The State Food and Drug Administration approved the import registration of Merck’s new coronavirus treatment drug Monogravir Capsules with emergency conditions

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36 Krypton learned that, according to the official website of the State Food and Drug Administration, on December 29, the State Food and Drug Administration conducted emergency review and approval in accordance with the relevant provisions of the “Drug Administration Law” and in accordance with the special drug approval procedures, and conditionally approved Merck’s new coronavirus treatment drug Monogravir capsules (trade name: LAGEVRIO) import registration. This product is an oral small-molecule novel coronavirus treatment drug, which is used to treat adults with mild to moderate novel coronavirus infection (COVID-19) patients with high risk factors for severe disease, such as advanced age, obesity or overweight, chronic kidney disease Patients with severe high-risk factors such as disease, diabetes, severe cardiovascular disease, chronic obstructive pulmonary disease, and active cancer. Patients should use the medicine strictly according to the instructions under the guidance of doctors. The State Food and Drug Administration requires the marketing authorization holder to continue to carry out relevant research work, complete the conditional requirements within a time limit, and submit follow-up research results in a timely manner.
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