Urorec

RSS

silodosin

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

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 16/05/2018

Authorisation details

Product details
Name
Urorec
Agency product number
EMEA/H/C/001092
Active substance
silodosin
International non-proprietary name (INN) or common name
silodosin
Therapeutic area (MeSH)
Prostatic Hyperplasia
Anatomical therapeutic chemical (ATC) code
G04CA04
Publication details
Marketing-authorisation holder
Recordati Ireland Ltd
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
29/01/2010
Contact address
Raheens East
Ringaskiddy, Co. Cork
Ireland

Product information

12/04/2018 Urorec - EMEA/H/C/001092 - N/0033

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 signs and symptoms of benign prostatic hyperplasia (BPH).

Assessment history

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