MHRA-100203-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • Avacopan
Invented Name
Tavneos
PIP Number MHRA-100203-PIP01-21-M02 (update)
Pharmaceutical form(s)
  • Capsule, hard
  • Age-appropriate oral liquid dosage form
Therapeutic area
Therapeutic area:
  • Immunology -Rheumatology-Transplantation
Conditions / Indications
Conditions / Indications:
  • Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
01/12/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100203-PIP01-21-M02-C2

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):AVACOPAN.pdf
Published Date 14/04/2026