EMA/PE/0000183059 - paediatric investigation plan

abrocitinib

Key facts

• Invented name:
  Cibinqo
• Active substance:
  abrocitinib
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  EMA/PE/0000183059
• PIP number:
  EMA/PE/0000183059
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral liquid dosage formulation
• 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:
  13/11/2024
• Compliance check done:
  No

Decision

EMA/PE/0000183059: EMA decision of 13 November 2024 on the acceptance of a modification of an agreed paediatric investigation plan for abrocitinib (Cibinqo)

Adopted Reference Number: EMADOC-1700519818-1759464