EMA/PE/0000229480 - paediatric investigation plan

ianalumab

Key facts

• Active substance:
  ianalumab
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  P/0450/2022
• PIP number:
  EMA/PE/0000229480
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Systemic Lupus Erythematosus (SLE)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/04/2025
• Compliance check done:
  No

Decision

EMA/PE/0000229480: EMA decision of 15 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for ianalumab

Adopted Reference Number: EMADOC-1700519818-2039294