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Importation of MSD's Molnupiravir Capsules approved with condition

CCFDIE| Updated: 2022-12-30

The importation registration of Molnupiravir Capsules (trade name: 利卓瑞/LAGEVRIO) for the treatment of COVID-19 of MSD Inc. is approved with condition for marketing by China NMPA on December 29, through emergency review and approval procedure in accordance with the relevant provisions of special review and approval prescribed in the Drug Administration Law.

This oral small-molecule drug for the treatment of COVID-19 is indicated for treating adult patients with mild to moderate SARS-CoV-2(COVID-19) infection with high risk factors of progressing to severe disease, such as advanced age, obesity or overweight, chronic kidney disease, diabetes, severe cardiovascular disease, chronic obstructive pulmonary disease, active cancer and so on. The patients should use the drug by strictly following the package insert under doctors' guidance.

The MAH is asked by NMPA to complete relevant research works of the conditional requirements within a time limit, and submit the follow-up research results in time.