Ronapreve - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

casirivimab / imdevimab

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.

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¹ New text in bold

 

CHMP post-authorisation summary of positive opinion for Ronapreve (II-02)

AdoptedReference Number: EMA/CHMP/80241/2023

Key facts

• Name of medicine:
  Ronapreve
• EMA 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 therapeutical chemical (ATC) code:
  J06BD07
• 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.

• Marketing authorisation holder:
  Roche Registration GmbH
• Date of opinion:
  26/04/2023
• Status:
  Positive