casirivimab / imdevimab
Ronapreve is a medicine used for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe.
The medicine can also be used to prevent COVID-19 in people aged 12 years and older weighing at least 40 kilograms. Ronapreve contains two active substances, casirivimab and imdevimab.
Ronapreve : EPAR - Medicine overview (PDF/122.27 KB)
First published: 12/11/2021
Ronapreve : EPAR - Risk-management-plan (PDF/256.79 KB)
First published: 19/11/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
COVID-19 virus infection
|Anatomical therapeutic chemical (ATC) code||
Roche Registration GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
07/03/2022 Ronapreve - EMEA/H/C/005814 - II/0001
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.
Immune sera and immunoglobulins
Ronapreve is indicated for:
- Treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 (see section 4.2).
- Prevention of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg (see section 4.2).
The use of Ronapreve should take into account information on the activity of Ronapreve against viral variants of concern. See sections 4.4 and 5.1.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 202112/11/2021