EMEA-002329-PIP02-20-M01 - paediatric investigation plan

Delgocitinib

Key facts

• Active Substance:
  Delgocitinib
• Therapeutic area:
  Dermatology
• Decision number:
  P/0098/2022
• PIP number:
  EMEA-002329-PIP02-20-M01
• Pharmaceutical form(s):
  Cream
• Condition(s) / indication(s):
  Treatment of dermatitis and eczema
• Route(s) of administration:
  Cutaneous use
• Contact for public enquiries:

  LEO Pharma A/S

  Tel. [phone]

  E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/03/2022
• Compliance opinion date:
  20/09/2019
• Compliance outcome:
  Positive

Decision

P/0098/2022 : EMA decision of 11 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for delgocitinib (EMEA- 002329-PIP02-20-M01)

AdoptedReference Number: EMA/105314/2022