Basic Information
Ronapreve
Regulatory Information
EMEA/H/C/005814
November 12, 2021
November 11, 2021
9
December 13, 2024
Company Information
Germany
Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen
Roche Registration GmbH
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.