EMEA-001741-PIP03-16-M04 - paediatric investigation plan

upadacitinib

Key facts

• Invented name:
  Rinvoq
• Active Substance:
  upadacitinib
• Therapeutic area:
  • Gastroentology-Hepatology
  • Immunology-Rheumatology-Transplantation
• Decision number:
  P/0452/2023
• PIP number:
  EMEA-001741-PIP03-16-M04
• Pharmaceutical form(s):
  • Prolonged-release tablet
  • Age-appropriate oral liquid dosage form
• Condition(s) / indication(s):
  Treatment of Crohn's disease
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/10/2023

Decision

P/0452/2023 : EMA decision of 31 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (Rinvoq), (EMEA-001741-PIP03-16-M04)

AdoptedReference Number: EMA/486034/2023