EMEA-002618-PIP02-20-M01 - paediatric investigation plan

ruxolitinib (phosphate)

Key facts

• Invented name:
  • Jakavi
  • Opzelura
• Active substance:
  ruxolitinib (phosphate)
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0102/2024
• PIP number:
  EMEA-002618-PIP02-20-M01
• Pharmaceutical form(s):
  Cream
• Condition(s) / indication(s):
  Treatment of vitiligo
• Route(s) of administration:
  Cutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/04/2024
• Compliance check done:
  Nie

Decision

P/0102/2024: EMA decision of 12 April 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ruxolitinib (phosphate), (Opzelura, Jakavi), (EMEA-002618-PIP02-20-M01)

Adopted Reference Number: EMA/98347/2024