EMEA-003299-PIP02-22 - paediatric investigation plan

Orforglipron

Key facts

• Active Substance:
  Orforglipron
• Therapeutic area:
  Metabolism and nutrition disorders
• Decision number:
  P/0052/2024
• PIP number:
  EMEA-003299-PIP02-22
• Pharmaceutical form(s):
  • Capsule, hard
  • Age-appropriate oral solid dosage form
• 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:
  08/03/2024

Decision

P/0052/2024 : EMA decision of of 8 March 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for orforglipron (EMEA-003299-PIP02-22)

AdoptedReference Number: EMA/53493/2024