EMEA-002618-PIP03-21 - paediatric investigation plan

Ruxolitinib (phosphate)

Key facts

• Invented name:
  Jakavi
• Active Substance:
  Ruxolitinib (phosphate)
• Therapeutic area:
  Dermatology
• Decision number:
  P/0486/2022
• PIP number:
  EMEA-002618-PIP03-21
• Pharmaceutical form(s):
  Cream
• Condition(s) / indication(s):
  Treatment of atopic dermatitis
• Route(s) of administration:
  Cutaneous use
• Contact for public enquiries:

  Incyte Biosciences Distribution B.V.

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  02/12/2022

Decision

P/0486/2022 : EMA decision of 2 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ruxolitinib (phosphate) (Jakavi), (EMEA-002618-PIP03-21)

Reference Number: EMA/871497/2022