Emselex

RSS

darifenacin hydrobromide

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

Overview

This is a summary of the European public assessment report (EPAR) for Emselex. 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 Emselex.

This EPAR was last updated on 12/03/2018

Authorisation details

Product details
Name
Emselex
Agency product number
EMEA/H/C/000554
Active substance
darifenacin hydrobromide
International non-proprietary name (INN) or common name
darifenacin hydrobromide
Therapeutic area (MeSH)
  • Urinary Incontinence, Urge
  • Urinary Bladder, Overactive
Anatomical therapeutic chemical (ATC) code
G04BD10
Publication details
Marketing-authorisation holder
Merus Labs Luxco II S.à R.L.
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
22/10/2004
Contact address
26-28 rue Edward Steichen
L-2540 Luxembourg

Product information

15/02/2018 Emselex - EMEA/H/C/000554 - T/0065

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

Urinary antispasmodics

Therapeutic indication

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.

Assessment history

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