Decision

Avelumab in the treatment of bladder cancer

EAMS scientific opinion issued to Merck Serono Limited for avelumab in the treatment of adults with bladder cancer that has spread beyond the bladder (advanced urothelial carcinoma) if the cancer did not get worse after chemotherapy.

This publication was withdrawn on

This page has been withdrawn as Avelumab has been granted a marketing authorisation.

Documents

Avelumab: Public Assessment Report (PAR)

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Avelumab: Treatment protocol: Information for healthcare professionals

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Avelumab: Treatment protocol: Information for patients

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Avelumab: Treatment protocol: Information on the Pharmacovigilance System

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Avelumab: Information for NHS Medical Directors

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Details

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

The scientific opinion includes:

  • public assessment report
  • a treatment protocol:
    • for healthcare professionals
    • for patients
    • on the pharmacovigilance system
  • background 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 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 2 September 2020
Last updated 17 September 2020 + show all updates
  1. Title change

  2. First published.