EMEA-000901-PIP03-16-M02 - paediatric investigation plan

Ruxolitinib (phosphate)

Key facts

• Invented name:
  Jakavi
• Active Substance:
  Ruxolitinib (phosphate)
• Therapeutic area:
  Oncology
• Decision number:
  P/0172/2021
• PIP number:
  EMEA-000901-PIP03-16-M02
• Pharmaceutical form(s):
  • Tablet
  • Age-appropriate dosage form
• Condition(s) / indication(s):
  Treatment of acute graft-versus-host disease (aGvHD)
• Route(s) of administration:
  • Oral use
  • Gastric use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/04/2021
• Compliance procedure number:
  EMEA-C-000901-PIP03-16-M02
• Compliance opinion date:
  13/10/2023
• Compliance outcome:
  Positive

Decision

P/0172/2021: EMA decision of 9 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ruxolitinib (phosphate) (Jakavi), (EMEA-000901-PIP03-16-M02)

AdoptedReference Number: EMA/197383/2021