EMEA-001301-PIP02-12-M04 - paediatric investigation plan

Isavuconazonium sulfate

Key facts

• Invented name:
  • Cresemba
  • Cresemba
• Active substance:
  Isavuconazonium sulfate
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0479/2021
• PIP number:
  EMEA-001301-PIP02-12-M04
• Pharmaceutical form(s):
  • Powder for solution for infusion
  • Capsule, hard
• Condition(s) / indication(s):
  • Treatment of invasive aspergillosis
  • Treatment of mucormycosis
• Route(s) of administration:
  • Intravenous use
  • Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/12/2021
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001301-PIP02-12-M04
• Compliance opinion date:
  21/07/2023
• Compliance outcome:
  Positive

Decision

P/0479/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for isavuconazonium (sulfate) (Cresemba), (EMEA-001301-PIP02-12-M04)

Adopted Reference Number: EMA/627435/2021 Corr