Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Urorec   
Auth. number : EU/1/09/608
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
01/02/2010 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1092 (2010)702 of 29/01/2010
02/02/2010 Centralised - Authorisation EMEA/H/C/1092 (2010)701 of 29/01/2010
10/06/2010 Centralised - Notification EMEA/H/C/1092/N/1
Updated with Decision(2011)2098 of 24/03/2011
23/08/2010 Centralised - Variation EMEA/H/C/1092/IB/2
Updated with Decision(2011)2098 of 24/03/2011
03/01/2011 Centralised - Notification EMEA/H/C/1092/N/3
Updated with Decision(2011)2098 of 24/03/2011
29/03/2011 Centralised - Variation (2011)2098 of 24/03/2011
29/07/2011 Centralised - Notification EMEA/H/C/1092/N/4
Updated with Decision(2012)2836 of 20/04/2012
27/02/2012 Centralised - Notification EMEA/H/C/1092/N/9
Updated with Decision(2012)2836 of 20/04/2012
24/04/2012 Centralised - Variation EMEA/H/C/1092/WS/197 (2012)2836 of 20/04/2012
04/01/2013 Centralised - Variation EMEA/H/C/1092/IB/10
Updated with Decision(2013)8081 of 13/11/2013
15/11/2013 PSUSA - Modification EMEA/H/C/1092/PSU/6 (2013)8081 of 13/11/2013
18/12/2013 Centralised - Variation EMEA/H/C/1092/WS/466/G
Updated with Decision(2014)6789 of 18/09/2014
11/06/2014 Centralised - Notification EMEA/H/C/1092/N/18
Updated with Decision(2014)6789 of 18/09/2014
22/09/2014 Centralised - Renewal EMEA/H/C/1092/R/16 (2014)6789 of 18/09/2014
26/02/2015 Centralised - Variation EMEA/H/C/1092/WS/672/G