Ronapreve
Withdrawn
This medicine's authorisation has been withdrawn
casirivimab / imdevimab
MedicineHumanWithdrawn
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- Rolling review
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 5 December 2025, the European Commission withdrew the marketing authorisation for Ronapreve (casirivimab / imdevimab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Roche Registration GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Ronapreve was granted marketing authorisation in the EU on 12 November 2021 for the prevention and treatment of COVID-19. The marketing authorisation was initially valid for a 5-year period.
Other COVID-19 medicines are available throughout the EU.
Product information
Latest procedure affecting product information:VR/0000254621
03/04/2025
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).
Product details
- Name of medicine
- Ronapreve
- Active substance
- casirivimab
- imdevimab
- International non-proprietary name (INN) or common name
- casirivimab
- imdevimab
- Therapeutic area (MeSH)
- COVID-19 virus infection
- Anatomical therapeutic chemical (ATC) code
- J06BD07
Pharmacotherapeutic group
Immune sera and immunoglobulinsTherapeutic indication
Ronapreve is indicated for:
- Treatment of COVID-19 in adults, adolescents and children aged 2 years and older weighing at least 10 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
- Treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg and receiving supplemental oxygen, who have a negative SARS-CoV-2 antibody test result.
- Prevention of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg.
Ronapreve should be used in accordance with official recommendations where available and based on information on the activity of casirivimab and imdevimab against presently circulating viral variants.
Assessment history
News on Ronapreve
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