EMEA-002312-PIP01-17-M02 - paediatric investigation plan

abrocitinib

Key facts

• Invented name:
  Cibinqo
• Active Substance:
  abrocitinib
• Therapeutic area:
  Dermatology
• Decision number:
  P/0454/2023
• PIP number:
  EMEA-002312-PIP01-17-M02
• Pharmaceutical form(s):
  • Tablet
  • Age-appropriate oral liquid dosage form
• Condition(s) / indication(s):
  Treatment of atopic dermatitis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/11/2023

Decision

P/0454/2023: EMA decision of 9 November 2023 on the acceptance of a modification of an agreed paediatric investigation plan for abrocitinib (Cibinqo), (EMEA-002312-PIP01-17-M02)

AdoptedReference Number: EMA/494437/2023