EMEA-002360-PIP02-22-M02 - paediatric investigation plan

Tirzepatide

Key facts

• Invented name:
  Mounjaro
• Active Substance:
  Tirzepatide
• Therapeutic area:
  Other
• Decision number:
  P/0478/2023
• PIP number:
  EMEA-002360-PIP02-22-M02
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of obesity
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2023

Decision

P/0478/2023 : EMA decision of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for tirzepatide (Mounjaro), (EMEA-002360-PIP02-22-M02)

Reference Number: EMA/504548/2023