Italy transposed the European authorisation for Paxlovid (nirmatrelvir/ritonavir) through Resolution No 15 of 31 January 2022, published in Official Gazette No 26 of 1 February 2022. This classifies the medicinal product in class “C non-negotiated [C(nn)]” for the purposes of reimbursement by the National Health Service.  With AIFA Decision No 160/2022 published in Official Gazette No 92 of 20-04-2022 (available in “related documents”), the classification for the supply of Paxlovid has been amended from ‘Restricted prescription medicine to be renewed on a case-by-case basis (RNRL)’ to ‘Renewable Medical Prescription Medicine (RNR)’. (AIFA press release no. 692).

Lagevrio (molnupiravir), an antiviral drug (prodrug metabolised to ribonucleosidic analogue N hydroxycitidine), was suspended by the Agency following the negative opinion issued by EMA’s CHMP on 24/02/2023 for failure to demonstrate a clinical benefit in terms of reduced mortality and hospital admissions. The drug was initially made available through emergency distribution authorisation pursuant to Art. 5.2 of Legislative Decree 219/2006 (Ministerial Decree of 26 November 2021 and subsequent extensions).

The prescription of antivirals for the treatment of COVID-19 is subject to a monitoring register and provides for the use of information sheet for drugs under monitoring available in the lists published on the page “Updated List of Web Based Registries and Therapeutic Plans”. In addition, all antivirals are subject to additional monitoring. This allows for the rapid identification of new safety information. Healthcare professionals are required to report any suspected adverse reactions using the National Pharmacovigilance Network.

AIFA Resolutions No 160/2022, No 15/2022, No 1644/2021 and No 92/2020 are reported below. In addition, the Summary of Product Characteristics (SmPc) and the leaflet are also available for Veklury and Paxlovid.