This is a summary of the European public assessment report (EPAR) for Spedra. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Spedra.
For practical information about using Spedra, patients should read the package leaflet or contact their doctor or pharmacist.
Spedra : EPAR - Summary for the public (PDF/77.42 KB)
First published: 03/07/2013
Last updated: 10/03/2015
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Menarini International Operations Luxembourg S.A.
|Date of issue of marketing authorisation valid throughout the European Union||
1, Avenue de la Gare
27/10/2020 Spedra - EMEA/H/C/002581 - IB/0033/G
- 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.
Treatment of erectile dysfunction in adult men.
In order for Spedra to be effective, sexual stimulation is required.