Decision

Early access to medicines scheme (EAMS) scientific opinion: Remdesivir in the treatment of patients hospitalised with suspected or laboratory-confirmed SARS-CoV-2 infection who meet the clinical criteria

EAMS scientific opinion issued to Gilead Sciences Ltd for remdesivir in the treatment of patients hospitalised with suspected or laboratory-confirmed SARS-CoV-2 infection who meet the clinical criteria

This publication was withdrawn on

Granting of conditional marketing authorisation. See expired early access to medicines scheme scientific opinions.

Documents

Information for Medical Directors

Early Access to Medicines Scientific Opinion-Public Assessment Report

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

This positive scientific opinion was issued to Gilead Sciences Ltd for remdesivir in the treatment of patients hospitalised with suspected or laboratory-confirmed SARS-CoV-2 infection who meet the clinical criteria

The scientific opinion includes:

  • a public assessment report

  • a treatment protocol:
    • for healthcare professionals
    • for patients
    • on the pharmacovigilance system
  • EAMs scientific opinion – background information for Medical Directors

Contacts

Information and details regarding patient access

For new patients wishing to access EAMS medicines in England, trusts must register patients on the NHS England web based registration system. Queries to NHS England regarding the scheme can be submitted to england.eams@nhs.net

For information about access in Northern Ireland, contact Chief Pharmaceutical Officer and Joe Magee, Secondary Care Directorate at Joe.Magee@dhsspsni.gov.uk

For information about access in Scotland contact the Scottish Government Directorate General Health & Social Care at medicines.policy@gov.scot

For information about access in Wales, contact the Welsh Government Health and Social Services Group by emailing Andrew Evans, Chief Pharmaceutical Officer or Lynne Schofield, Head of Pharmacy and Prescribing policy at Pharmacyand.PrescribingBranch@gov.wales

Published 26 May 2020