This brand name is authorized in Austria, Croatia, Cyprus, Estonia, Finland, France, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, Spain, Turkey, UK.
The drug DIFICLIR contains one active pharmaceutical ingredient (API):
1
|
UNII
Z5N076G8YQ - 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. |
|
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| DIFLICIR Film-coated tablet | MPI, EU: SmPC | European Medicines Agency (EU) | |
| DIFICLIR Granules for oral suspension | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| A07AA12 | A Alimentary tract and metabolism → A07 Antidiarrheals, intestinal antiinflammatory/antiinfective agents → A07A Intestinal antiinfectives → A07AA Antibiotics | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| EE | Ravimiamet | 1551114, 1551125, 1551136, 1813991, 1864188 |
| ES | Centro de información online de medicamentos de la AEMPS | 11733004 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 497012 |
| FR | Base de données publique des médicaments | 61973350 |
| GB | Medicines & Healthcare Products Regulatory Agency | 205404 |
| IE | Health Products Regulatory Authority | 88252, 89127 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 7536 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1064202, 1064203, 1089530 |
| NL | Z-Index G-Standaard, PRK | 102466 |
| PL | Rejestru Produktów Leczniczych | 100268076, 100433345 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W67569004 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699586094316 |
© 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.