Basic Information
Dificlir
Regulatory Information
EMEA/H/C/002087
December 5, 2011
September 22, 2011
18
September 30, 2024
Company Information
Germany
Warmbacher Strasse 80 79618 Rheinfelden
Tillotts Pharma Ag
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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.
Overview Summary
Dificlir is a medicine used to treat children and adults with infections of the gut caused by bacteria called Clostridioides difficile. Dificlir contains the active substance fidaxomicin.