Infliximab - paediatric investigation plan

infliximab

Key facts

• Invented name:
  • Remicade
  • Remicade
• Active substance:
  infliximab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/239/2010
• PIP number:
  Infliximab
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  • Ankylosing spondylitis
  • Juvenile idiopathic arthritis
  • Psoriatic arthritis
  • Rheumatoid arthritis
  • Treatment of Crohn's disease
  • Treatment of psoriasis
  • Treatment of ulcerative colitis
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  05/11/2010
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000549-PIP01-09-M01
• Compliance opinion date:
  16/09/2011
• Compliance outcome:
  Positive

Decision

P/239/2010: EMA decision of 05 November 2010 on the acceptance of a modification of an agreed paediatric investigation plan for infliximab (Remicade), (EMEA-000549-PIP01-09-M01)

Adopted Reference Number: EMA/678121/2010