DIFICLIR

This brand name is authorized in Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom

Active ingredients

The drug DIFICLIR contains one active pharmaceutical ingredient (API):

1 Fidaxomicin 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. Read about Fidaxomicin

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
DIFICLIR Granules for oral suspension	European Medicines Agency (EU)	MPI, EU: SmPC
DIFLICIR Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
A07AA12		A Alimentary tract and metabolism → A07 Antidiarrheals, intestinal antiinflammatory/antiinfective agents → A07A Intestinal antiinfectives → A07AA Antibiotics
Discover more medicines within A07AA12

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: EE	Ravimiamet	Identifier(s): 1551114, 1551125, 1551136, 1813991, 1864188
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 11733004
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 497012
Country: FR	Base de données publique des médicaments	Identifier(s): 61973350
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 205404
Country: IE	Health Products Regulatory Authority	Identifier(s): 88252, 89127
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7536
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1064202, 1064203, 1089530
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 102466
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100268076, 100433345
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W67569004
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699586094316