MHRA-101023-PIP01-23-M02 (update)

Key Facts

Active Substance
Active Substance:
  • ganaxolone
Invented Name
Not yet available
PIP Number MHRA-101023-PIP01-23-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Oral suspension Age appropriate oral liquid formulation
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
09/10/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-101023-PIP01-23-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ganaxolone.pdf
Published Date 19/12/2023