EMEA-000128-PIP02-09-M05 - paediatric investigation plan

liraglutide

Key facts

• Invented name:
  Saxenda
• Active substance:
  liraglutide
• Therapeutic area:
  Endocrine disorders
• Decision number:
  P/0468/2023
• PIP number:
  EMEA-000128-PIP02-09-M05
• 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:
  13/12/2023
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000128-PIP02-09-M05
• Compliance opinion date:
  28/06/2024
• Compliance outcome:
  Positive

Decision

P/0468/2023 : EMA decision of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for liraglutide (Saxenda), (EMEA-000128-PIP02-09-M05)

Adopted Reference Number: EMA/512494/2023 Corr.1