EMEA-003154-PIP01-21 - paediatric investigation plan

repagermanium

Key facts

• Active substance:
  repagermanium
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0304/2023
• PIP number:
  EMEA-003154-PIP01-21
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of focal segmental glomerulosclerosis
• 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:
  11/08/2023
• Compliance check done:
  No

Decision

P/0304/2023 : EMA decision of 11 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 repagermanium, (EMEA-003154-PIP01-21)

Reference Number: EMA/336630/2023