Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Emselex   
Auth. number : EU/1/04/294
INN : darifenacin hydrobromide
ATC: Anatomical main group: G - Genito urinary system and sex hormones
Therapeutic subgroup: G04 - Urologicals
Pharmacological subgroup: G04B - Other urologicals, including antispasmodics
Chemical subgroup: G04BD - Urinary antispasmodics
Chemical substance: G04BD10 - Darifenacin
(See WHO ATC Index)
Indication: Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome
Marketing Authorisation Holder: Merus Labs Luxco S. R.L.
26-28, rue Edward Steichen, L-2540 Luxembourg

  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
26/10/2004 Centralised - Authorisation EMEA/H/C/554 (2004)4244 of 22/10/2004
20/12/2004 Centralised - Variation EMEA/H/C/554/N/1
Updated with Decision(2005)4538 of 17/11/2005
30/05/2005 Centralised - Variation EMEA/H/C/554/IA/2
Updated with Decision(2005)4538 of 17/11/2005
06/07/2005 Centralised - Variation EMEA/H/C/554/IB/3
26/07/2005 Centralised - Variation EMEA/H/C/554/IA/4
26/07/2005 Centralised - Variation EMEA/H/C/554/IA/16
26/07/2005 Centralised - Variation EMEA/H/C/554/IA/7
Updated with Decision(2005)4538 of 17/11/2005
26/07/2005 Centralised - Variation EMEA/H/C/554/IA/17
17/08/2005 Centralised - Variation EMEA/H/C/554/IB/8
17/08/2005 Centralised - Variation EMEA/H/C/554/IB/11
17/08/2005 Centralised - Variation EMEA/H/C/554/IB/13
17/08/2005 Centralised - Variation EMEA/H/C/554/IB/14
17/08/2005 Centralised - Variation EMEA/H/C/554/IB/12
23/09/2005 Centralised - Variation EMEA/H/C/554/IA/19
Updated with Decision(2005)4538 of 17/11/2005
23/09/2005 Centralised - Variation EMEA/H/C/554/II/15
20/10/2005 Centralised - Variation EMEA/H/C/554/II/9
21/11/2005 Centralised - Variation EMEA/H/C/554/II/10 (2005)4538 of 17/11/2005
25/05/2006 Centralised - Variation EMEA/H/C/554/N/20
Updated with Decision(2006)5930 of 29/11/2006
06/07/2006 Centralised - Variation EMEA/H/C/554/II/21
01/12/2006 Centralised - Variation EMEA/H/C/554/II/22 (2006)5930 of 29/11/2006
27/03/2007 Centralised - Variation EMEA/H/C/554/II/23 (2007)1450 of 23/03/2007
27/06/2007 Centralised - Variation EMEA/H/C/554/IA/25
27/06/2007 Centralised - Variation EMEA/H/C/554/IA/26
09/08/2007 Centralised - Variation EMEA/H/C/554/N/24
Updated with Decision(2008)1699 of 23/04/2008
12/10/2007 Centralised - Variation EMEA/H/C/554/IA/27
19/12/2007 Centralised - Variation EMEA/H/C/554/N/28
Updated with Decision(2008)1699 of 23/04/2008
25/04/2008 Centralised - Variation EMEA/H/C/554/II/32 (2008)1699 of 23/04/2008
27/08/2008 Centralised - Variation EMEA/H/C/554/II/34 (2008)4680 of 25/08/2008
05/03/2009 Centralised - Variation EMEA/H/C/554/IA/38
04/08/2009 Centralised - Variation EMEA/H/C/554/II/40 (2009)6241 of 31/07/2009
28/09/2009 Centralised - Renewal EMEA/H/C/554/R/39 (2009)7501 of 24/09/2009
09/12/2009 Centralised - Variation EMEA/H/C/554/N/41
Updated with Decision(2010)9640 of 20/12/2010
11/01/2010 Centralised - Variation EMEA/H/C/554/IA/42
23/07/2010 Centralised - Variation EMEA/H/C/554/IA/44
23/12/2010 Centralised - Variation EMEA/H/C/554/II/46 (2010)9640 of 20/12/2010
19/12/2011 Centralised - Variation EMEA/H/C/554/II/47 (2011)9745 of 14/12/2011
12/01/2012 Centralised - Variation EMEA/H/C/554/N/48
Updated with Decision(2013)2403 of 22/04/2013
24/04/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/554/T/50 (2013)2403 of 22/04/2013
21/11/2013 Centralised - Variation EMEA/H/C/554/IAin/51/G
13/12/2013 Centralised - Variation EMEA/H/C/554/N/52
28/02/2014 Centralised - Variation EMEA/H/C/554/IAin/53