View Alert
Versions:


Originator: CMO Messaging

From: CMO Messaging

Issue date: Originally issued on 03-Jul-2020 16:35:06. This version was issued on 03-Jul-2020 16:35:06

This alert has been issued to:
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Foundation Trusts (England) - Chief Executive
  • NHS Trusts (England) - Medical Director
  • NHS Trusts (England) - Chief Executive

  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Regional Offices
  • Special Health Authorities
  • CMO Urgent Messages - Non-NHS Recipients on Public Health Link
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health
  • Consultants in Communicable Diseases
  • CMO Urgent Messages - Recipients on Public Health Link
  • Director of Public Health

Action category: Important information for immediate action

Title: Publication of an interim clinical commissioning policy: Remdesivir for patients hospitalised with COVID-19 (adults and children of 12 years and older)

Broadcast content:
Update 06 July: We have updated the alert to include updated links to the SmPC and PIL for Remdesivir.

Following confirmation of a Conditional Marketing Authorisation (CMA) by the European Medicines Agency (EMA) for the use of remdesivir in the treatment of COVID-19, the scientific opinion given for remdesivir via the Early Access to Medicines Scheme (EAMS) put in place on 26th May 2020 has now lapsed.

From 3 July 2020, an interim clinical commissioning policy has been put in place to define routine access to remdesivir in the treatment of COVID-19 across the UK.  The policy reflects the conditions of the CMA, but also includes secondary criteria to be used should there be limitations in the supply of remdesivir in the UK.  

Further information can be found in the attached alert; the interim clinical commissioning policy is also attached.


Additional information: This alert does not need to be cascaded to Primary Care.

Alert reference: CEM/CMO/2020/028

Attachments:

Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency