EMEA-002023-PIP01-16-M07 - paediatric investigation plan

Avacopan

Key facts

• Invented name:
  Tavneos
• Active Substance:
  Avacopan
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0352/2023
• PIP number:
  EMEA-002023-PIP01-16-M07
• Pharmaceutical form(s):
  • Capsule, hard
  • Age-appropriate oral liquid dosage form
• Condition(s) / indication(s):
  Treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/09/2023

Decision

P/0352/2023 : EMA decision of 8 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for avacopan (Tavneos), (EMEA-002023-PIP01-16-M07)

Reference Number: EMA/380478/2023