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

613b68e7aa40346ca988989a ronapreve-r-casirivimab-and-imdevimab-120-mg-ml-solution-for-injection-or-infusion-important-information-about-the-conditional-marketing-authorisation-product-presentations-and-batch-expiry-dates 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 2021-09-13T07:56:03.522Z 5e283dc93b5e750642253dbe Roche Infection and infectious diseases f48a5fc4-8228-47ec-ba84-e6c8e22ded59 Guidance and advice - Drug prescribing mas_evidence_types:Drug%20prescribing Guidance and advice Letter notes healthcare professionals must follow the MHRA approved conditions for Ronapreve 120 mg/ml Solution for Injection or Infusion when administering ‘Casirivimab and Imdevimab 120 mg/ml Concentrate for Solution for Infusion’. 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). https://www.medicinesresources.nhs.uk/ronapreve-r-casirivimab-and-imdevimab-120-mg-ml-solution-for-injection-or-infusion-important-information-about-the-conditional-marketing-authorisation-product-presentations-and-batch-expiry-dates.html https://www.medicines.org.uk/emc/dhpc/2278/Document 2021-09-10T00:00:00Z 2021-09-10T14:17:11.094Z