Italian Medicines Agency Agenzia Italiana del Farmaco

Uso degli anticorpi monoclonali per COVID-19

Use of monoclonal antibodies for COVID-19

Monoclonal antibodies have not yet been fully studied and have not received approval from the European Medicines Agency (EMA). In Italy they have been temporarily authorised by Decree of the Minister of Health of 6 February 2021 published in the Official Gazette of 8 February 2021, no. 32, for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adult and paediatric patients.
The monoclonal antibody bamlanivimab and the bamlanivimab-etesevimab monoclonal antibody combination, manufactured by the pharmaceutical company Eli Lilly, as well as the monoclonal antibody combination casirivimab-imdevimab of the pharmaceutical company Regeneron/Roche, have been temporarily authorised.
The distribution of the medicines is carried out by the extraordinary Commissioner for the implementation and coordination of the containment and contrast measures of the epidemiological emergency COVID-19 pursuant to art. 122 of the decree-law of 17 March 2020, n. 18, according to the methods and procedures defined by the same.
These medicines are subject to additional monitoring. This will allow the rapid identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Weekly reports on currently available monoclonal antibodies with the results of monitoring through the AIFA register (developed in implementation of the Ministry of Health Decree of 6 February 2021) are available on this page.
For each monoclonal antibody (or combination of antibodies) the following information is reported:   

  •     Information for patients
  •     Information for healthcare professionals
  •     Annex I - Terms of use issued by EMA

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