EMEA-002944-PIP02-22 - paediatric investigation plan

danuglipron

Key facts

• Active substance:
  danuglipron
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0085/2023
• PIP number:
  EMEA-002944-PIP02-22
• Pharmaceutical form(s):
  • Age appropriate oral dosage formulation
  • Tablet
• Condition(s) / indication(s):
  Treatment of obesity
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  10/03/2023
• Compliance check done:
  No

Decision

P/0085/2023: EMA decision of 10 March 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for danuglipron (EMEA-002944-PIP02-22)

Reference Number: EMA/37959/2023