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

Key Facts

PIPS 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
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Compliance Check Decision Date
Compliance opinion date
Compliance Check Procedure Number
Compliance procedure number

Decision Document

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