EMA/PE/0000227558 - paediatric investigation plan

danicopan

Key facts

• Invented name:
  Voydeya
• Active substance:
  danicopan
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  EMA/PE/0000227558
• PIP number:
  EMA/PE/0000227558
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of paroxysmal nocturnal haemoglobinuria
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/01/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000227558 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for danicopan (Voydeya)

Adopted Reference Number: EMADOC-1700519818-1686602