New product: Ronapreve (casirivimab/imdevimab) 120 mg/mL solution for injection or infusion
This product has been granted 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.
Source:
electronic Medicines compendium
SPS commentary:
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.
Roche has issued a Direct Healthcare Professional Communication highlighting that the use of ‘Casirivimab and Imdevimab 120 mg/ml Concentrate for Solution for Infusion’ must be in accordance with the MHRA authorisation for Ronapreve. It is currently not known how long this stock will be on the UK market before authorised stock is supplied.