EMEA-003026-PIP02-21 - paediatric investigation plan

whole-cell heat-inactivated bacterial strains of Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris and Enterococcus faecalis

Key facts

• Active substance:
  whole-cell heat-inactivated bacterial strains of Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris and Enterococcus faecalis
• Therapeutic area:
  • Infectious diseases
  • Uro-nephrology
  • Vaccines
• Decision number:
  EMA/PE/0000224273
• PIP number:
  EMEA-003026-PIP02-21
• Pharmaceutical form(s):
  Sublingual spray
• Condition(s) / indication(s):
  Prevention of urinary tract infections
• Route(s) of administration:
  Sublingual use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000224273 : EMA decision of 3 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for whole-cell heatinactivated bacterial strains of Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris and Enterococcu

Adopted Reference Number: EMADOC-1700519818-1810838