Decision

Early access to medicines scheme (EAMS) scientific opinion: Atezolizumab for locally advanced or metastatic urothelial carcinoma

EAMS scientific opinion given to Atezolizumab to treat locally advanced or metastatic urothelial carcinoma, including the public assessment report.

Published 23 January 2017
From:
Medicines and Healthcare products Regulatory Agency

This publication was withdrawn on

The EAMS opinion for atezolizumab for locally advanced or metastatic urothelial carcinoma has expired as a marketing authorisation has been granted to a similar medicine covering the EAMS indication. As some patients may still be on treatment, the safety information in the Treatment Protocol have been updated on 19 June 2017. Contact information regarding queries on the use of this EAMS medicine can be found at the end of this document.

Documents

Atezolizumab - Public assessment report (PAR)

PDF, 558KB, 3 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.gsi.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Treatment protocol for patients

PDF, 96.3KB, 7 pages

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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.gsi.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Treatment protocol for healthcare professionals

PDF, 202KB, 18 pages

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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.gsi.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Treatment protocol on the pharmacovigilance system

PDF, 84.3KB, 4 pages

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Details

This positive scientific opinion was issued to Roche Products Limited for Atezolizumab to treat locally advanced or metastatic urothelial carcinoma.

The scientific opinion includes:

  • a public assessment report
  • a treatment protocol:
    • for healthcare professionals
    • for patients
    • on the pharmacovigilance system

Contact

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 Mark Timoney, Chief Pharmaceutical Officer at Mark.Timoney@dhsspsni.gsi.gov.uk 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 email John.Hannah@gov.scot and elisabeth.campbell@gov.soct.

For information about access in Wales, contact the Welsh Government Department of Health and Social Services by emailing Andrew Evans, Interim Chief Pharmaceutical Officer at Andrew.Evans@wales.gsi.gov.uk and Karen Eveleigh, Head of Pharmacy and Prescribing policy at Karen.Eveleigh@wales.gsi.gov.uk.

Published 23 January 2017