EMEA-002599-PIP01-19-M01 - paediatric investigation plan

Zoliflodacin

Key facts

• Active Substance:
  Zoliflodacin
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0381/2022
• PIP number:
  EMEA-002599-PIP01-19-M01
• Pharmaceutical form(s):
  Granules for oral suspension
• Condition(s) / indication(s):
  Treatment of gonococcal infection
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Entasis Therapeutic Inc.

  E-mail: [e-mail]; Tel.: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/09/2022

Decision

P/0381/2022 : EMA decision of 9 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for zoliflodacin (EMEA- 002599-PIP01-19-M01)

AdoptedReference Number: EMA/709063/2022