Levitra
vardenafil
Table of contents
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.
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Levitra : EPAR - Summary for the public (PDF/87.99 KB)
First published: 25/08/2009
Last updated: 29/03/2016 -
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Levitra : EPAR - Risk-management-plan summary (PDF/58.42 KB)
First published: 27/06/2019
Authorisation details
Product details | |
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Name |
Levitra
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Agency product number |
EMEA/H/C/000475
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Active substance |
vardenafil
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International non-proprietary name (INN) or common name |
vardenafil
|
Therapeutic area (MeSH) |
Erectile Dysfunction
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Anatomical therapeutic chemical (ATC) code |
G04BE09
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Publication details | |
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Marketing-authorisation holder |
Bayer AG
|
Revision |
31
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Date of issue of marketing authorisation valid throughout the European Union |
06/03/2003
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Contact address |
Product information
19/03/2020 Levitra - EMEA/H/C/000475 - WS/1750
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 Levitra to be effective, sexual stimulation is required.
Levitra is not indicated for use by women.