Decision

Efgartigimod alfa in the treatment of myasthenia gravis (gMG)

EAMS scientific opinion issued to argenx BV for efgartigimod alpha to treat adults with generalised Myasthenia Gravis (gMG), an autoimmune disease that causes muscle weakness. gMG can affect multiple muscle groups throughout the body.

This publication was withdrawn on

Reason: Granting of marketing authorisation

Documents

WITHDRAWN - Efgartigimod alfa - Public Assessment Report (PAR)

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Efgartigimod alfa - Treatment protocol Information for patients

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Efgartigimod alfa - Treatment protocol Information for healthcare professionals

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Efgartigimod alfa - Information for NHS Medical Director

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Efgartigimod alfa - Treatment protocol Information on the Pharmacovigilance System

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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

Published 27 May 2022