EMEA-001301-PIP01-12 - paediatric investigation plan

Isavuconazonium sulfate

Key facts

• Active substance:
  Isavuconazonium sulfate
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0134/2013
• PIP number:
  EMEA-001301-PIP01-12
• Pharmaceutical form(s):
  • Powder for solution for infusion
  • Capsule, hard
• Condition(s) / indication(s):
  Treatment of Candida infections
• Route(s) of administration:
  • Intravenous use
  • Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/06/2013
• Compliance check done:
  No

Decision

P/0134/2013: EMA decision of 14 June 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for isavuconazonium (sulfate) (EMEA-001301-PIP01-12)

Adopted Reference Number: EMA/313498/2013