EMEA-003580-PIP01-24 - paediatric investigation plan

6'-([(1S,3S)-3-([5-(difluoromethoxy)-2- pyrimidinyl]amino)cyclopentyl]amino)-2H- [1,3'-bipyridin]-2-one (AZD0780)

Key facts

• Active substance:
  6'-([(1S,3S)-3-([5-(difluoromethoxy)-2- pyrimidinyl]amino)cyclopentyl]amino)-2H- [1,3'-bipyridin]-2-one (AZD0780)
• Therapeutic area:
  Metabolism and nutrition disorders
• Decision number:
  P/0389/2024
• PIP number:
  EMEA-003580-PIP01-24
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Treatment of elevated cholesterol
  • Treatment of mixed dyslipidaemia
• 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:
  05/12/2024
• Compliance check done:
  No

Decision

P/0389/2024: EMA decision of 5 Dec 2024 on the agreement of a PIP and on granting of a deferral and a waiver for 6'-([(1S,3S)-3-([5-(difluoromethoxy)-2- pyrimidinyl]amino)cyclopentyl] amino)-2H- [1,3'-bipyridin]-2-one (AZD0780) (EMEA-003580-PIP01-24)

Adopted Reference Number: EMA/552707/2024