Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Dificlir   
Auth. number : EU/1/11/733
Active substance : fidaxomicin
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A07 - Antidiarrheals, intestinal antiinflammatory/antiinfective agents
Pharmacological subgroup: A07A - Intestinal antiinfectives
Chemical subgroup: A07AA - Antibiotics
Chemical substance: A07AA12 - fidaxomicin
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Astellas Pharma Europe B.V.
Sylviusweg 62, 2333 BE Leiden, Nederland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
7/12/2011 Centralised - Authorisation EMEA/H/C/2087 (2011)9174 of 5/12/2011
9/02/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2087/T/1 (2012)818 of 6/02/2012
29/06/2012 Centralised - Variation EMEA/H/C/2087/IA/3/G
Updated with Decision(2012)4490 of 27/06/2012
29/06/2012 Centralised - Variation (2012)4490 of 27/06/2012
29/06/2012 Centralised - Variation EMEA/H/C/2087/IAIN/4/G
Updated with Decision(2012)7886 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7886 of 29/10/2012
17/12/2012 Centralised - Variation EMEA/H/C/2087/IB/7
Updated with Decision(2013)9490 of 13/12/2013
11/01/2013 Centralised - Variation EMEA/H/C/2087/IAIN/8/G
Updated with Decision(2013)9490 of 13/12/2013
27/06/2013 Centralised - Variation EMEA/H/C/2087/II/11
Updated with Decision(2013)9490 of 13/12/2013
16/12/2013 Centralised - Yearly update (2013)9490 of 13/12/2013
26/03/2014 PSUSA - Modification EMEA/H/C/2087/PSU/10 (2014)2047 of 21/03/2014
26/06/2014 Centralised - Variation EMEA/H/C/2087/II/16
Updated with Decision(2015)3720 of 28/05/2015
1/06/2015 Centralised - Yearly update (2015)3720 of 28/05/2015
24/08/2016 Centralised - Renewal EMEA/H/C/2087/R/26 (2016)5493 of 22/08/2016
3/08/2017 Centralised - Variation EMEA/H/C/2087/IA/30
17/05/2018 Centralised - Variation EMEA/H/C/2087/II/32/G