EMEA-000469-PIP01-08-M07 - paediatric investigation plan

anidulafungin

Key facts

• Invented name:
  • Ecalta
  • Ecalta
• Active substance:
  anidulafungin
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0053/2017
• PIP number:
  EMEA-000469-PIP01-08-M07
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of invasive candidiasis
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/03/2017
• Compliance check done:
  Jah
• Compliance procedure number:
  EMEA-C-000469-PIP01-08-M07
• Compliance opinion date:
  26/04/2019
• Compliance outcome:
  Positive

Decision

P/0053/2017: EMA decision of 17 March 2017 on the acceptance of a modification of an agreed paediatric investigation plan for anidulafungin (Ecalta), (EMEA-000469-PIP01-08-M07)

Adopted Reference Number: EMA/90864/2017