Decision

Early access to medicines scheme (EAMS) scientific opinion: Isatuximab in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma.

EAMS scientific opinion given to Aventis Pharma in the treatment of adult patients with relapsed and refractory multiple myeloma.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 4 December 2019
• Last updated: 17 January 2020 — See all updates

This publication was withdrawn on 5 June 2020

This positive scientific opinion has been withdrawn because it has been granted an EU licence.

Documents

Isatuximab - Public Assessment Report (PAR)

PDF, 676 KB, 3 pages

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Treatment protocol for patients

PDF, 293 KB, 6 pages

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Treatment protocol for healthcare professionals

PDF, 288 KB, 18 pages

Treatment protocol on the pharmacovigilance system

PDF, 117 KB, 4 pages

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Isatuximab - background information for medical directors

PDF, 31.6 KB, 2 pages

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Details

This positive scientific opinion was issued to Aventis Pharma in the treatment of adult patients with relapsed and refractory multiple myeloma.

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

Contacts

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 Chief Pharmaceutical Officer 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 at medicines.policy@gov.scot and Rosemarie.parr@gov.scot.

For information about access in Wales, contact the Welsh Government Health and Social Services Group by emailing Andrew Evans, Chief Pharmaceutical Officer or Lynne Schofield, Head of Pharmacy and Prescribing policy at Pharmacyand.PrescribingBranch@gov.wales

Published 4 December 2019

Last updated 17 January 2020 + show all updates

1. 17 January 2020

   Changes to Early Access to Medicines Scheme – Treatment protocol – Information for healthcare professionals

2. 13 January 2020

   We have updated the published treatment protocol for healthcare professionals

3. 4 December 2019

   First published.