EMEA-001776-PIP02-17-M01 - paediatric investigation plan

Risankizumab

Key facts

• Invented name:
  Skyrizi
• Active Substance:
  Risankizumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0039/2021
• PIP number:
  EMEA-001776-PIP02-17-M01
• Pharmaceutical form(s):
  • Solution for injection
  • Age-appropriate pharmaceutical form
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondylarthritis and juvenile idiopathic arthritis)
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  AbbVie Ltd

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/01/2021

Decision

P/0039/2021: EMA decision of 27 January 2021 on the acceptance of a modification of an agreed paediatric investigation plan for risankizumab (Skyrizi), (EMEA-001776-PIP02-17-M01)

AdoptedReference Number: EMA/4608/2021