EMEA-002287-PIP01-17-M03 - paediatric investigation plan

cotadutide

Key facts

• Active substance:
  cotadutide
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0506/2021
• PIP number:
  EMEA-002287-PIP01-17-M03
• 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:
  03/12/2021
• Compliance check done:
  No

Decision

P/0506/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for cotadutide, (EMEA- 002287-PIP01-17-M03)

Adopted Reference Number: EMA/628070/2021