Decision

Nivolumab in combination with chemotherapy in the treatment of oesophagus and stomach cancer

EAMS scientific opinion issued to Bristol Myers Squibb for nivolumab in combination with chemotherapy for the treatment of cancer of the stomach or oesophagus (gullet) that has spread beyond the stomach or oesophagus

From:
Medicines and Healthcare products Regulatory Agency
Published
24 August 2021

This publication was withdrawn on

marketing authorisation granted

Documents

Nivolumab: Public Assessment Report (PAR)

PDF, 734 KB, 4 pages

This file may not be suitable for users of assistive technology.

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

For the full EAMS indication please see section 4.1 of the Treatment protocol: Information for healthcare professionals.

The scientific opinion includes:

  • a public assessment report (PAR)
  • a treatment protocol:
    • for healthcare professionals
    • for patients
    • on the pharmacovigilance system
  • Information for NHS Medical Directors

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 secondary.care@health-ni.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 24 August 2021