EMA/PE/0000228305 - paediatric investigation plan

Key facts

• Invented name:
  Sotyktu
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0008/2024
• PIP number:
  EMA/PE/0000228305
• Pharmaceutical form(s):
  • Film-coated tablet
  • age-appropriate solid dosage form
• Condition(s) / indication(s):
  Treatment of psoriasis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/03/2025
• Compliance check done:
  Nie

Decision

EMA/PE/0000228305: EMA decision of 21 March 2025 on the acceptance of a modification of an agreed paediatric investigation plan for deucravacitinib (Sotyktu)

Adopted Reference Number: EMADOC-1700519818-1979633