EMEA-000315-PIP02-15-M04 - paediatric investigation plan

Osilodrostat

Key facts

• Invented name:
  Isturisa
• Active substance:
  Osilodrostat
• Therapeutic area:
  Endocrine disorders
• Decision number:
  P/0325/2024
• PIP number:
  EMEA-000315-PIP02-15-M04
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of adrenal cortical hyperfunction
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0325/2024 : EMA decision of 13 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for osilodrostat (Isturisa), (EMEA-000315-PIP02-15-M04)

Adopted Reference Number: EMA/412938/2024