EMA/PE/0000245851 - paediatric investigation plan

tirzepatide

Key facts

• Invented name:
  Mounjaro
• Active substance:
  tirzepatide
• Therapeutic area:
  Other
• Decision number:
  EMA/PE/0000245851
• PIP number:
  EMA/PE/0000245851
• 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:
  11/07/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000245851 : EMA decision of 11 July 2025 on the acceptance of a modification of an agreed paediatric investigation plan for tirzepatide (Mounjaro)

Adopted Reference Number: EMADOC-1700519818-2221700