EMEA-000265-PIP02-11-M04 - paediatric investigation plan

golimumab

Key facts

• Invented name:
  Simponi
• Active substance:
  golimumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0421/2022
• PIP number:
  EMEA-000265-PIP02-11-M04
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of ulcerative colitis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/10/2022
• Compliance check done:
  Da
• Compliance procedure number:
  EMA/PE/0000228734
• Compliance opinion date:
  13/12/2024
• Compliance outcome:
  Positive

Decision

P/0421/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for golimumab (Simponi), (EMEA-000265-PIP02-11-M04)

Adopted Reference Number: EMA/825000/2022