Swissmedic approves "Ronapreve(R)" for COVID-19 patients
Bern, 27.12.2021 - Swissmedic has approved the medicinal product Ronapreve, which was already authorised for prescription in Switzerland under COVID-19 Ordinance 3. Ronapreve is an antibody combination that can be used for treatment or prevention of coronavirus disease.
Swissmedic approved Ronapreve solution for injection/infusion on 23rd December 2021. Ronapreve is indicated in adults and adolescents aged 12 years or older with a bodyweight of at least 40 kg:
- for treatment of COVID-19 if oxygen therapy or hospitalisation is not required and there is a high risk of developing a severe form of COVID-19.
- for prevention of COVID-19 when an adequate immune response to COVID-19 vaccination is not possible.
The product comprises a combination of the antibodies casirivimab and imdevimab. The medicinal product is administered intravenously or subcutaneously (injection under the skin). Preparation and administration should be initiated and monitored by a qualified healthcare professional.
Ronapreve is the first medicinal product approved in Switzerland that can be used to prevent COVID-19 in individuals who cannot mount an adequate immune response to COVID-19 vaccination due to other diseases or treatments.
Swissmedic reviewed the application for authorisation from 5 March 2021 onwards in a rolling submission. This involves continual collection and submission to Swissmedic of the data required. Use of the antibody medication in Switzerland has been permitted since 15 April 2021 based on the exceptions in COVID-19 Ordinance 3.
In this procedure, no data on efficacy against the Omicron variant were submitted.
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