EMEA-001292-PIP01-12-M01 - paediatric investigation plan

mifepristone

Key facts

• Active substance:
  mifepristone
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0202/2014
• PIP number:
  EMEA-001292-PIP01-12-M01
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of hypercortisolism (Cushing's syndrome) of endogenous origin
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/08/2014
• Compliance check done:
  Nej

Decision

P/0202/2014: EMA decision of 8 August 2014 on the acceptance of a modification of an agreed paediatric investigation plan for mifepristone (EMEA–001292-PIP01-12-M01)

Adopted Reference Number: EMA/439791/2014