EMEA-002004-PIP04-23 - paediatric investigation plan

atacicept

Key facts

• Active substance:
  atacicept
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  EMEA-002004-PIP04-23
• PIP number:
  EMEA-002004-PIP04-23
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of IgA nephropathy
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  16/05/2025
• Compliance check done:
  Nie

Decision

EMEA-002004-PIP04-23 : EMA decision of 16 May 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for atacicept

Adopted Reference Number: EMADOC-1700519818-2112040