Celltrion's COVID-19 tx is approved for sale in Europe
By Chon, Seung-Hyun | translator Choi HeeYoung
21.11.15 08:42:09
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European Commission approves the sales license
It is the first new antibody drug developed in Korea to enter Europe
Regkirona, a COVID-19 antibody treatment developed by Celltrion, has been approved in Europe. Celltrion announced on the 15th that the EC approved Regkirona on the 12th (local time) for the final sale for the purpose of treating COVID-19.
Regkirona has been approved for the treatment of adult patients aged 18 or older who have been confirmed with COVID-19 who do not require oxygen supply and are likely to be severely transmitted. It is a single administration of 60 minutes intravenously, the same as domestic item permission. Regkirona officially received an item license from the EC a day after obtaining an approval recommendation from the CHMP under the European Medicines Agency (EMA) on the 11th.
Chon, Seung-Hyun(1000@dailypharm.com)
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