EMEA-001741-PIP04-17-M02 - paediatric investigation plan

upadacitinib

Key facts

• Invented name:
  Rinvoq
• Active Substance:
  upadacitinib
• Therapeutic area:
  • Dermatology
  • Immunology-Rheumatology-Transplantation
• Decision number:
  P/0166/2021
• PIP number:
  EMEA-001741-PIP04-17-M02
• Pharmaceutical form(s):
  • Age-appropriate oral liquid dosage form
  • Age-appropriate oral solid dosage form
  • Prolonged-release capsule
  • Prolonged-release tablet
• Condition(s) / indication(s):
  Treatment of atopic dermatitis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2021

Decision

P/0166/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (Rinvoq), (EMEA-001741-PIP04-17-M02)

AdoptedReference Number: EMA/192364/2021