Dificlir (fidaxomicin)
- Region
- 🇪🇺 EU
- Active substance
- fidaxomicin
- Company
- Tillotts Pharma GmbH
- Status
- Authorised
- Therapeutic area
- Clostridium Infections
- CHMP opinion
- Thu 22 Sep 2011
- EU approval
- Mon 05 Dec 2011
- Application
- EMEA/H/C/002087
- ATC
- A07AA12
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.