EMEA-000366-PIP05-12-M02 - paediatric investigation plan

adalimumab

Key facts

• Invented name:
  • Humira
  • Humira
• Active substance:
  adalimumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0200/2016
• PIP number:
  EMEA-000366-PIP05-12-M02
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of non-infectious uveitis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  22/07/2016
• Compliance check done:
  Da
• Compliance procedure number:
  EMEA-C-000366-PIP05-12-M02
• Compliance opinion date:
  14/10/2016
• Compliance outcome:
  Positive

Decision

P/0200/2016: EMA decision of of 22 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for adalimumab (Humira) (EMEA-000366-PIP05-12-M02)

Adopted