EMEA-000901-PIP04-17-M02 - paediatric investigation plan

Ruxolitinib (phosphate)

Key facts

• Invented name:
  • Jakavi
  • Jakavi
• Active Substance:
  Ruxolitinib (phosphate)
• Therapeutic area:
  Oncology
• Decision number:
  P/0527/2021
• PIP number:
  EMEA-000901-PIP04-17-M02
• Pharmaceutical form(s):
  • Tablet
  • Age-appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of chronic Graft versus Host Disease (cGvHD)
• Route(s) of administration:
  • Oral use
  • Gastric use
• Contact for public enquiries:

  Novartis Europharm Limited

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/12/2021

Decision

P/0527/2021: EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ruxolitinib (phosphate) (Jakavi), (EMEA-000901-PIP04-17-M02)

AdoptedReference Number: EMA/626980/2021