Medicinal products containing fluconazole

messages in brief | 03/08/2009

Following the evaluation of the PSUR (Periodic Safety Update Report) in the EU-HBD-Worksharing project, it is currently recommended throughout Europe to include additions to the SmPCs of all medicinal products containing fluconazole.

 

Further information:

  • Core Safety Profile - Fluconazole
  • Sample texts 2009

 

 

Inquiries:

Institute Pharmacovigilance

Dr. Ulrike Rehberger

E-mail: ulrike.rehberger@ages.at

Tel.: +43 (0) 50 555-36258

Email

Further inquiry note