Decision

Pemigatinib in the treatment of cholangioarcinoma

EAMS scientific opinion issued to Incyte Biosciences UK Ltd for pemigatinib in the treatment of adults with locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 fusion or rearrangement that is relapsed or refractory after at least one line of systemic therapy.

From:
Medicines and Healthcare products Regulatory Agency
Published
19 January 2021
Last updated
21 January 2021 — See all updates

This publication was withdrawn on

This page has been withdrawn as Pemigatinib has been granted a marketing authorisation.

Documents

Pemigatinib: Public Assessment Report (PAR)

PDF, 723 KB, 3 pages

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Pemigatinib: Treatment Protocol: Information for healthcare professionals

HTML

Pemigatinib: Treatment protocol: Information for healthcare professionals

PDF, 250 KB, 15 pages

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Pemigatinib:Treatment protocol: Information for patients

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Pemigatinib: Treatment protocol: Information for patients

PDF, 170 KB, 5 pages

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Pemigatinib: Treatment protocol: Information on the Pharmacovigilance System

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Pemigatinib: Treatment protocol: Information on the Pharmacovigilance System

PDF, 110 KB, 4 pages

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Pemigatinib: Information for NHS Medical Directors

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Pemigatinib: Information for NHS Medical Directors

PDF, 115 KB, 4 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 treatment protocol:
    • for healthcare professionals
    • for patients
    • on the pharmacovigilance system
  • Information for NHS Medical Directors

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.

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 19 January 2021
Last updated 21 January 2021 + show all updates

  1. Added Pemigatinib: Treatment protocol: Information on the Pharmacovigilance System in HTML

  2. First published.