EMEA-001882-PIP02-16-M02 - paediatric investigation plan

recombinant human monoclonal antibody to GM-CSF (GSK3196165)

Key facts

• Active substance:
  recombinant human monoclonal antibody to GM-CSF (GSK3196165)
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0266/2020
• PIP number:
  EMEA-001882-PIP02-16-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:
  15/07/2020
• Compliance check done:
  No

Decision

P/0266/2020: EMA decision of 15 July 2020 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant human monoclonal antibody to GM-CSF (otilimab) (EMEA-001882-PIP02-16-M02)

Adopted Reference Number: EMA/365940/2020