EMEA-000366-PIP04-12 - paediatric investigation plan

adalimumab

Key facts

• Invented name:
  • Humira
  • Humira
• Active substance:
  adalimumab
• Therapeutic area:
  Dermatology
• Decision number:
  P/0121/2013
• PIP number:
  EMEA-000366-PIP04-12
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of hidradenitis suppurativa
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  03/05/2013
• Compliance check done:
  Tak
• Compliance procedure number:
  EMEA-C-000366-PIP04-12
• Compliance opinion date:
  01/04/2016
• Compliance outcome:
  Positive

Decision

P/0121/2013: EMA decision of 3 May 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for adalimumab (Humira), (EMEA-000366-PIP04-12)

Adopted Reference Number: EMA/242511/2013