This brand name is authorized in Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Tunisia, United Kingdom, United States, South Africa
The drug COMIRNATY contains one active pharmaceutical ingredient (API):
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1
Tozinameran
UNII 5085ZFP6SJ - TOZINAMERAN
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| COVID-19 mRNA VACCINE BNT162b2 Concentrate for solution for injection | Medicines & Healthcare Products Regulatory Agency (GB) | MPI, EU: SmPC | |
| COMIRNATY Concentrate for dispersion for injection | European Medicines Agency (EU) | MPI, EU: SmPC | |
| PFIZER-BIONTECH COVID-19 VACCINE BNT162b2 Suspension for injection | FDA, National Drug Code (US) | MPI, US: SPL/PLR |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| J07BN01 | J Antiinfectives for systemic use → J07 Vaccines → J07B Viral vaccines → J07BN Covid-19 vaccines | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: CA | Health Products and Food Branch | Identifier(s): 02509210 |
| Country: EE | Ravimiamet | Identifier(s): 1834422, 1864481, 1864492, 1865280, 1865291, 1887947, 1887958, 1888106, 1888117 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 1201528001 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 165049, 488024, 516605 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 60495328 |
| Country: JP | 医薬品医療機器総合機構 | Identifier(s): 631341DA1025, 631341DA2021, 631341DA4024, 631341JA1021, 631341JA2028, 631341JA3024 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1091557 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 206784 |
| Country: NZ | Medicines and Medical Devices Safety Authority | Identifier(s): 21938, 22857, 22858 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100444490, 100461238, 100462404 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W67224002, W68305001, W68305002, W68306001, W68306002, W69194001, W69194002, W69195001, W69195002, W69238001, W69311001, W69311002 |
| Country: TN | Direction de la Pharmacie et du Médicament | Identifier(s): 24893012EP |
| Country: US | FDA, National Drug Code | Identifier(s): 59267-1000 |
| Country: ZA | Health Products Regulatory Authority | Identifier(s): 56/30.2/0002 |
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