EMEA-002178-PIP01-17-M01 - paediatric investigation plan

Itacitinib

Key facts

• Active substance:
  Itacitinib
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0414/2019
• PIP number:
  EMEA-002178-PIP01-17-M01
• Pharmaceutical form(s):
  • Prolonged-release tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of acute graft versus host disease
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/12/2019
• Compliance check done:
  No

Decision

P/0414/2019: EMA decision of 6 December 2019 on the acceptance of a modification of an agreed paediatric investigation plan for itacitinib (EMEA-002178-PIP01-17-M01)

Adopted Reference Number: EMA/631719/2019