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.

From:
Medicines and Healthcare products Regulatory Agency
Published
24 January 2022
Last updated
13 December 2022 — See all updates

This publication was withdrawn on

Withdrawn due to granting of marketing authorisation

Documents

WITHDRAWN - Ascimib: Public Assessment Report (PAR)

PDF, 700 KB, 4 pages

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Asciminib Treatment protocol Information on the Pharmacovigilance system

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Asciminib Treatment protocol Information on the Pharmacovigilance system

PDF, 150 KB, 4 pages

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Asciminib Treatment protocol Information for healthcare professionals

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Asciminib Treatment protocol Information for healthcare professionals

PDF, 324 KB, 18 pages

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Asciminib Information for NHS Medical Director

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Asciminib Information for NHS Medical Director

PDF, 121 KB, 5 pages

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Asciminib Public Assessment Report (PAR)

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Asciminib Public Assessment Report (PAR)

PDF, 141 KB, 4 pages

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Asciminib Treatment protocol Information for patients

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Asciminib Treatment protocol Information for patients

PDF, 179 KB, 8 pages

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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
Published 24 January 2022
Last updated 13 December 2022 + show all updates

  1. Public Assessment Report (PAR) withdrawn

  2. First published.