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.
Dificlir : EPAR - Summary for the public (PDF/54.69 KB)
First published: 19/12/2011
Last updated: 19/12/2011
Dificlir : EPAR - Risk-management-plan summary (PDF/73.6 KB)
First published: 21/01/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Astellas Pharma Europe BV
|Date of issue of marketing authorisation valid throughout the European Union||
31/10/2018 Dificlir - EMEA/H/C/002087 - II/0033
- 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.
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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.