Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Silodyx   
Auth. number : EU/1/09/607
Active substance : silodosin
ATC: Anatomical main group: G - Genito urinary system and sex hormones
Therapeutic subgroup: G04 - Urologicals
Pharmacological subgroup: G04C - Drugs used in benign prostatic hypertrophy
Chemical subgroup: G04CA - Alpha-adrenoreceptor antagonists
Chemical substance: G04CA04 - silodosin
(See WHO ATC Index)
Indication: Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.
Marketing Authorisation Holder: Recordati Ireland Ltd
Raheens East, Ringaskiddy Co. Cork, Ireland
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
1/02/2010 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1209 (2010)704 of 29/01/2010
2/02/2010 Centralised - Authorisation EMEA/H/C/1209 (2010)703 of 29/01/2010
10/06/2010 Centralised - Notification EMEA/H/C/1209/N/1
Updated with Decision(2011)2097 of 24/03/2011
23/08/2010 Centralised - Variation EMEA/H/C/1209/IB/2
Updated with Decision(2011)2097 of 24/03/2011
21/10/2010 Centralised - Notification EMEA/H/C/1209/N/3
Updated with Decision(2011)2097 of 24/03/2011
29/03/2011 Centralised - Variation (2011)2097 of 24/03/2011
29/07/2011 Centralised - Notification EMEA/H/C/1209/N/4
Updated with Decision(2012)2835 of 20/04/2012
24/04/2012 Centralised - Variation EMEA/H/C/1209/WS/197 (2012)2835 of 20/04/2012
4/01/2013 Centralised - Variation EMEA/H/C/1209/IB/9
Updated with Decision(2013)8083 of 13/11/2013
24/01/2013 Centralised - Notification EMEA/H/C/1209/N/10
Updated with Decision(2013)8083 of 13/11/2013
15/11/2013 PSUSA - Modification EMEA/H/C/1209/PSU/6 (2013)8083 of 13/11/2013
18/12/2013 Centralised - Variation EMEA/H/C/1209/WS/466/14/G
Updated with Decision(2014)6790 of 18/09/2014
22/09/2014 Centralised - Renewal EMEA/H/C/1209/R/16 (2014)6790 of 18/09/2014
26/02/2015 Centralised - Variation EMEA/H/C/1209/WS/672/G
Updated with Decision(2016)1284 of 24/02/2016
26/02/2016 Centralised - Yearly update (2016)1284 of 24/02/2016
12/04/2018 Centralised - Notification EMEA/H/C/1209/N/30