Sildenafil ratiopharm

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sildenafil

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

Overview

This is a summary of the European public assessment report (EPAR) for sildenafil. 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 sildenafil.

This EPAR was last updated on 09/04/2018

Authorisation details

Product details
Name
Sildenafil ratiopharm
Agency product number
EMEA/H/C/001080
Active substance
sildenafil
International non-proprietary name (INN) or common name
sildenafil
Therapeutic area (MeSH)
Erectile Dysfunction
Anatomical therapeutic chemical (ATC) code
G04BE03
Generic

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 medicines.

Publication details
Marketing-authorisation holder
Ratiopharm GmbH
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
23/12/2009
Contact address
Graf-Arco-Str. 3
D-89079 Ulm
Germany

Product information

20/03/2018 Sildenafil ratiopharm - EMEA/H/C/001080 - N/0039

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 men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for sildenafil to be effective, sexual stimulation is required.

Assessment history

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