EMA/PE/0000232764 - paediatric investigation plan

zasocitinib

Key facts

• Active substance:
  zasocitinib
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  EMA/PE/0000232764
• PIP number:
  EMA/PE/0000232764
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis, 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:
  21/03/2025
• Compliance check done:
  No

Decision

EMA/PE/0000232764 : EMA decision of 21 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 zasocitinib

Adopted Reference Number: EMADOC-1700519818-1880459