🇪🇺 Fidaxomicin oral suspension in European Union

EMA authorised Fidaxomicin oral suspension on 5 December 2011

Marketing authorisation

EMA — authorised 5 December 2011

  • Application: EMEA/H/C/002087
  • Marketing authorisation holder: Tillotts Pharma GmbH
  • Local brand name: Dificlir
  • Indication: Dificlir film-coated tablets is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients with a body weight of at least 12.5 kg. Consideration should be given to official guidelines on the appropriate use of antibacterial agents. Dificlir granules for oral suspension is indicated for the treatment of Clostridioides  difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adults and paediatric patients from birth to < 18 years of age. Consideration should be gi
  • Status: approved

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Other Infectious Disease approved in European Union

Frequently asked questions

Is Fidaxomicin oral suspension approved in European Union?

Yes. EMA authorised it on 5 December 2011.

Who is the marketing authorisation holder for Fidaxomicin oral suspension in European Union?

Tillotts Pharma GmbH holds the EU marketing authorisation.