Emselex

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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 09/02/2022

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
zr pharma& GmbH
Revision
25
Date of issue of marketing authorisation valid throughout the European Union
22/10/2004
Contact address

Hietzinger Hauptstrasse 37 
1130 Wien 
Austria

Product information

04/02/2022 Emselex - EMEA/H/C/000554 - IAIN/0070/G

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Product information documents contain:

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

  • Drugs for urinary frequency and incontinence

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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