EMEA-002488-PIP01-18 - paediatric investigation plan

Bardoxolone methyl

Key facts

• Active substance:
  Bardoxolone methyl
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0280/2021
• PIP number:
  EMEA-002488-PIP01-18
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of Alport syndrome
• 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:
  16/07/2021
• Compliance check done:
  No

Decision

P/0280/2021: EMA decision of 16 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for bardoxolone (methyl) (EMEA-002488-PIP01-18)

Reference Number: EMA/384669/2021