Decision

Asciminib in the treatment of chronic myeloid leukaemia

EAMS scientific opinion issued to Novartis Pharmaceuticals UK Limited for asciminib in the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase without T315I mutation previously treated with tyrosine kinase inhibitors.

This publication was withdrawn on

Withdrawn due to granting of marketing authorisation

Documents

WITHDRAWN - Ascimib: Public Assessment Report (PAR)

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.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Asciminib Treatment protocol Information on the Pharmacovigilance system

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.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Asciminib Treatment protocol Information for healthcare professionals

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.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Asciminib Information for NHS Medical Director

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.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Asciminib Public Assessment Report (PAR)

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.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Asciminib Treatment protocol Information for patients

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.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

For the full EAMS indication please see section 4.1 of the Treatment protocol: Information for healthcare professionals.

The scientific opinion includes:

  • a public assessment report (PAR)
  • a treatment protocol:
  • for healthcare professionals
  • for patients
    • on the pharmacovigilance system
    • Information for NHS Medical Directors

Updates to this page

Published 24 January 2022
Last updated 13 December 2022 + show all updates
  1. Public Assessment Report (PAR) withdrawn

  2. First published.

Sign up for emails or print this page