Elmiron

RSS

pentosan polysulfate sodium

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

Overview

This is a summary of the European public assessment report (EPAR) for Elmiron. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Elmiron.

For practical information about using Elmiron, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 04/09/2018

Authorisation details

Product details
Name
Elmiron
Agency product number
EMEA/H/C/004246
Active substance
pentosan polysulfate sodium
International non-proprietary name (INN) or common name
pentosan polysulfate sodium
Therapeutic area (MeSH)
Cystitis, Interstitial
Anatomical therapeutic chemical (ATC) code
G04BX15
Publication details
Marketing-authorisation holder
bene-Arzneimittel GmbH
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
01/06/2017
Contact address
Herterichstrasse 1-3
81479 Munich
Germany

Product information

14/08/2018 Elmiron - EMEA/H/C/004246 - IB/0008

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

Elmiron is indicated for the treatment of bladder pain syndrome characterized by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition.

Assessment history

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