Vivanza

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 Vivanza. 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 Vivanza.

This EPAR was last updated on 14/05/2018

Authorisation details

Product details
Name
Vivanza
Agency product number
EMEA/H/C/000488
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 Pharma AG 
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
04/03/2003
Contact address
Bayer Pharma AG
D-13342 Berlin
Germany

Product information

19/04/2018 Vivanza - EMEA/H/C/000488 - N/0059

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

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 Vivanza to be effective, sexual stimulation is required.

Vivanza is not indicated for use by women.

Assessment history

How useful was this page?

Add your rating