Ronapreve® (casirivimab and imdevimab) 120 mg/ml solution for injection or infusion: Important information about the Conditional Marketing Authorisation, product presentations and batch expiry dates

SPS commentary:

The MHRA has granted Ronapreve® a Conditional Marketing Authorisation for the prophylaxis and treatment of acute Covid-19 infection. Casirivimab and imdevimab are monoclonal antibodies that bind to non-overlapping epitopes of the spike protein receptor binding domain of SARS-CoV-2.

In order to facilitate patient access to treatment, the MHRA has approved a Batch Specific Variation for cartons of ‘Casirivimab and Imdevimab 120 mg/ml Concentrate for Solution for Infusion’, which have been used around the world during the COVID-19 pandemic, for use in the UK under the conditions required for Ronapreve 120 mg/ml Solution for Injection or Infusion. It is currently not known how long this stock will be on the UK market before authorised stock is supplied.

Healthcare professionals must ensure they are using the correct authorised conditions, as outlined in this communication, and that cartons of ‘Casirivimab and Imdevimab 120 mg/ ml Concentrate for Solution for Infusion’ are not used past the expiry date authorised by the MHRA (12 month shelf life; not the 24 month shelf life stated on the cartons).