EMEA-002329-PIP02-20-M03 - paediatric investigation plan

Delgocitinib

Key facts

• Active Substance:
  Delgocitinib
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0533/2023
• PIP number:
  EMEA-002329-PIP02-20-M03
• Pharmaceutical form(s):
  Cream
• Condition(s) / indication(s):
  Treatment of chronic hand eczema
• Route(s) of administration:
  Cutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/12/2023
• Compliance opinion date:
  20/09/2019
• Compliance outcome:
  Positive

Decision

P/0533/2023: EMA decision of 29 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for delgocitinib (EMEA- 002329-PIP02-20-M03)

Reference Number: EMA/562870/2023