EMEA-001741-PIP01-14-M08 - paediatric investigation plan

upadacitinib

Key facts

• Invented name:
  Rinvoq
• Active substance:
  upadacitinib
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  P/0354/2024
• PIP number:
  EMEA-001741-PIP01-14-M08
• Pharmaceutical form(s):
  • Age appropriate oral solid dosage form
  • Age appropriate oral liquid dosage formulation
  • 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
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  25/10/2024
• Compliance check done:
  Ei

Decision

P/0354/2024: EMA decision of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (Rinvoq), (EMEA-001741-PIP01-14-M08)

Adopted Reference Number: EMA/443930/2024