Italian Medicines Agency Agenzia Italiana del Farmaco

AIFA defines criteria for use of Paxlovid soon available in Italy - AIFA defines criteria for use of Paxlovid soon available in Italy

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AIFA defines criteria for use of Paxlovid soon available in Italy

Press release No 684 - In its meeting of 28 January 2022AIFA’s Scientific-Technical Committee (CTS), defined the criteria for use of Paxlovid, an oral antiviral for the treatment of COVID-19. The medicinal product had already received a CTS positive opinion in December 2021 for emergency use, and will be available starting from the first week of February 2022.

In the pivotal study, Paxlovid proved effective in reducing the risk of hospitalization and death by 88%. The medicine is indicated for the treatment of recent mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who do not require supplemental oxygen and with underlying clinical conditions that put them at risk of progressing to severe COVID-19. Treatment with Paxlovid must be started within 5 days of symptom onset and lasts 5 days.

The criteria for selecting patients, as well as for prescribing and distributing the medicinal product will be the same as those established for the other oral antiviral (molnupiravir). Paxlovid will be subject to a monitoring register that will be made available through AIFA’s website.


Published on: 28 January 2022

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