Prognia
Drug Database
🇪🇺EU · EMAAuthorisedATC: A07AA12

Dificlir(fidaxomicin)

Clostridium Infections

Marketing Authorisation Holder: Tillotts Pharma GmbH

EMA Authorisation: 05/12/2011

INN: fidaxomicin

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 given to official guidelines on the appropriate use of antibacterial agents.

Official EMA Resources

View on EMA (ema.europa.eu)

AI Drug & Interaction Analysis

Free account required

Ask Prognia AI about Dificlir — dosing recommendations, drug interactions, and current guideline evidence from ESC, EMA, NICE and more.

Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.