• Active Substance: Satralizumab
  • Name: TBD
  • Therapeutic area: Neuromyelitis optica spectrum disorders (NMOSD)
  • Pharmaceutical company: Roche Pharma AG


Time table:

  • Publication of project plan: 28.04.2021
  • Publication of final assessment: Assessment discontinued due to unexpected changes to the timelines of the EU regulatory procedure.


Assessment information:

  • Title: Satralizumab indicated for the treatment of adult and adolescent patients (≥12 yrs) with neuromyelitis optica spectrum disorders (NMOSD)
  • Author/Co-Author: INFARMED (Portugal), EUR (Netherlands), ZIN (Netherlands)
  • Dedicated Reviewers: AEMPS (Spain), JAZMP (Slovenia), HIS (UK)