Key facts

Active Substance
Gepotidacin
Therapeutic area
Infectious diseases
Decision number
P/0444/2022
PIP number
EMEA-002443-PIP01-18-M01
Pharmaceutical form(s)
  • Age appropriate oral formulation
  • Film-coated tablet
Condition(s) / indication(s)
Treatment of uncomplicated urinary tract infections
Route(s) of administration
Oral use
Contact for public enquiries

GlaxoSmithKline Consumer Trading Services Limited

United Kingdom
E-mail: rd.gskch-paediatric-plans@gsk.com
Tel. +44 (0)19 3282 6987

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

P/0444/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for gepotidacin (EMEA- 002443-PIP01-18-M01)

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