Medicines, medical devices and blood regulation and safety – decision

Early access to medicines scheme (EAMS) scientific opinion: Nivolumab

This publication was withdrawn on 3 July 2015

The positive scientific opinion for nivolumab has lapsed because it has been granted a marketing authorisation.

Information on the EAMS scientific opinion given to nivolumab, including the public assessment report.

Documents

Nivolumab EAMS public assessment report

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Nivolumab treatment protocol for patients

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Nivolumab treatment protocol for healthcare professionals

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Nivolumab treatment protocol on the pharmacovigilance system

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Detail

This positive scientific opinion was issued to Bristol-Myers Squibb Pharmaceutical Limited on 29 May 2015 for nivolumab, in treatment of advanced (unresectable or metastatic) melanoma in adults.

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 submit an application form to england.eams@nhs.net to register the patient with NHS England. The form itself can be requested from the same dedicated EAMS email address. Plans are underway to introduce a web based application form as soon as possible. Trusts will be informed when this is available.

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. Please email John.Hannah@scotland.gsi.gov.uk and Kathryn.Fergusson@scotland.gsi.gov.uk.

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