EMEA-003313-PIP03-23 - paediatric investigation plan

povorcitinib

Key facts

• Active substance:
  povorcitinib
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0096/2024
• PIP number:
  EMEA-003313-PIP03-23
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of prurigo nodularis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/04/2024
• Compliance check done:
  No

Decision

P/0096/2024: EMA decision of 12 April 2024 on the granting of a product specific waiver for povorcitinib (EMEA-003313-PIP03-23)

Adopted Reference Number: EMA/77768/2024