EMEA-002618-PIP04-23 - 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/0034/2024
• PIP number:
  EMEA-002618-PIP04-23
• Pharmaceutical form(s):
  Cream
• Condition(s) / indication(s):
  Treatment of prurigo nodularis
• Route(s) of administration:
  Cutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2024
• Compliance check done:
  No

Decision

P/0034/2024 : EMA decision of 31 January 2024 on the granting of a product-specific waiver for ruxolitinib (phosphate) (Jakavi, Opzelura), (EMEA- 002618-PIP04-23)

Adopted Reference Number: EMA/22773/2024