zurück

Ravulizumab (new indication: paroxysmal nocturnal haemoglobinuria (PNH); pediatric patients)

Subject:

  • Active Substance: Ravulizumab
  • Name: Ultomiris®
  • Therapeutic area: Paroxysmal nocturnal haemoglobinuria (PNH)
  • Pharmaceutical company: Alexion Pharma Germany GmbH

Time table:

  • Start: 01.10.2021
  • Final decision by G-BA: 18.03.2022

Final decision:

  • 1) Pediatric patients weighing 10 kg or more with paroxysmal nocturnal hemoglobinuria (PNH) with high disease activity characterized by clinical symptoms of hemolysis: No additional benefit proved
  • 2) Pediatric patients weighing 10 kg or more with paroxysmal nocturnal hemoglobinuria (PNH) who have been receiving eculizumab for ≥ 6 months and are clinically stable: No additional benefit proved