Decision

Early access to medicines scheme (EAMS) scientific opinion: emicizumab for routine prophylaxis of bleeding episodes in patients, aged 1 year and over, with haemophilia A with factor VIII inhibitors

EAMS scientific opinion given to Roche Products Limited for emicizumab for routine prophylaxis of bleeding episodes in patients, aged 1 year and over, with haemophilia A with factor VIII inhibitors including the public assessment report.

From:
Medicines and Healthcare products Regulatory Agency
Published
2 January 2018

This publication was withdrawn on

This positive scientific opinion has been withdrawn because it has been granted an EU licence.

Documents

Emicizumab - public assessment report

PDF, 656 KB, 4 pages

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Details

This positive scientific opinion was issued to Roche Products Limited for emicizumab for routine prophylaxis of bleeding episodes in patients, aged 1 year and over, with haemophilia A with factor VIII inhibitors.

The scientific opinion includes:

  • a public assessment report
  • 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 2 January 2018