EMEA-000636-PIP01-09-M07 - paediatric investigation plan

fidaxomicin

Key facts

• Invented name:
  • Dificlir
  • Dificlir
• Active substance:
  fidaxomicin
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0062/2018
• PIP number:
  EMEA-000636-PIP01-09-M07
• Pharmaceutical form(s):
  • Film-coated tablet
  • Granules for oral suspension
• Condition(s) / indication(s):
  Treatment of enterocolitis caused by Clostridium difficile
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/03/2018
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-000636-PIP01-09-M07
• Compliance opinion date:
  16/11/2018
• Compliance outcome:
  Positive

Decision

P/0062/2018: EMA decision of 16 March 2018 on the acceptance of a modification of an agreed paediatric investigation plan for fidaxomicin (Dificlir), (EMEA-000636-PIP01-09-M07)

Adopted Reference Number: EMA/107498/2018