Ronapreve
Opinion
On 26 April 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Ronapreve. The marketing authorisation holder for this medicinal product is Roche Registration GmbH.
The CHMP adopted an extension to the existing indication to include treatment of COVID-19 in adults and adolescents receiving supplemental oxygen who have a negative SARS-CoV-2 antibody test result. For information, the full indication will therefore be as follows1:
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.
- 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.
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.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1 New text in bold
Key facts
| Name |
Ronapreve |
| Agency product number |
EMEA/H/C/005814 |
| International non-proprietary name (INN) or common name |
|
| Active substance |
|
| Therapeutic area |
COVID-19 virus infection
|
| Additional 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. |
| Date opinion adopted |
26/04/2023 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |