MHRA-100412-PIP01-22-M02 (update)

Key Facts

Active Substance
Active Substance:
  • vadadustat
Invented Name
  • VAFSEO
  • VAFSEO
PIP Number MHRA-100412-PIP01-22-M02 (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
Route(s) of administration:
  • Oral use
PIP applicant
  • Akebia Europe Limited
  • Country Ireland
  • Tel +16178712098
  • Email info@akebia.com
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):vadadustat.pdf
Published Date 07/12/2022