Spedra

RSS

avanafil

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

Overview

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.

This EPAR was last updated on 02/05/2018

Authorisation details

Product details
Name
Spedra
Agency product number
EMEA/H/C/002581
Active substance
avanafil
International non-proprietary name (INN) or common name
avanafil
Therapeutic area (MeSH)
Erectile Dysfunction
Anatomical therapeutic chemical (ATC) code
G04BE10
Publication details
Marketing-authorisation holder
Menarini International Operations Luxembourg S.A.
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
21/06/2013
Contact address
1, Avenue de la Gare
L-1611 Luxembourg
Luxembourg

Product information

23/04/2018 Spedra - EMEA/H/C/002581 - R/0029

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

Drugs used in erectile dysfunction

Therapeutic indication

Treatment of erectile dysfunction in adult men.

In order for Spedra to be effective, sexual stimulation is required.

Assessment history

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