Toviaz
fesoterodine
Table of contents
Overview
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.
Authorisation details
Product details | |
---|---|
Name |
Toviaz
|
Agency product number |
EMEA/H/C/000723
|
Active substance |
fesoterodine fumarate
|
International non-proprietary name (INN) or common name |
fesoterodine
|
Therapeutic area (MeSH) |
Urinary Bladder, Overactive
|
Anatomical therapeutic chemical (ATC) code |
G04BD11
|
Publication details | |
---|---|
Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
27
|
Date of issue of marketing authorisation valid throughout the European Union |
20/04/2007
|
Contact address |
Boulevard de la Plaine 17 |
Product information
10/01/2023 Toviaz - EMEA/H/C/000723 - IA/0067
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.