Swissmedic grants temporary authorisation to Regkirona® for COVID-19 patients

Corona medication Regkirona from iQone Healthcare Switzerland (containing the active substance regdanvimab) granted temporary authorisation in Switzerland

13.01.2022

Swissmedic has granted the medicinal product Regkirona temporary authorisation. Regkirona is an antibody that can be used for treatment of coronavirus disease.

Swissmedic granted Regkirona, concentrate for solution for infusion, temporary authorisation on 12 January 2022. Regkirona is indicated for treatment of COVID-19 in adults if oxygen therapy or hospitalisation is not required due to the disease and there is a high risk of developing a severe form of COVID-19.

Regkirona should be used according to the official recommendations and taking into account the local epidemiological data on the SARS-CoV-2 variants in circulation. The medicinal product contains the antibody regdanvimab and is administered intravenously. Preparation and administration should be initiated and monitored by a qualified healthcare professional.

Swissmedic reviewed the application for authorisation from 26 July 2021 onwards in a rolling review procedure.

The applicant did not submit any information on efficacy against the Omicron variant in connection with this application.

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