Multiple Sclerosis

• CLINICAL_TRIALS safety_alert · 2025-05-13
  Clinical Trial Update: TOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections in Natalizumab Treated Participants

  This document summarizes the TOPIK study update, a completed trial assessing cases of progressive multifocal leukoencephalopathy and other s…

• EMA safety_alert · 2019-11-15
  Measures to minimise risk of serious side effects of multiple sclerosis medicine Lemtrada

  EMA outlines measures to minimise serious side effects associated with Lemtrada (alemtuzumab) for multiple sclerosis, focusing on safety mon…

• EMA safety_alert · 2019-04-12
  Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing

  EMA restricts the use of Lemtrada (alemtuzumab) while ongoing review is concluded, limiting certain patient groups and requiring adherence t…

• EMA safety_alert · 2018-03-07
  EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta

  EMA recommends immediate suspension and recall of Zinbryta due to safety concerns, advising temporary withdrawal from the market.

• EMA safety_alert · 2018-03-02
  EMA urgently reviewing multiple sclerosis medicine Zinbryta following cases of inflammatory brain disorders

  EMA is urgently reviewing the multiple sclerosis medicine Zinbryta due to reported cases of inflammatory brain disorders.

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• EMA safety_alert · 2017-10-27
  PRAC recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk of serious liver damage

  The EMA’s PRAC recommends additional restrictions for Zinbryta (daclizumab) due to risks of serious liver injury, including potential life-t…

• EMA safety_alert · 2017-07-07
  EMA restricts use of multiple sclerosis medicine Zinbryta

  EMA restricts the use of Zinbryta after reports of serious brain inflammation and immune-related conditions; only patients who already benef…

• EMA safety_alert · 2016-02-26
  EMA confirms recommendations to minimise risk of brain infection PML with Tysabri

  EMA confirms recommendations to minimize the risk of progressive multifocal leukoencephalopathy (PML) with Tysabri (natalizumab).