EMA/PE/0000248263 - paediatric investigation plan

leniolisib phosphate

Key facts

• Invented name:
  Joenja
• Active substance:
  leniolisib phosphate
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  EMA/PE/0000248263
• PIP number:
  EMA/PE/0000248263
• Pharmaceutical form(s):
  • Capsule, hard
  • Film-coated tablet
  • Granules
• Condition(s) / indication(s):
  Treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/07/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000248263 : EMA decision of 10 July 2025 on the acceptance of a modification of an agreed paediatric investigation plan for leniolisib phosphate (Joenja)

Adopted Reference Number: EMADOC-1700519818-2258999