Decision

Risankizumab in the treatment of moderately to severely active Crohn's disease

EAMS scientific opinion issued to AbbVie Ltd for risankizumab in the treatment of moderately to severely active Crohn's disease in adult patients who did not respond or where contraindicated to tumour necrosis factor-alpha (TNFα) antagonist therapies, vedolizumab and ustekinumab and adolescent patients aged 16 to 17 years who did not respond or where contraindicated to tumour necrosis factor-alpha (TNFα) antagonist therapies.

This publication was withdrawn on

Granting of marketing authorisation

Documents

Risankizumab - Public Assessment Report (PAR)

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Risankizumab - Treatment Protocol - Information for patients

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Risankizumab - Treatment Protocol - Information for healthcare professionals

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Risankizumab - Treatment Protocol - Information on the Pharmacovigilance System

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Risankizumab - Information for NHS Medical Director

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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

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 secondary.care@health-ni.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.

Updates to this page

Published 14 April 2022

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