EMEA-001437-PIP01-13 - paediatric investigation plan

mifepristone

Key facts

• Active Substance:
  mifepristone
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0202/2013
• PIP number:
  EMEA-001437-PIP01-13
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of leiomyoma of uterus
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  02/09/2013

Decision

P/0202/2013: EMA decision of 2 September 2013 on the granting of a product-specific waiver for mifepristone (EMEA-001437-PIP01-13)

AdoptedReference Number: EMA/483605/2013