EMEA-003331-PIP02-23 - paediatric investigation plan

mavodelpar

Key facts

• Active substance:
  mavodelpar
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0316/2023
• PIP number:
  EMEA-003331-PIP02-23
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of primary mitochondrial disorders
• 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:
  09/08/2023
• Compliance check done:
  No

Decision

P/0316/2023 : EMA decision of 9 August 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mavodelpar (EMEA-003331-PIP02-23)

Reference Number: EMA/336102/2023