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.
Vivanza : EPAR - Summary for the public (PDF/82.01 KB)
First published: 24/08/2009
Last updated: 30/03/2016
Vivanza : EPAR - Risk-management-plan summary (PDF/52.37 KB)
First published: 02/07/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Bayer Pharma AG
|Date of issue of marketing authorisation valid throughout the European Union||
06/09/2018 Vivanza - EMEA/H/C/000488 - WS/1390
- 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
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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.