Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Toviaz   
Auth. number : EU/1/07/386
INN : fesoterodine
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: G04BD11 - Fesoterodine
(See WHO ATC Index)
Indication: Treatment of the symptoms (increased urinary frequency and/or urgency and/or urgency incontinence) that may occur in patients with overactive bladder syndrome.
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

  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
24/04/2007 Centralised - Authorisation EMEA/H/C/723 (2007)1855 of 20/04/2007
20/09/2007 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/723/T/1 (2007)4391 of 18/09/2007
13/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/723/IB/2
14/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/723/IA/6
18/12/2007 Centralised - Variation EMEA/H/C/723/IA/5
Updated with Decision(2008)3564 of 07/07/2008
18/12/2007 Centralised - Variation EMEA/H/C/723/IA/7
Updated with Decision(2008)3564 of 07/07/2008
04/02/2008 Centralised - Variation EMEA/H/C/723/IA/11
Updated with Decision(2008)3564 of 07/07/2008
04/02/2008 Centralised - Variation EMEA/H/C/723/IA/10
Updated with Decision(2008)3564 of 07/07/2008
27/03/2008 Centralised - Variation (no change in Commission Decision)
27/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/723/II/8
08/05/2008 Centralised - Notification EMEA/H/C/723/N/12
Updated with Decision(2008)3564 of 07/07/2008
09/07/2008 Centralised - Variation EMEA/H/C/723/II/14 (2008)3564 of 07/07/2008
11/09/2008 Centralised - Variation EMEA/H/C/723/IA/18
Updated with Decision(2008)7798 of 28/11/2008
28/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/723/II/15
02/12/2008 Centralised - Variation EMEA/H/C/723/II/16 (2008)7798 of 28/11/2008
04/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/723/IA/20
03/03/2009 Centralised - Notification EMEA/H/C/723/N/19
Updated with Decision(2009)6195 of 29/07/2009
20/07/2009 Centralised - Variation EMEA/H/C/723/IB/22
Updated with Decision(2010)893 of 08/02/2010
20/07/2009 Centralised - Variation EMEA/H/C/723/IB/23
Updated with Decision(2010)893 of 08/02/2010
31/07/2009 Centralised - Variation EMEA/H/C/723/II/21 (2009)6195 of 29/07/2009
04/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/723/II/24
10/02/2010 Centralised - Variation (2010)893 of 08/02/2010
22/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/723/IB/27
08/06/2010 Centralised - Variation EMEA/H/C/723/II/25 (2010)3702 of 04/06/2010
29/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/723/IA/30/G
09/08/2010 Centralised - Variation (refusal)
27/10/2010 Centralised - Variation EMEA/H/C/723/II/31 (2010)7537 of 25/10/2010
20/01/2011 Centralised - Variation EMEA/H/C/723/IB/32
Updated with Decision(2011)2086 of 24/03/2011
28/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/723/IG/44/NC
30/03/2011 Centralised - Variation EMEA/H/C/723/II/29 (2011)2086 of 24/03/2011
26/10/2011 Centralised - Variation EMEA/H/C/723/II/33 (2011)7775 of 24/10/2011
19/03/2012 Centralised - Renewal EMEA/H/C/723/R/34 (2012)1863 of 15/03/2012
28/09/2012 Centralised - Variation EMEA/H/C/723/IAin/39/G
Updated with Decision(2012)7717 of 25/10/2012
29/10/2012 Centralised - Variation (2012)7717 of 25/10/2012
23/10/2014 Centralised - Variation EMEA/H/C/723/IAIN/45