Decision

Early access to medicines scheme (EAMS) scientific opinion: venetoclax for the treatment of chronic lymphocytic leukaemia (CLL)

EAMS scientific opinion given to venetoclax to treat a type of blood cancer in adults known as chronic lymphocytic leukaemia, including the public assessment report.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 23 August 2016

This publication was withdrawn on 6 December 2016

Withdrawn as this product received a marketing authorisation from the European Commission.

Documents

Venetoclax EAMS public assessment report (PAR)

PDF, 54.3 KB, 3 pages

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Treatment protocol for patients

PDF, 109 KB, 9 pages

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Treatment protocol for healthcare professionals

PDF, 216 KB, 20 pages

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Treatment protocol on the pharmacovigilance system

PDF, 78.6 KB, 3 pages

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Details

This positive scientific opinion was issued to AbbVie Ltd for venetoclax to treat a type of blood cancer in adults known as chronic lymphocytic leukaemia (CLL).

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 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 23 August 2016