Decision

Early access to medicines scheme (EAMS) scientific opinion: sacubitril/valsartan

Information on the EAMS scientific opinion given to sacubitril/valsartan, including the public assessment report.

This publication was withdrawn on

This EAMS scientific opinion has been expired as the product was granted a full marketing authorisation.

Documents

Sacubitril/valsartan EAMS public assessment report (PAR)

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

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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

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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

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Details

This positive scientific opinion was issued to Novartis for sacubitril/valsartan, to reduce the risk of cardiovascular mortality and morbidity in adult patients with symptomatic heart failure and reduced ejection fraction.

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

Heart failure specialists wishing to access this EAMS medicine in England can submit a request to medinfo.uk@novartis.com to register a patient.

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 e-mailing Roger Walker Chief Pharmaceutical Officer at Roger.Walker@wales.gsi.gov.uk and Karen Eveleigh, Head of Pharmacy & Prescribing policy at Karen.Eveleigh@wales.gsi.gov.uk.

Published 1 September 2015