Decision

Early access to medicines scheme (EAMS) scientific opinion: Dupilumab for treatment of dermatitis

EAMS scientific opinion given to Dupilumab to treat adult patients with severe atopic dermatitis, including the public assessment report.

From:
Medicines and Healthcare products Regulatory Agency
Published
13 March 2017
Last updated
14 March 2017 — See all updates

This publication was withdrawn on

Withdrawn as this product received a marketing authorisation from the European Commission.

Documents

Dupilumab - Public assessment report

PDF, 638 KB, 3 pages

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Treatment protocol for patients

PDF, 475 KB, 6 pages

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Treatment protocol for healthcare professionals

PDF, 945 KB, 18 pages

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Treatment protocol for patients on the pharmacovigilance system

PDF, 448 KB, 4 pages

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Dupilumab - background information for medical directors

PDF, 159 KB, 2 pages

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Details

This positive scientific opinion was issued to Sanofi for Dupilumab to treat dermatitis. The scientific opinion includes a public assessment report and a treatment protocol:

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

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.scot

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 13 March 2017
Last updated 14 March 2017 + show all updates

  1. Amended treatment protocol for HCPs published

  2. First published.