MHRA-100829-PIP01-22

Key Facts

Active Substance
Active Substance:
  • Edaravone
Invented Name
Not available at this moment
PIP Number MHRA-100829-PIP01-22
Pharmaceutical form(s)
  • Granules for oral solution
  • Granules for oral solution
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of Amyotrophic lateral sclerosis
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):edaravone.pdf
Published Date 19/12/2023