EMA/PE/0000232763 - paediatric investigation plan

icotrokinra

Key facts

• Active substance:
  icotrokinra
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  EMA/PE/0000232763
• PIP number:
  EMA/PE/0000232763
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate oral dosage form
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  20/03/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000232763 : EMA decision of 20 March 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for icotrokinra

Adopted Reference Number: EMADOC-1700519818-1976511