EMEA-001741-PIP02-16-M02 - paediatric investigation plan

Upadacitinib (ABT-494)

Key facts

• Invented name:
  Rinvoq
• Active Substance:
  Upadacitinib (ABT-494)
• Therapeutic area:
  • Gastroentology-Hepatology
  • Immunology-Rheumatology-Transplantation
• Decision number:
  P/0514/2022
• PIP number:
  EMEA-001741-PIP02-16-M02
• Pharmaceutical form(s):
  • Prolonged-release tablet
  • Age-appropriate oral pharmaceutical form
• Condition(s) / indication(s):
  Treatment of ulcerative colitis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  AbbVie Ltd

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/12/2022

Decision

P/0514/2022 : EMA decision of 6 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (ABT- 494) (Rinvoq), (EMEA-001741-PIP02-16-M02)

AdoptedReference Number: EMA/911625/2022