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
04/11/2021 Spedra - EMEA/H/C/002581 - N/0035
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Treatment of erectile dysfunction in adult men.
In order for Spedra to be effective, sexual stimulation is required.