EMA/PE/0000245149 - paediatric investigation plan

mifepristone

misoprostol

Key facts

• Active substance:
  • mifepristone
  • misoprostol
• Therapeutic area:
  Pregnancy, puerperium and perinatal conditions
• Decision number:
  EMA/PE/0000245149
• PIP number:
  EMA/PE/0000245149
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of termination of pregnancy
• Route(s) of administration:
  • Oral use
  • Buccal use
  • Sublingual use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/06/2025
• Compliance check done:
  No

Decision

EMA/PE/0000245149 : EMA decision of 12 June 2025 on the granting of a product specific waiver for mifepristone, misoprostol

Adopted Reference Number: EMADOC-1700519818-2183651