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
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UNII
Z5N076G8YQ - FIDAXOMICIN
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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. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| DIFICLIR Granules for oral suspension | MPI, EU: SmPC | European Medicines Agency (EU) | |
| DIFLICIR Film-coated tablet | 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 |
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