EMEA-002250-PIP02-17-M01 - paediatric investigation plan

ridinilazole (hydrate)

Key facts

• Active substance:
  ridinilazole (hydrate)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0087/2022
• PIP number:
  EMEA-002250-PIP02-17-M01
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral formulation
• Condition(s) / indication(s):
  Treatment of Clostridium difficile infection
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/03/2022
• Compliance check done:
  No

Decision

P/0087/2022 : EMA decision of 11 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ridinilazole (hydrate) (EMEA-002250-PIP02-17-M01)

Adopted Reference Number: EMA/100334/2022