EMEA-001741-PIP01-14-M06 - paediatric investigation plan

upadacitinib

Key facts

• Invented name:
  Rinvoq
• Active Substance:
  upadacitinib
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0237/2023
• PIP number:
  EMEA-001741-PIP01-14-M06
• Pharmaceutical form(s):
  • Age-appropriate oral solid dosage form
  • Age-appropriate oral liquid dosage form
  • Prolonged-release tablet
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)
• Route(s) of administration:
  Oral 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:
  14/06/2023

Decision

P/0237/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (Rinvoq), (EMEA-001741-PIP01-14-M06)

Reference Number: EMA/236245/2023