Dificlir

RSS

fidaxomicin

Authorised
This medicine is authorised for use in the European Union.

Overview

Dificlir is a medicine used to treat children and adults with infections of the gut caused by bacteria called Clostridioides difficile.

Dificlir contains the active substance fidaxomicin.

This EPAR was last updated on 11/03/2020

Authorisation details

Product details
Name
Dificlir
Agency product number
EMEA/H/C/002087
Active substance
fidaxomicin
International non-proprietary name (INN) or common name
fidaxomicin
Therapeutic area (MeSH)
Clostridium Infections
Anatomical therapeutic chemical (ATC) code
A07AA12
Publication details
Marketing-authorisation holder
Astellas Pharma Europe BV
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
05/12/2011
Contact address
Sylviusweg 62
2333 BE Leiden
The Netherlands

Product information

13/02/2020 Dificlir - EMEA/H/C/002087 - X/0034/G

Contents

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Pharmacotherapeutic group

Antidiarrheals, intestinal antiinflammatory / antiinfective agents

Therapeutic indication

Dificlir film-coated tablets is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients with a body weight of at least 12.5 kg.

Consideration should be given to official guidelines on the appropriate use of antibacterial agents.

Dificlir granules for oral suspension is indicated for the treatment of Clostridioides  difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adults and paediatric patients from birth to < 18 years of age.

Consideration should be given to official guidelines on the appropriate use of antibacterial agents.

Assessment history

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