EMEA-000366-PIP02-09-M06 - paediatric investigation plan

adalimumab

Key facts

• Invented name:
  Humira
• Active substance:
  adalimumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0174/2019
• PIP number:
  EMEA-000366-PIP02-09-M06
• 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:
  15/05/2019
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000366-PIP02-09-M06
• Compliance opinion date:
  30/04/2020
• Compliance outcome:
  Positive

Decision

P/0174/2019: EMA decision of 15 May 2019 on the acceptance of a modification of an agreed paediatric investigation plan for adalimumab (Humira), (EMEA-000366-PIP02-09-M06)

Adopted Reference Number: EMA/241891/2019