This brand name is authorized in United States. It is also authorized in Australia, Austria, Canada, Croatia, Estonia, Finland, France, Ireland, Italy, Japan, Lithuania, New Zealand, Poland, Romania, Spain, UK.
The drug PAXLOVID contains a combination of these active pharmaceutical ingredients (APIs):
1
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UNII
7R9A5P7H32 - NIRMATRELVIR
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Nirmatrelvir (drug development code: PF-07321332), is a potent and selective peptidomimetic inhibitor of the SARS-CoV-2 3-chymotrypsin like protease, a virally encoded enzyme that is critical to the SARS-CoV-2 replication cycle. |
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2
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UNII
O3J8G9O825 - RITONAVIR
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Ritonavir is an orally active peptidomimetic inhibitor of the HIV-1 and HIV-2 aspartyl proteases. Inhibition of HIV protease renders the enzyme incapable of processing the gag-pol polyprotein precursor which leads to the production of HIV particles with immature morphology that are unable to initiate new rounds of infection. Ritonavir has selective affinity for the HIV protease and has little inhibitory activity against human aspartyl proteases. Pharmacokinetic enhancement by ritonavir is based on ritonavir’s activity as a potent inhibitor of CYP3A-mediated metabolism. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| PAXLOVID Film-coated tablet | MPI, EU: SmPC | European Medicines Agency (EU) | |
| PAXLOVID Film-coated tablet | MPI, US: SPL/PLR | FDA, National Drug Code (US) |
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 | 02524031, 02527804 |
| EE | Ravimiamet | 1872200 |
| ES | Centro de información online de medicamentos de la AEMPS | 1221625001 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 591488 |
| FR | Base de données publique des médicaments | 65579730 |
| IT | Agenzia del Farmaco | 049853017 |
| JP | 医薬品医療機器総合機構 | 62501B5X1020, 62501B5X1038, 62501B5X2026 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1094047 |
| NZ | Medicines and Medical Devices Safety Authority | 22877 |
| PL | Rejestru Produktów Leczniczych | 100464349 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W68795001 |
| US | FDA, National Drug Code | 0069-1085 |
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