EMEA-000191-PIP01-08-M05

Key facts

Invented name
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 tablets
  • Powder for oral suspension
  • Powder for solution for infusion
Condition(s) / indication(s)
  • Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.
  • Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei)
  • Treatment of candidaemia in non-neutropenic patients
  • Treatment of invasive aspergillosis
Route(s) of administration
  • Oral use
  • Intravenous use
Contact for public enquiries
Pfizer Limited
E-mail: pip_enquiries@pfizer.com
United Kingdom
Tel. +44 (0)1304 646607
Fax +44 (0)1304 653601
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Compliance procedure number
EMEA-C-000191-PIP01-08-M05
Compliance opinion date
09/08/2013
Compliance outcome
positive

Decision

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