Paxlovid is an investigational medicine used to treat mild-to-moderate COVID-19 in adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is investigational because it is still being studied. There is limited information about the safety and effectiveness of using Paxlovid to treat people with mild-to-moderate COVID-19.
The FDA has authorized the emergency use of Paxlovid for the treatment of mild-to-moderate COVID-19 in adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with a positive test for the virus that causes COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.

Paxlovid is not an FDA-approved medicine in the United States. Talk to your healthcare provider about your options or if you have any questions. It is your choice to take Paxlovid.

Paxlovid contains two medicines: nirmatrelvir and ritonavir.

Nirmatrelvir [PF-07321332] is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV2 3CL protease inhibitor) that works by inhibiting viral replication in the early stages of the disease to prevent progression to severe COVID-19.

Ritonavir is co-administered with nirmatrelvir to help slow its metabolism in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.

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Proposal 18 Quality Consistency Evaluation projects which have approved 4, and 6 projects are under approving.

Advanced international quality management system has laid solid foundation for sales.

Quality supervision runs through the whole life cycle of the product to ensure the quality and therapeutic effect. 

Professional Regulatory Affairs team supports the quality demands during the application and registration.

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