MHRA-101389-PIP01-24

Key Facts

Active Substance
Active Substance:
  • omaveloxolone
Invented Name
  • Skyclarys
  • Skyclarys
PIP Number MHRA-101389-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Capsule, hard Age appropriate oral formulation
Therapeutic area
Therapeutic area:
  • Other: Neuromuscular
Conditions / Indications
Conditions / Indications:
  • Treatment of Friedreich's ataxia
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
03/06/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-101389-PIP01-24-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):omaveloxolone.pdf
Published Date 15/08/2024