Subject:
- 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)