MHRA-100462-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • FENFLURAMINE HYDROCHLORIDE
Invented Name
  • Fintepla
  • Fintepla
  • Fintepla
  • Fintepla
PIP Number MHRA-100462-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Oral solution
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of Dravet syndrome
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • Zogenix International Limited
  • Country United Kingdom
  • Tel +441628274200
  • Email lmerle@zogenix.com
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):FENFLURAMINE HYDROCHLORIDE.pdf
Published Date 02/02/2023