EMEA-002310-PIP01-17-M01 - paediatric investigation plan

Danicopan

Key facts

• Active Substance:
  Danicopan
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0357/2023
• PIP number:
  EMEA-002310-PIP01-17-M01
• Pharmaceutical form(s):
  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:
  08/09/2023

Decision

P/0357/2023 : EMA decision of 8 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for danicopan (EMEA-002310-PIP01-17-M01)

Reference Number: EMA/347097/2023