EMA/PE/0000240469 - paediatric investigation plan

levonorgestrel

Key facts

• Active substance:
  levonorgestrel
• Therapeutic area:
  Surgical and medical procedures
• Decision number:
  EMA/PE/0000240469
• PIP number:
  EMA/PE/0000240469
• Pharmaceutical form(s):
  Vaginal delivery system
• Condition(s) / indication(s):
  Prevention of pregnancy
• Route(s) of administration:
  Vaginal use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/05/2025
• Compliance check done:
  Nei

Decision

EMA/PE/0000240469 : EMA decision of 16 May 2025 on the acceptance of a modification of an agreed paediatric investigation plan for levonorgestrel

Adopted Reference Number: EMADOC-1700519818-2113975