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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List item
Levitra : EPAR - Summary for the public (PDF/87.99 KB)
First published: 25/08/2009
Last updated: 29/03/2016 -
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List item
Levitra : EPAR - Risk-management-plan summary (PDF/58.42 KB)
First published: 27/06/2019
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 |
32
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Date of issue of marketing authorisation valid throughout the European Union |
06/03/2003
|
Contact address |
Bayer AG |
Product information
20/10/2021 Levitra - EMEA/H/C/000475 - N/0067
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.