Levitra

RSS

vardenafil

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

Overview

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

This EPAR was last updated on 18/12/2018

Authorisation details

Product details
Name
Levitra
Agency product number
EMEA/H/C/000475
Active substance
vardenafil
International non-proprietary name (INN) or common name
vardenafil
Therapeutic area (MeSH)
Erectile Dysfunction
Anatomical therapeutic chemical (ATC) code
G04BE09
Publication details
Marketing-authorisation holder
Bayer AG 
Revision
28
Date of issue of marketing authorisation valid throughout the European Union
06/03/2003
Contact address
Bayer AG
51368 Leverkusen
Germany

Product information

06/09/2018 Levitra - EMEA/H/C/000475 - WS/1390

Contents

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 erectile dysfunction in adult men.

Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

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

Levitra is not indicated for use by women.

Assessment history

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