EMEA-002350-PIP02-20-M01 - paediatric investigation plan

deucravacitinib

Key facts

• Invented name:
  Sotyktu
• Active substance:
  deucravacitinib
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  P/0319/2024
• PIP number:
  EMEA-002350-PIP02-20-M01
• Pharmaceutical form(s):
  • Age appropriate oral solid dosage form
  • Film-coated tablet
• 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:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0319/2024 : EMA decision of 13 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for deucravacitinib (Sotyktu), (EMEA-002350-PIP02-20-M01)

Adopted Reference Number: EMA/404847/2024