EMEA-002360-PIP01-18-M02 - paediatric investigation plan

tirzepatide

Key facts

• Active substance:
  tirzepatide
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0174/2022
• PIP number:
  EMEA-002360-PIP01-18-M02
• 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:
  13/05/2022
• Compliance check done:
  Ne

Decision

P/0174/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tirzepatide (EMEA- 002360-PIP01-18-M02)

Adopted Reference Number: EMA/207913/2022