Dificlir

fidaxomicin

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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.

What is Dificlir?

Dificlir is a medicine that contains the active substance fidaxomicin. It is available as tablets (200 mg).

What is Dificlir used for?

Dificlir is used to treat adults with infections of the gut caused by bacteria called Clostridium difficile. The medicine can only be obtained with a prescription.

How is Dificlir used?

The recommended dose is one tablet twice a day (every 12 hours) for 10 days.

How does Dificlir work?

C. difficile are bacteria that are present naturally in the gut and do not cause any problems in healthy people. However, some antibiotics that are used to treat infections can interfere with the balance of 'good' bacteria in the gut. When this happens, C. difficile bacteria can multiply and produce toxins (poisons), which cause illness such as diarrhoea and fever. At this point, a person is said to be infected with C. difficile.

The active substance in Dificlir, fidaxomicin, is an antibiotic that belongs to the class of macrocylic antibiotics. When it is swallowed most of the active substance does not get absorbed into the blood stream but acts locally on C. difficile bacteria in the gut. It works by blocking the bacterial enzyme RNA polymerase, which is used to produce the RNA that the bacteria need to make proteins. This stops the C. difficile bacteria from growing and multiplying.

How has Dificlir been studied?

The effects of Dificlir were first tested in experimental models before being studied in humans.

Dificlir has been compared with vancomycin (another antibiotic for C. difficile infections) in two main studies involving a total of 1,147 adult patients with mild to moderately severe C. difficile infection. The main measure of effectiveness was the number of patients that were cured after 10 days of treatment.

What benefit has Dificlir shown during the studies?

Dificlir was at least as effective as vancomycin in curing C. difficile infection. When looking at the results of the two studies, 92% of patients on Dificlir were cured compared with 90% of patients on vancomycin.

What is the risk associated with Dificlir?

The most common side effects with Dificlir (seen in between 1 and 10 patients in 100) are nausea (feeling sick), vomiting and constipation. For the full list of all side effects reported with Dificlir, see the package leaflet.

Dificlir must not be used in people who are hypersensitive (allergic) to fidaxomicin or any of the other ingredients.

Why has Dificlir been approved?

The CHMP considered that Dificlir was effective in curing C. difficile infections and was generally well tolerated with side effects that are similar to vancomycin. The CHMP noted however, that there are uncertainties about the effects of Dificlir in certain groups of patients such as those with liver and kidney problems and recommended that further studies in this group should be carried out. The CHMP considered the severity of C. difficile infections and the drawbacks of current treatments and concluded that benefits of Dificlir are greater than its risks and recommended that it be given marketing authorisation.

Other information about Dificlir

The European Commission granted a marketing authorisation valid throughout the European Union for Dificlir on 5 December 2011.

For more information about treatment with Dificlir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Dificlir : EPAR - Summary for the public BG = bălgarski 19/12/2011  
Dificlir : EPAR - Summary for the public ES = español 19/12/2011  
Dificlir : EPAR - Summary for the public CS = čeština 19/12/2011  
Dificlir : EPAR - Summary for the public DA = dansk 19/12/2011  
Dificlir : EPAR - Summary for the public DE = Deutsch 19/12/2011  
Dificlir : EPAR - Summary for the public ET = eesti keel 19/12/2011  
Dificlir : EPAR - Summary for the public EL = elliniká 19/12/2011  
Dificlir : EPAR - Summary for the public EN = English 19/12/2011  
Dificlir : EPAR - Summary for the public FR = français 19/12/2011  
Dificlir : EPAR - Summary for the public IT = italiano 19/12/2011  
Dificlir : EPAR - Summary for the public LV = latviešu valoda 19/12/2011  
Dificlir : EPAR - Summary for the public LT = lietuvių kalba 19/12/2011  
Dificlir : EPAR - Summary for the public HU = magyar 19/12/2011  
Dificlir : EPAR - Summary for the public MT = Malti 19/12/2011  
Dificlir : EPAR - Summary for the public NL = Nederlands 19/12/2011  
Dificlir : EPAR - Summary for the public PL = polski 19/12/2011  
Dificlir : EPAR - Summary for the public PT = português 19/12/2011  
Dificlir : EPAR - Summary for the public RO = română 19/12/2011  
Dificlir : EPAR - Summary for the public SK = slovenčina 19/12/2011  
Dificlir : EPAR - Summary for the public SL = slovenščina 19/12/2011  
Dificlir : EPAR - Summary for the public FI = suomi 19/12/2011  
Dificlir : EPAR - Summary for the public SV = svenska 19/12/2011  

This EPAR was last updated on 25/04/2014 .

Authorisation details

Product details

Product details for Dificlir
NameDificlir
Agency product numberEMEA/H/C/002087
Active substance

fidaxomicin

International non-proprietary name (INN) or common name

fidaxomicin

Therapeutic area Clostridium Infections
Anatomical therapeutic chemical (ATC) code
Additional monitoring

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

Publication details

Publication details for Dificlir
Marketing-authorisation holder

Astellas Pharma Europe BV

Revision5
Date of issue of marketing authorisation valid throughout the European Union05/12/2011

Contact address:

Astellas Pharma Europe BV
Sylviusweg 62
2333 BE Leiden
The Netherlands

Product information

Product information

21/03/2014  Dificlir -EMEA/H/C/002087 -PSUV/0015

Name Language First published Last updated
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014
Dificlir : EPAR - Product Information SV = svenska 19/12/2011 25/04/2014

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.


Name Language First published Last updated
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  
Dificlir : EPAR - All Authorised presentations SV = svenska 19/12/2011  

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Dificlir : EPAR - Public assessment report SV = svenska 19/12/2011  
CHMP summary of positive opinion for Dificlir SV = svenska 23/09/2011  

Authorised

This medicine is approved for use in the European Union