EMEA-001451-PIP02-24 - paediatric investigation plan

tildrakizumab

Key facts

• Invented name:
  Ilumetri
• Active substance:
  tildrakizumab
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  P/0388/2024
• PIP number:
  EMEA-001451-PIP02-24
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/11/2024
• Compliance check done:
  Nu

Decision

P/0388/2024: EMA decision of 8 November 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tildrakizumab (Ilumetri), (EMEA-001451-PIP02-24)

Adopted Reference Number: EMA/513587/2024