EMA/PE/0000228373 - paediatric investigation plan

Gepotidacin

Key facts

• Active substance:
  Gepotidacin
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0445/2022
• PIP number:
  EMA/PE/0000228373
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate oral formulation
• Condition(s) / indication(s):
  Treatment of uncomplicated urogenital gonorrhea
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/03/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000228373: EMA decision of 21 March 2025 on the acceptance of a modification of an agreed paediatric investigation plan for gepotidacin

Adopted Reference Number: EMADOC-1700519818-1880370