Tadalafil Lilly
tadalafil
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Tadalafil Lilly. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Tadalafil Lilly.
For practical information about using Tadalafil Lilly, patients should read the package leaflet or contact their doctor or pharmacist.
Authorisation details
Product details | |
---|---|
Name |
Tadalafil Lilly
|
Agency product number |
EMEA/H/C/004666
|
Active substance |
tadalafil
|
International non-proprietary name (INN) or common name |
tadalafil
|
Therapeutic area (MeSH) |
Erectile Dysfunction
|
Anatomical therapeutic chemical (ATC) code |
G04BE08
|
Publication details | |
---|---|
Marketing-authorisation holder |
Eli Lilly Nederland B.V.
|
Revision |
6
|
Date of issue of marketing authorisation valid throughout the European Union |
22/03/2017
|
Contact address |
Papendorpseweg 83 |
Product information
23/08/2023 Tadalafil Lilly - EMEA/H/C/004666 - PSUSA/00002841/202210
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 males.
In order for tadalafil to be effective, sexual stimulation is required.
Tadalafil Lilly is not indicated for use by women.
Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.