Silodosin Recordati

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silodosin

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

Overview

Silodosin Recordati is a medicine used to treat the symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate gland) in adults. The prostate gland is an organ found at the base of the bladder in men. When enlarged, it can cause problems with the flow of urine.

This medicine is identical to Urorec, which has been authorised in the EU since 29 January 2010.

This EPAR was last updated on 22/01/2019

Authorisation details

Product details
Name
Silodosin Recordati
Agency product number
EMEA/H/C/004964
Active substance
silodosin
International non-proprietary name (INN) or common name
silodosin
Therapeutic area (MeSH)
Prostatic Hyperplasia
Anatomical therapeutic chemical (ATC) code
G04CA04
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Recordati Ireland Ltd
Date of issue of marketing authorisation valid throughout the European Union
07/01/2019
Contact address

Raheens East
Ringaskiddy
Co. Cork
Ireland

Product information

07/01/2019 Silodosin Recordati - EMEA/H/C/004964 -

Contents

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Pharmacotherapeutic group

  • UROLOGICALS
  • Alpha-adrenoreceptor antagonists

Therapeutic indication

Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.

Assessment history

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