Dificlir

RSS

fidaxomicin

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

Overview

This is a summary of the European public assessment report (EPAR) for Dificlir. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dificlir.

This EPAR was last updated on 21/01/2019

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
11
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

31/10/2018 Dificlir - EMEA/H/C/002087 - II/0033

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Anti infectives for systemic use

Therapeutic indication

Dificlir is indicated in adults for the treatment of Clostridium difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD).

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

Assessment history

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