MHRA-100720-PIP01-22-M02 (update)

Key Facts

Active Substance
Active Substance:
  • Gepotidacin
Invented Name
Not available at present
PIP Number MHRA-100720-PIP01-22-M02 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Age appropriate oral formulation
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of uncomplicated urinary tract infection
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • GlaxoSmithKline UK Limited
  • Country United Kingdom
  • Tel 00442080475000
  • 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
Yes
Compliance Check Decision Date
Compliance opinion date
28/06/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100720-PIP01-22-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Gepotidacin.pdf
Published Date 24/08/2023