Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • Edaravone
Invented Name
  • Radicava
  • Radicut
  • Radicut
  • Radicut
PIP Number MHRA-100055-PIP01-21
Pharmaceutical form(s)
  • Solution for infusion
  • Oral suspension
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of Amyotrophic lateral sclerosis
Route(s) of administration
  • Intravenous use
  • 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
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Edaravone.pdf
Published Date 03/11/2021