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.
Levitra : EPAR - Summary for the public (PDF/87.99 KB)
First published: 25/08/2009
Last updated: 29/03/2016
Levitra : EPAR - Risk-management-plan summary (PDF/58.42 KB)
First published: 27/06/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
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.
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.