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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Kentera
|
| Auth. number : | EU/1/03/270 |
| INN : | Oxybutynin |
| ATC: | G - Genito urinary system and sex hormones G04 - Urologicals G04B - Other urologicals, including antispasmodics G04BD - Urinary antispasmodics 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
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register. |
European Commission procedures
| 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 | - | (2005)1598 of 23/05/2005 | |||
| 25/08/2005 | Centralised - Variation | EMEA/H/C/532/IA/8 | ||||
| 25/08/2005 | Centralised - Variation | EMEA/H/C/532/IA/9 | ||||
| Updated with Decision(2006)799 of 09/03/2006 | ||||||
| 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 | - | (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 |