Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Tillotts Pharma GmbH, Warmbacher Strasse 80, 79618 Rheinfelden, Germany
DIFICLIR 40 mg/ml granules for oral suspension.
| Pharmaceutical Form |
|---|
|
Granules for oral suspension. White to yellowish white granules. |
Each ml of oral suspension contains 40 mg of fidaxomicin when reconstituted with water.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Fidaxomicin |
Fidaxomicin is an antibiotic belonging to the macrocyclic class of antibacterials. Fidaxomicin is bactericidal and inhibits RNA synthesis by bacterial RNA polymerase. It interferes with RNA polymerase at a distinct site from that of rifamycins. Fidaxomicin is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients. |
| List of Excipients |
|---|
|
Cellulose, microcrystalline |
Amber glass bottle with a polypropylene child-resistant cap in an aluminium pouch containing 7.7 g of granules for oral suspension.
Tillotts Pharma GmbH, Warmbacher Strasse 80, 79618 Rheinfelden, Germany
EU/1/11/733/005
Date of first authorisation: 5 December 2011
Date of latest renewal: 22 August 2016
| Drug | Countries | |
|---|---|---|
| DIFICLIR | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom |
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