MHRA-101023-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • ganaxolone
Invented Name
  • ZTALMY
  • ZTALMY
PIP Number MHRA-101023-PIP01-23-M01 (update)
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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

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