EMA/PE/0000233122 - paediatric investigation plan

Fluocinolone acetonide

Key facts

• Invented name:
  ILUVIEN 190 micrograms intravitreal implant in applicator and associated names
• Active substance:
  Fluocinolone acetonide
• Therapeutic area:
  Eye disorders
• Decision number:
  P/0442/2021
• PIP number:
  EMA/PE/0000233122
• Pharmaceutical form(s):
  Intravitreal implant in applicator
• Condition(s) / indication(s):
  • Secondary prevention of non-infectious uveitis
  • Treatment of chronic non-infectious uveitis
• Route(s) of administration:
  Intravitreal use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/03/2025
• Compliance check done:
  Nē

Decision

EMA/PE/0000233122: EMA decision of 21 March 2025 on the acceptance of a modification of an agreed paediatric investigation plan for fluocinolone acetonide (Iluvien)