EMEA-000315-PIP02-15-M03 - paediatric investigation plan

Osilodrostat

Key facts

• Invented name:
  Isturisa
• Active Substance:
  Osilodrostat
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0135/2023
• PIP number:
  EMEA-000315-PIP02-15-M03
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of adrenal cortical hyperfunction
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Recordati Rare Diseases SARL

  Email: [e-mail]

  Tel: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2023

Decision

P/0135/2023 : EMA decision of 14 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for osilodrostat (Isturisa), (EMEA-000315-PIP02-15-M03)

AdoptedReference Number: EMA/134574/2023