Toviaz

RSS

fesoterodine

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 07/08/2018

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
20
Date of issue of marketing authorisation valid throughout the European Union
20/04/2007
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

30/07/2018 Toviaz - EMEA/H/C/000723 - T/0052

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.

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

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