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 05/07/2018

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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Astellas Pharma Europe BV
Revision
10
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

17/05/2018 Dificlir - EMEA/H/C/002087 - II/0032/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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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