EMEA-001045-PIP01-10-M03 - paediatric investigation plan

sarilumab

Key facts

• Invented name:
  Kevzara
• Active substance:
  sarilumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0258/2023
• PIP number:
  EMEA-001045-PIP01-10-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, 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:
  13/07/2023
• Compliance check done:
  Nu

Decision

P/0258/2023 : EMA decision of 13 July 2023 on the acceptance of a modification of an agreed paediatric investigation plan for sarilumab (Kevzara), (EMEA-001045-PIP01-10-M03)

Reference Number: EMA/307256/2023