MHRA-100203-PIP01-21-M01 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • Avacopan
Invented Name
PIP Number MHRA-100203-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Age appropriate oral solid dosage form
  • Age appropriate oral liquid dosage form
  • Capsule
  • hard
Therapeutic area
Therapeutic area:
  • Immunology -Rheumatology-Transplantation
Conditions / Indications
Conditions / Indications:
  • Treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • Vifor Fresenius Medical Care Renal Pharma France
  • Country France
  • Tel 0041588518000
  • Email
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Compliance Check Decision Date
Compliance opinion date
Compliance Check Procedure Number
Compliance procedure number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Avacopan.pdf
Published Date 17/12/2021