Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Tillotts Pharma GmbH, Warmbacher Strasse 80, 79618 Rheinfelden, Germany
DIFICLIR 200 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Capsule shaped tablets of 14 mm, white to off-white in colour, debossed with “FDX” on one side and “200” on the other side. |
Each film-coated tablet contains 200 mg of fidaxomicin.
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 |
|---|
|
Core tablets: Microcrystalline cellulose Coating: Polyvinyl alcohol |
100 × 1 film-coated tablet in alu/alu perforated unit dose blisters.
20 × 1 film-coated tablet in alu/alu perforated unit dose blisters.
Not all pack sizes may be marketed.
Tillotts Pharma GmbH, Warmbacher Strasse 80, 79618 Rheinfelden, Germany
EU/1/11/733/003-004
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 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
