EMEA-000783-PIP01-09-M06 - paediatric investigation plan

dulaglutide

Key facts

• Invented name:
  Trulicity
• Active substance:
  dulaglutide
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0409/2021
• PIP number:
  EMEA-000783-PIP01-09-M06
• Pharmaceutical form(s):
  Solution for injection in pre-filled pen
• 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:
  29/10/2021
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000783-PIP01-09-M06
• Compliance opinion date:
  24/06/2022
• Compliance outcome:
  Positive

Decision

P/0409/2021 : EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dulaglutide (Trulicity), (EMEA-000783-PIP01-09-M06)

Adopted Reference Number: EMA/535222/2021