MHRA-101431-PIP01-24

Key Facts

Active Substance
  • SODIUM PHENYLBUTYRATE
  • Ursodoxicoltaurine
Invented Name
  • Relyvrio
  • Albrioza
PIP Number MHRA-101431-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • All pharmaceutical forms
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of progressive supranuclear palsy
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
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):SODIUM PHENYLBUTYRATEUrsodoxicoltaurine.pdf
Published Date 03/10/2024