EMA/PE/0000237950 - paediatric investigation plan

tirzepatide

Key facts

• Active substance:
  tirzepatide
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  EMA/PE/0000237950
• PIP number:
  EMA/PE/0000237950
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/04/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000237950 : EMA decision of 16 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for tirzepatide (Mounjaro)

Adopted Reference Number: EMADOC-1700519818-2022159