EMEA-001043-PIP01-10-M03 - paediatric investigation plan

sirukumab

Key facts

• Active substance:
  sirukumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0150/2017
• PIP number:
  EMEA-001043-PIP01-10-M03
• Pharmaceutical form(s):
  • Solution for injection in pre-filled pen
  • Age appropriate dosage form for parenteral use
• 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:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/06/2017
• Compliance check done:
  No

Decision

P/0150/2017: EMA decision of 9 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for sirukumab (EMEA-001043-PIP01-10-M03)

Adopted Reference Number: EMA/318383/2017