Regkirona

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regdanvimab

Authorised
This medicine is authorised for use in the European Union.

Overview

Regkirona is a medicine used for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of their disease becoming severe.

Regkirona contains the active substance regdanvimab.
 

This EPAR was last updated on 30/05/2022

Authorisation details

Product details
Name
Regkirona
Agency product number
EMEA/H/C/005854
Active substance
Regdanvimab
International non-proprietary name (INN) or common name
regdanvimab
Therapeutic area (MeSH)
COVID-19 virus infection
Anatomical therapeutic chemical (ATC) code
J06BB
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Celltrion Healthcare Hungary Kft.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
12/11/2021
Contact address

Vaci ut 1-3
WestEnd Office Building B torony
1062 Budapest
Hungary

Product information

25/05/2022 Regkirona - EMEA/H/C/005854 - II/04

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Immune sera and immunoglobulins

Therapeutic indication

Regdanvimab is indicated for the treatment of adults with coronavirus disease 2019 (COVID-19) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

Assessment history

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