EMEA-000191-PIP01-08-M05 - paediatric investigation plan

voriconazole

Key facts

• Invented name:
  • Vfend
  • Vfend
• Active substance:
  voriconazole
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0151/2013
• PIP number:
  EMEA-000191-PIP01-08-M05
• Pharmaceutical form(s):
  • Film-coated tablet
  • Powder for oral suspension
  • Powder for solution for infusion
• Condition(s) / indication(s):
  • Treatment of candidaemia in non-neutropenic patients
  • Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei)
  • Treatment of invasive aspergillosis
  • Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.
• Route(s) of administration:
  • Oral use
  • Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  05/07/2013
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000191-PIP01-08-M05
• Compliance opinion date:
  09/08/2013
• Compliance outcome:
  Positive

Decision

P/0151/2013: EMA decision of 5 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for voriconazole (Vfend), (EMEA-000191-PIP01-08-M05)

Adopted Reference Number: EMA/342140/2013