EMEA-000366-PIP01-08-M06 - paediatric investigation plan

adalimumab

Key facts

• Invented name:
  • Humira
  • Humira
• Active substance:
  adalimumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0324/2013
• PIP number:
  EMEA-000366-PIP01-08-M06
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Treatment of psoriasis
  • Treatment of Crohn's disease
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis 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:
  19/12/2013
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000366-PIP01-08-M06
• Compliance opinion date:
  20/06/2014
• Compliance outcome:
  Positive

Decision

P/324/2013: EMA decision of 19 December 2013 on the acceptance of a modification of an agreed paediatric investigation plan for adalimumab (Humira) (EMEA-000366-PIP01-08-M06) in

Adopted Reference Number: EMA/804453/2013