Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Kentera   
Auth. number : EU/1/03/270
INN : Oxybutynin
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: G04BD04 - Oxybutynin
(See WHO ATC Index)
Indication: Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with unstable bladder
Marketing Authorisation Holder: Nicobrand Limited
189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP, United Kindom

  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
18/06/2004 Centralised - Authorisation EMEA/H/C/532 (2004)2191 of 15/06/2004
27/07/2004 Centralised - Variation EMEA/H/C/532/IA/3
29/10/2004 Centralised - Variation EMEA/H/C/532/IB/4
Updated with Decision(2005)1598 of 23/05/2005
25/11/2004 Centralised - Variation EMEA/H/C/532/IB/6
Updated with Decision(2005)1598 of 23/05/2005
21/02/2005 Centralised - Variation EMEA/H/C/532/II/5
21/04/2005 Centralised - Variation EMEA/H/C/532/IA/7
25/05/2005 Centralised - Variation EMEA/H/C/532 (2005)1598 of 23/05/2005
25/08/2005 Centralised - Variation EMEA/H/C/532/IA/9
Updated with Decision(2006)799 of 09/03/2006
25/08/2005 Centralised - Variation EMEA/H/C/532/IA/8
02/12/2005 Centralised - Variation EMEA/H/C/532/N/10
Updated with Decision(2006)799 of 09/03/2006
13/03/2006 Centralised - Variation EMEA/H/C/532 (2006)799 of 09/03/2006
31/10/2006 Centralised - Variation EMEA/H/C/532/IA/11
22/08/2007 Centralised - Variation EMEA/H/C/532/N/12
Updated with Decision(2009)3573 of 30/04/2009
28/08/2008 Centralised - Variation EMEA/H/C/532/N/13
Updated with Decision(2009)3573 of 30/04/2009
05/05/2009 Centralised - Renewal EMEA/H/C/532/R/14 (2009)3573 of 30/04/2009
10/12/2009 Centralised - Variation EMEA/H/C/532/N/15
Updated with Decision(2010)8128 of 12/11/2010
20/09/2010 Centralised - Variation EMEA/H/C/532/IB/17/G
Updated with Decision(2010)8128 of 12/11/2010
27/09/2010 Centralised - Variation EMEA/H/C/532/N/18
Updated with Decision(2010)8128 of 12/11/2010
04/10/2010 Centralised - Variation EMEA/H/C/532/IA/19/G
Updated with Decision(2010)8128 of 12/11/2010
16/11/2010 Centralised - Variation (2010)8128 of 12/11/2010
24/05/2011 Centralised - Variation EMEA/H/C/532/IA/20
Updated with Decision(2011)9958 of 19/12/2011
30/08/2011 Centralised - Variation EMEA/H/C/532/X/16 (2011)6147 of 24/08/2011
07/12/2011 Centralised - Variation EMEA/H/C/532/N/25
21/12/2011 Centralised - Variation (2011)9958 of 19/12/2011
20/12/2013 Centralised - Variation EMEA/H/C/532/N/34