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)
 COMIRNATY Concentrate for dispersion for injection MPI, EU: SmPC European Medicines Agency (EU)

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

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