Use of antivirals for COVID-19 | Italian Medicines Agency Aifa toggle bar Search Search keywords The Agency The Agency Mission and values Organisation Scientific and Economic Committee for Medicines Support and Coordination Secretariats and Advisory Committees International Collaborations EU Projects Legislation Forms Competition notices Resolutions Tenders and contracts Quality assurance Guarantee Committee Atti di notifica Associazioni dei pazienti AIFA Incontra Contacts Certified email COVID-19 COVID-19 Communications about COVID-19 COVID-19 Vaccines Medicines usable for treatment of COVID-19 disease Use of monoclonal antibodies for COVID-19 Use of antivirals for COVID-19 Monitoring of medicinal products used during the COVID-19 epidemic Clinical Trials - COVID-19 Compassionate Use Programs - COVID-19 Access to medicinal products Access to medicinal products Early access and off-label use Authorisation of medicinal products Medicine shortages Antibiotic medicinal products Biological medicinal products Vaccines Blood derivatives Generic medicinal products Biosimilar medicinal products Orphan medicinal products Advanced therapies Homeopathic medicinal products Allergens Medicinali di origine vegetale Ancillary medicinal substances incorporated in medical devices Safety of medicinal products Safety of medicinal products Pharmacovigilance National Pharmacovigilance Network Adverse Reactions to medicinal products Persons in charge of Pharmacovigilance European Eudravigilance System Accesso alle segnalazioni - ADRreports Regional pharmacovigilance funds Segnali di sicurezza Risk management measures Medicinal products subject to additional monitoring Quality and Inspections Quality and Inspections Quality defects Inspections and authorisations Qualified person Fight of pharmaceutical crime Research and Clinical trials Research and Clinical trials Clinical trials concerning medicinal products EU Regulation on Clinical trials National Observatory on Clinical Trials Registro Studi Osservazionali Comitati Etici Nazionali (CEN) Ethics Committees Coordination Centre Independent clinical research Mappa dei centri di Sperimentazione Clinica Pricing and reimbursement Pricing and reimbursement Negotiation and reimbursement Economic evaluations Monitoring Registers AIFA Notes Lists of Class A and Class H medicinal products Innovative medicinal products Transparency Lists Consumption and pharmaceutical expenditure Consumption and pharmaceutical expenditure The Medicines Utilization Monitoring Centre (OsMed) Governance of pharmaceutical expenditure Monitoring pharmaceutical expenditure Innovation and planning Innovation and planning Innovation and scientific advice Horizon scanning Information and communication Information and communication FarmaciLine Medical and scientific information FAQ Publications Communication campaigns Eventi AIFA Scientific Seminars Press releases Dossier AIFA Mobile APP AIFA APP Firstline AIFA - Antibiotici ABC della Ricerca Clinica Presentations and speeches Public consultations and documents Documents shared with scientific communities Calendario eventi Archivio AIFA data AIFA data OsMed Data Open Data Companies Section Companies Section Requests for authorisation of conferences and meetings Payment of fees and annual duties MA Electronic invoicing Application for reimbursement and pricing Access information Notifica concessionari di vendita Comunicazione prima commercializzazione Open governance Open governance Disposizioni Generali Organizzazione Consulenti e collaboratori Personale Bandi di Concorso Performance Enti controllati Attività e procedimenti Provvedimenti Bandi di gara e contratti Sovvenzioni, contributi, sussidi, vantaggi economici Bilanci Beni immobili e gestione patrimonio Controlli e rilievi sull'Amministrazione Servizi Erogati Pagamenti dell'Amministrazione Opere pubbliche Pianificazione e governo del territorio Informazioni ambientali Interventi straordinari di emergenza Altri Contenuti Use of antivirals for COVID-19 Use of oral antivirals for COVID-19 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. Determine AIFA Determina DG 160/2022 [0.17 Mb] [PDF] > Determina AIFA/15/2022 [1.15 Mb] [PDF] > Determina DG/1644/2021 [0.13 Mb] [PDF] > Determina AIFA/92/2020 [0.38 Mb] [PDF] > Link alla Banca Dati Farmaci Paxlovid (PF-07321332/ritonavir) Veklury (remdesivir) Paxlovid Piano Terapeutico (aggiornamento 4 aprile 2023) [0.1 Mb] [PDF] > Domande e risposte su Paxlovid per gli operatori sanitari [0.28 Mb] [PDF] > Domande e risposte su Paxlovid per i pazienti [0.25 Mb] [PDF] > Leaflet Paxlovid per i pazienti [0.39 Mb] [PDF] > Aggiornamento importante sul periodo di validità - Comunicazione per gli operatori sanitari [0.28 Mb] [PDF] > Aggiornamento importante sul periodo di validità - Comunicazione per i pazienti [0.26 Mb] [PDF] > Lagevrio Allegato 1 alla Determina AIFA 1644/2021 - Informazioni per gli operatori sanitari [0.17 Mb] [PDF] > Allegato 2 alla Determina AIFA 1644/2021 - Informazioni per i pazienti [0.12 Mb] [PDF] > Monitoring of antivirals for COVID-19 Report no. 1 – data relating to weeks 12-18 January 2022 (Veklury) and 13-19 January 2022 (Lagevrio) [0.72 Mb] [PDF] > Report no. 2 - data relating to weeks 19-25 January 2022 (Veklury) and 20-26 January 2022 (Lagevrio) [0.74 Mb] [PDF] > Report no. 3 - data relating to weeks 26 January - 1 February 2022 (Veklury) and 27 January - 2 February 2022 (Lagevrio) [0.9 Mb] [PDF] > Report no. 4 - data relating to weeks 2-8 February 2022 (Veklury) and 3-9 February 2022 (Lagevrio) [0.9 Mb] [PDF] > Report no. 5 - data relating to weeks 16-22 February 2022 (Veklury) and 17-23 February 2022 (Lagevrio, Paxlovid) [1.01 Mb] [PDF] > Report no. 6 - data relating to weeks 2-8 March 2022 (Veklury) and 3-9 March 2022 (Lagevrio, Paxlovid) [0.66 Mb] [PDF] > Report no. 7 - data relating to weeks 16-22 March 2022 (Veklury) and 17-23 March 2022 (Lagevrio, Paxlovid) [0.84 Mb] [PDF] > Report no. 8 - data relating to weeks 30 March - 5 April 2022 (Veklury) and 31 March - 6 April 2022 (Lagevrio, Paxlovid) [0.9 Mb] [PDF] > Report no. 9 - data relating to weeks 13-19 April 2022 (Veklury) and 14-20 April 2022 (Lagevrio, Paxlovid) [0.93 Mb] [PDF] > Report no. 10 - data relating to weeks 27 April - 3 May 2022 (Veklury) and 28 April - 4 May 2022 (Lagevrio, Paxlovid) [0.86 Mb] [PDF] > Report no. 11 - data relating to weeks 11-17 May 2022 (Veklury) and 12-18 May 2022 (Lagevrio, Paxlovid) [0.86 Mb] [PDF] > Report no. 12 - data relating to weeks 1-7 June 2022 (Veklury) and 2-8 June 2022 (Lagevrio, Paxlovid) [0.91 Mb] [PDF] > Report no. 13 - data relating to weeks 15-21 June 2022 (Veklury) and 16-22 June 2022 (Lagevrio, Paxlovid) [0.82 Mb] [PDF] > Report no. 14 - data relating to weeks 29 June - 5 July 2022 (Veklury) and 30 June - 6 July 2022 (Lagevrio, Paxlovid) [1.85 Mb] [PDF] > Report no. 15 - data relating to weeks 13-19 July 2022 (Veklury) and 14-20 July 2022 (Lagevrio, Paxlovid) [0.75 Mb] [PDF] > Report no. 16 - data relating to weeks 3-9 August 2022 (Veklury) and 4-10 August 2022 (Lagevrio, Paxlovid) [0.84 Mb] [PDF] > Report no. 17 - data relating to weeks 17-23 August 2022 (Veklury) and 18-24 August 2022 (Lagevrio, Paxlovid) [0.86 Mb] [PDF] > Report no. 18 - data relating to weeks 31 August - 6 September 2022 (Veklury) and 1-7 September 2022 (Lagevrio, Paxlovid) [0.64 Mb] [PDF] > Report no. 19 - data relating to weeks 14-20 September 2022 (Veklury) and 15-21 September 2022 (Lagevrio, Paxlovid) [0.82 Mb] [PDF] > Report no. 20 - data relating to weeks 28 September - 4 October 2022 (Veklury) and 29 September - 5 October 2022 (Lagevrio, Paxlovid) [0.82 Mb] [PDF] > Report no. 21 - data relating to weeks 12-18 October 2022 (Veklury) and 13-19 October 2022 (Lagevrio, Paxlovid) [0.79 Mb] [PDF] > Report no. 22 - data relating to weeks 26 October - 1 November 2022 (Veklury) and 27 October - 2 November 2022 (Lagevrio, Paxlovid) [0.7 Mb] [PDF] > Report no. 23 - data relating to weeks 9-15 November 2022 (Veklury) and 10-16 November 2022 (Lagevrio, Paxlovid) [0.71 Mb] [PDF] > Report no. 24 - data relating to weeks 23-29 November 2022 (Veklury) and 24-30 November 2022 (Lagevrio, Paxlovid) [0.75 Mb] [PDF] > Report no. 25 - data relating to weeks 7-13 December 2022 (Veklury) and 8-14 December 2022 (Lagevrio, Paxlovid) [0.7 Mb] [PDF] > Report no. 26 - data relating to weeks 21-27 December 2022 (Veklury) and 22-28 December 2022 (Lagevrio, Paxlovid) [0.73 Mb] [PDF] > Report no. 27 - data relating to weeks 4-10 January 2023 (Veklury) and 5-11 January 2023 (Lagevrio, Paxlovid) [0.73 Mb] [PDF] > Report no. 28 - data relating to weeks 18-24 January 2023 (Veklury) and 19-25 January 2023 (Lagevrio, Paxlovid) [0.76 Mb] [PDF] > Report no. 29 - data relating to weeks 15-21 February 2023 (Veklury) and 16-22 February 2023 (Lagevrio, Paxlovid) [0.52 Mb] [PDF] > Report no. 30 - data relating to weeks 1-7 March 2023 (Veklury) and 2-8 March 2023 (Lagevrio, Paxlovid) [0.49 Mb] [PDF] > Report no. 31 - data relating to weeks 15-21 March 2023 (Veklury) and 16-22 March 2023 (Paxlovid) [0.46 Mb] [PDF] > Report no. 32 - data relating to weeks 5-11 April 2023 (Veklury) and 6-12 April 2023 (Paxlovid) [0.46 Mb] [PDF] > Report no. 33 - data relating to weeks 26 April - 2 May 2023 (Veklury) and 27 April - 3 May 2023 (Paxlovid) [0.46 Mb] [PDF] > Report no. 34 - data relating to weeks 10-16 May 2023 (Veklury) and 11-17 May 2023 (Paxlovid) [0.46 Mb] [PDF] > Report no. 35 - data relating to weeks 31 May - 6 June 2023 (Veklury) and 1-7 June 2023 (Paxlovid) [0.46 Mb] [PDF] > Report no. 36 - data relating to weeks 27 June - 2 June 2023 (Veklury, Paxlovid) [0.46 Mb] [PDF] > Report riepilogativo del monitoraggio dei farmaci antivirali e degli anticorpi monoclonali per il COVID-19 [2.07 Mb] [PDF] > Untitled Box link correlati Registries and Therapeutic plans COVID-19 Communications about COVID-19 COVID-19 Vaccines Medicines usable for treatment of COVID-19 disease Use of monoclonal antibodies for COVID-19 Use of antivirals for COVID-19 Monitoring of medicinal products used during the COVID-19 epidemic Clinical Trials - COVID-19 Compassionate Use Programs - COVID-19 Share Nested Applications Highlights 21/04/2026 - Medicine Use: 2024 Regional Reports Now Available Online 17/04/2026 - From one-size-fits-all treatments to personalised care: the revolution in precision medicine TUTTE LE NEWS - 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