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

Key Facts

Active Substance
Active Substance:
  • Avacopan
Invented Name
Tavneos
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 info@viforpharma.com
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
23/11/2021
Compliance Check Procedure Number
Compliance procedure number
MHRA-100203-PIP01-21-M01-C1

Decision Document

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