MHRA-100055-PIP01-21

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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

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