EMEA-002443-PIP01-18-M02 - paediatric investigation plan

Gepotidacin

Key facts

• Active substance:
  Gepotidacin
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0155/2023
• PIP number:
  EMEA-002443-PIP01-18-M02
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral formulation
• Condition(s) / indication(s):
  Treatment of uncomplicated urinary tract infections
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/05/2023
• Compliance check done:
  No

Decision

P/0155/2023 : EMA decision of 12 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for gepotidacin (EMEA- 002443-PIP01-18-M02)

Reference Number: EMA/170274/2023