EMEA-003396-PIP01-23 - paediatric investigation plan

complement factor B antisense oligonucleotide (RO7434656)

Key facts

• Active substance:
  complement factor B antisense oligonucleotide (RO7434656)
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  P/0517/2023
• PIP number:
  EMEA-003396-PIP01-23
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of primary 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:
  29/12/2023
• Compliance check done:
  No

Decision

P/0517/2023 : EMA decision of 29 December 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for complement factor B antisense oligonucleotide (RO7434656) (EMEA-003396- PIP01-23)

Reference Number: EMA/555156/2023