EMEA-002474-PIP02-18-M02 - paediatric investigation plan

levonorgestrel

Key facts

• Active substance:
  levonorgestrel
• Therapeutic area:
  Surgical and medical procedures
• Decision number:
  P/0163/2024
• PIP number:
  EMEA-002474-PIP02-18-M02
• 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:
  06/05/2024
• Compliance check done:
  No

Decision

P/0163/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for levonogestrel (EMEA- 002474-PIP02-18-M02)

Adopted Reference Number: EMA/176728/2024