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Atilotrelvir Tablets/Ritonavir Tablets Approved with Conditions

CCFDIE|Updated: 2023-11-24

     

Recently, the Category 1 innovative drug Atilotrelvir Tablets/Ritonavir Tablets (co-packaged) (Chinese trade name: 泰中定) of Fujian Guangsheng Zhonglin Biotechnology Co., Ltd. was approved with conditions by China NMPA through the emergency review and approval procedure in accordance with the relevant provisions of special review and approval prescribed in the Drug Administration Law. This is an oral small-molecule drug for the treatment of SARS-CoV-2(COVID-19) infection, indicated for treating adult patients with mild to moderate COVID-19 infection. 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.