Emselex
darifenacin hydrobromide
Table of contents
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.
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) |
|
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 |
Product information
04/02/2022 Emselex - EMEA/H/C/000554 - IAIN/0070/G
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
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Urologicals
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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.