EMEA-001050-PIP02-18-M02 - paediatric investigation plan

ixekizumab

Key facts

• Invented name:
  Taltz
• Active substance:
  ixekizumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0049/2023
• PIP number:
  EMEA-001050-PIP02-18-M02
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylarthritis and juvenile idiopathic arthritis)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/07/2023
• Compliance check done:
  Kyllä
• Compliance procedure number:
  EMEA-C-001050-PIP02-18-M02
• Compliance opinion date:
  26/07/2024
• Compliance outcome:
  Positive

Decision

P/0049/2023 : EMA decision of 14 July 2023 on the acceptance of a modification of an agreed paediatric investigation plan for ixekizumab (Taltz), (EMEA-001050-PIP02-18-M02)

Reference Number: EMA/287810/2023