MHRA-100714-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Gepotidacin
Invented Name
Not yet available
PIP Number MHRA-100714-PIP01-22-M01 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Age appropriate oral formulation
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of uncomplicated urogenital gonorrhoea (GC)
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • GlaxoSmithKline UK Limited
  • Country United Kingdom
  • Tel 02080475000
  • Email oax52639@gsk.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):Gepotidacin.pdf
Published Date 30/06/2023