Toviaz

fesoterodine

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This is a summary of the European public assessment report (EPAR) for Toviaz. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Toviaz.

What is Toviaz?

Toviaz is a medicine containing the active substance fesoterodine. It is available as prolonged-release 4-mg tablets and 8-mg tablets. Prolonged-release means that fesoterodine is released slowly from the tablet over a few hours.

What is Toviaz used for?

Toviaz is used in adults with overactive-bladder syndrome to treat the symptoms of the disease: increased urinary frequency (need to urinate frequently), urgency (sudden urge to pass urine), and urgency incontinence (sudden lack of control over urination).

The medicine can only be obtained with a prescription.

How is Toviaz used?

The recommended starting dose of Toviaz is 4 mg once a day. The tablets are swallowed whole with a glass of water and must not be chewed. The patient normally gets the full effect of the treatment after two to eight weeks. Based upon individual response, the dose may be increased to 8 mg once daily.

The dose of Toviaz must be adjusted, or the medicine not used at all, in patients with problems with their kidneys or liver, depending on whether they are also receiving ‘CYP3A4 inhibitors’, a group of medicines that may affect the way Toviaz is broken down in the body. See the summary of product characteristics (also part of the EPAR) for full details.

How does Toviaz work?

The active substance in Toviaz, fesoterodine, is an anticholinergic medicine. It blocks some receptors in the body, the muscarinic receptors. In the bladder, this causes the muscles that push urine out of the bladder to relax, leading to an increase in the capacity of the bladder and to changes in the way the bladder muscles contract as the bladder fills up. This helps Toviaz to prevent unwanted urination.

How has Toviaz been studied?

The two main studies involved 1,964 patients with overactive-bladder syndrome and compared Toviaz (4 or 8 mg a day) with placebo (a dummy treatment). One of the studies also compared Toviaz with tolterodine (another medicine used in overactive-bladder syndrome). The main measure of effectiveness was the change in the number of times the patients needed to urinate in a 24-hour period after 12 weeks of treatment.

What benefit has Toviaz shown during the studies?

Toviaz was more effective than placebo and as effective as tolterodine in reducing the number of times the patients urinated in a 24-hour period. Before treatment, patients needed to urinate about 12 times in 24 hours. This number was reduced by 1.74 and 1.86 with the 4-mg dose of Toviaz and by 1.94 with the 8-mg dose. The reductions seen in patients taking placebo and tolterodine were 1.02 and 1.69, respectively.

What is the risk associated with Toviaz?

The most common side effect with Toviaz (seen in more than 1 patient in 10) is dry mouth. For the full list of all side effects reported with Toviaz, see the package leaflet.

Toviaz must not be used in people who are hypersensitive (allergic) to fesoterodine, to any of the other ingredients, to peanut or to soya. Toviaz must also not be used in patients with:

  • urinary retention (difficulty in passing urine);
  • gastric retention (when the stomach does not empty properly);
  • uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment);
  • myasthenia gravis (a disease of the nerves causing muscle weakness);
  • severe hepatic impairment (severe liver disease);
  • severe ulcerative colitis (severe inflammation of the large intestine causing ulceration and bleeding);
  • toxic megacolon (a very serious complication of colitis).

Toviaz must not be given to patients with moderate liver or moderate to severe kidney disease at the same time as strong CYP3A4 inhibitor medicines. These include medicines such as ketoconazole and itraconazole (used to treat fungal infections), atazanavir, indinavir, nelfinavir, ritonavir and saquinavir (medicines used in HIV-positive patients), clarithromycin and telithromycin (antibiotics), and nefazodone (used to treat depression).

Why has Toviaz been approved?

The CHMP decided that Toviaz’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Toviaz

The European Commission granted a marketing authorisation valid throughout the European Union for Toviaz on 20 April 2007.

For more information about treatment with Toviaz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Toviaz : EPAR - Summary for the public BG = bălgarski 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public ES = español 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public CS = čeština 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public DA = dansk 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public DE = Deutsch 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public ET = eesti keel 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public EL = elliniká 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public EN = English 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public FR = français 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public IT = italiano 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public LV = latviešu valoda 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public LT = lietuvių kalba 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public HU = magyar 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public MT = Malti 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public NL = Nederlands 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public PL = polski 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public PT = português 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public RO = română 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public SK = slovenčina 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public SL = slovenščina 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public FI = suomi 25/08/2009 14/09/2012
Toviaz : EPAR - Summary for the public SV = svenska 25/08/2009 14/09/2012

This EPAR was last updated on 09/10/2015 .

Authorisation details

Product details

Product details for Toviaz
NameToviaz
Agency product numberEMEA/H/C/000723
Active substance

fesoterodine fumarate

International non-proprietary name (INN) or common name

fesoterodine

Therapeutic area Urinary Bladder, Overactive
Anatomical therapeutic chemical (ATC) code G04BD11

Publication details

Publication details for Toviaz
Marketing-authorisation holder

Pfizer Limited

Revision17
Date of issue of marketing authorisation valid throughout the European Union20/04/2007

Contact address:

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Product information

Product information

24/06/2015  Toviaz -EMEA/H/C/000723 -N/0046

Name Language First published Last updated
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014
Toviaz : EPAR - Product Information SV = svenska 25/08/2009 15/12/2014

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012
Toviaz : EPAR - All Authorised presentations SV = svenska 05/12/2007 11/10/2012

Pharmacotherapeutic group

Urologicals

Therapeutic indication

Treatment of the symptoms (increased urinary frequency and / or urgency and / or urgency incontinence) that may occur in patients with overactive-bladder syndrome.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Toviaz : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 25/08/2009 09/10/2015
Toviaz-H-C-723-A46-0025 : EPAR - Assessment Report SV = svenska 20/12/2012  

Initial marketing-authorisation documents

Name Language First published Last updated
Toviaz : EPAR - Procedural steps taken before authorisation SV = svenska 05/12/2007  
Toviaz : EPAR - Scientific Discussion SV = svenska 05/12/2007  

Authorised

This medicine is approved for use in the European Union