EMEA-002917-PIP01-20 - paediatric investigation plan

L-Lactic acid

citric acid

potassium bitartrate

Key facts

• Active Substance:
  • L-Lactic acid
  • citric acid
  • potassium bitartrate
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0378/2021
• PIP number:
  EMEA-002917-PIP01-20
• Pharmaceutical form(s):
  Vaginal gel
• Condition(s) / indication(s):
  • Prevention of Neisseria gonorrhoeae (GC) infection
  • Prevention of urogenital Chlamydia trachomatis (CT) infection
• Route(s) of administration:
  Vaginal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/09/2021

Decision

P/0378/2021 : EMA decision of 8 September 2021 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for L-lactic acid / citric acid / potassium bitartrate, (EMEA-002917-PIP01-20)

AdoptedReference Number: EMA/472041/2021