Regkirona
regdanvimab
Table of contents
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.
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List item
Regkirona : EPAR - Medicine overview (PDF/119.4 KB)
First published: 12/11/2021
Last updated: 30/11/2021
EMA/629707/2021 -
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Regkirona : EPAR - Risk-management-plan (PDF/748.28 KB)
First published: 12/11/2021
Authorisation details
Product details | |
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Name |
Regkirona
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Agency product number |
EMEA/H/C/005854
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Active substance |
Regdanvimab
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International non-proprietary name (INN) or common name |
regdanvimab
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Therapeutic area (MeSH) |
COVID-19 virus infection
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Anatomical therapeutic chemical (ATC) code |
J06BD06
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Additional 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 | |
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Marketing-authorisation holder |
Celltrion Healthcare Hungary Kft.
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Revision |
8
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Date of issue of marketing authorisation valid throughout the European Union |
12/11/2021
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Contact address |
Vaci ut 1-3 |
Product information
25/08/2023 Regkirona - EMEA/H/C/005854 - IB/0016
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
News
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09/12/2022
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 202112/11/2021
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11/11/2021