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.
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 |
12
|
Date of issue of marketing authorisation valid throughout the European Union |
21/06/2013
|
Contact address |
1, Avenue de la Gare |
Product information
27/10/2020 Spedra - EMEA/H/C/002581 - IB/0033/G
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
Therapeutic indication
Treatment of erectile dysfunction in adult men.
In order for Spedra to be effective, sexual stimulation is required.