EMEA-000265-PIP01-08-M04 - paediatric investigation plan

golimumab

Key facts

• Invented name:
  • Simponi
  • Simponi
• Active substance:
  golimumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0226/2014
• PIP number:
  EMEA-000265-PIP01-08-M04
• Pharmaceutical form(s):
  • Solution for injection
  • Solution for infusion
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondylarthritis and juvenile idiopathic arthritis)
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  05/09/2014
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000265-PIP01-08-M04
• Compliance opinion date:
  10/10/2014
• Compliance outcome:
  Positive

Decision

P/0226/2014: EMA decision of 5 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for golimumab (Simponi), (EMEA-000265-PIP01-08-M04)

Adopted Reference Number: EMA/468298/2014