MHRA-100412-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • vadadustat
Invented Name
  • VAFSEO
  • VAFSEO
PIP Number MHRA-100412-PIP01-22-M01 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Age appropriate oral formulation
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of anaemia due to chronic disorders
Route(s) of administration
  • Oral use
  • Other 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
21/02/2022
Compliance Check Procedure Number
Compliance procedure number
MHRA-100412-PIP01-22-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):vadadustat.pdf
Published Date 17/05/2022