Ronapreve

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casirivimab / imdevimab

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

Overview

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.

This EPAR was last updated on 21/12/2022

Authorisation details

Product details
Name
Ronapreve
Agency product number
EMEA/H/C/005814
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
J06BD
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
Roche Registration GmbH 
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
12/11/2021
Contact address

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

07/03/2022 Ronapreve - EMEA/H/C/005814 - II/0001

Other EU languages available icon 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:

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

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.

Assessment history

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